Ian Jacka

10 South Colonnade 
Canary Wharf 
London 
E14 4PU 
United Kingdom 
gov.uk/mhra 

Mr Guy Davies 
HM Assistant Coroner 
Cornwall & the Isles of Scilly Coroner’s Area 

7 May 2024 

Dear Mr Davies, 

Regulation 28 report relating to the death of Ian Jacka (DOD 15/06/2022) 

Thank you for your Regulation 28 Report relating to the death of Ian Jack (DOD 15/06/2022) 
which was received on 2 January 2024. I would like to offer my sincere condolences to Mr 
Jacka’s family on their tragic loss.  

Following receipt of the Regulation 28 Report we have considered the points of concern 
raised regarding the use of the Cook Airway Exchange (CAE) catheter, manufactured by 
Cook Medical, with the Manujet III manufactured by VMB. 

Firstly, it may be helpful to provide background information relating to the Medicines and 
Healthcare products Regulatory Agency (MHRA) and the work we carry out. The MHRA is 
the executive Agency of the Department of Health and Social Care that acts on behalf of the 
Ministers to protect and promote public health and patient safety by ensuring that medicines 
and healthcare products can be used safely and meet appropriate standards of safety, 
quality, performance, and effectiveness. Medical devices such as these must comply with 
the medical device regulatory requirements and be CE or UKCA marked which is certified by 
notified bodies or approved bodies.  

When an adverse incident involving a medical device is reported to the MHRA, we liaise with 
the manufacturer of the medical device(s) and request that they investigate and test the 
device(s). The MHRA assesses the balance of risks and benefits of devices, throughout their 
use in clinical practice, through the collection of information and assessment of any potential 
risks. This may be followed, when necessary, with communications and regulatory action to 
minimise those risks.  

 
 
 
 
 
 
 
 
 
 
  
 
 The Regulation 28 report concerns an incident that occurred on the 6 June 2022 at Derriford 
Hospital where a CAE catheter was used with a Manujet III, which is a manually controlled 
oxygen delivery system, to facilitate airway exchange in a complex polytrauma patient 
undergoing complex spinal surgery.  

It is understood that prior to surgery there were several unsuccessful attempts to intubate. 
However, an oral endotracheal tube (ETT) was successfully placed and subsequently 
replaced with an armoured ETT for the duration of the operation. At the end of the surgery 
the CAE Catheter was used to aid the replacement of the armoured ETT for a more flexible 
critical care ETT. There were several unsuccessful attempts to insert the replacement ETT 
resulting in the patient experiencing oxygen desaturation. Therefore, jet ventilation was 
performed with Manujet III using the CAE Catheter. Subsequently, the patient experienced 
subcutaneous emphysema and cardiac arrest. As result of this event and the additional time 
needed to establish an alternative secure airway (i.e. cricothyroidotomy), the patient 
experienced hypoxic brain damage and died several days later. 

We were initially informed of this incident on 22 March 2023 through a Yellow Card report 
from a healthcare professional and also received a report from Cook Medical. However, no 
report was received directly from Derriford Hospital. Additionally, no product was returned to 
Cook Medical for evaluation. We informed Cook and requested they investigate the reported 
incident.  

Cook Medical investigated and concluded that the cause of the failure could be associated 
with an unintended use error. They indicate the device was used in a patient with a difficult 
airway, the catheter was over-inserted, and jet ventilation may not have been used in a 
manner consistent with the instructions for use (IFU). We note the difference in opinion with 
the medical team around over insertion. 

We have received no other incident reports within the last 10 years where an issue occurred 
with AEC and jet ventilation being used together during endotracheal intubation.  

Please see our response to the matters of concern raised below. 

(1)  The Inquest found that the use of the ManuJet III Ventilator with Cook Airway 

Exchange Catheter (AEC) likely contributed to Ian’s death. This finding was based 
primarily on the evidence of the NHS investigation. It was found that the second 
use of the jet resulted in significantly increased airway pressure which caused 
tension pneumothoraxes and massive subcutaneous emphysema.  

In this incident the CAE Catheter was initially being used with the Manujet III during an 
endotracheal tube (ETT) exchange. Endotracheal intubation involves a tube being 
placed through the mouth or nose into the windpipe. The incident describes multiple 
failed attempts at intubation indicating this was a difficult airway. However, the Cook 
airway exchange is intended for uncomplicated atraumatic endotracheal tube exchange 
where a ventilatory device may be used at any time during the procedure by using the 
Rapi-Fit Adaptor provided with the device. The IFUs provided with the device note that; 

“Use of a high-pressure oxygen source should only be considered if the patient has a 
sufficient egression of the insufflated gas volume.”  

 
 
 
 
 
 
  
 
 This incident describes that; 
“.. having removed the armoured tube, the team were unable to insert the flexible tube 
despite repeated attempts. Ian then started to desaturate due to lack of oxygen. The 
Consultant Anaesthetist proceeded to jet ventilate Ian using a ManuJet III Ventilator with 
Cook Airway Exchange Catheter.”  

The Manujet III can be used electively for microlaryngoscopy, rigid bronchoscopy, to 
assist a difficult fibreoptic intubation or during a predicted difficult extubation. However, 
the IFU states the intended use of the device is to provide transtracheal ventilation, in 
specific emergency situations. The IFUs specifies two types of emergency use with one 
including a lifesaving manoeuvre in the “cannot intubate – cannot ventilate “ situation for 
oxygenation to avoid severe desaturation of the patient. Transtracheal ventilation is 
achieved in conjunction with a transtracheal catheter, placed percutaneously into the 
trachea or using cricothyrotomy device inserted through the cricothyroid membrane. The 
second specified emergency use is for prehospital use if there is a partial obstruction of 
the upper airway. The IFUs indicate that in emergency situations the transtracheal jet 
ventilation (TTJV) has fewer complications and is faster and simpler as a surgical 
cricothyrotomy. The Manujet III is sold in a kit including Jet Ventilation Catheters. 

The Manujet III is a manually operated device and the IFUs indicate the user must adjust 
the ventilation pressure and ventilation frequency properly to achieve balanced 
ventilation. Additionally, the IFUs have safety instructions which include that: 
“The user must ensure that expiration takes place via the upper airways. A total 
obstruction is a contra-indication for the use of Manujet III with Jet Ventilation Catheter. If 
another way of securing the airway is not possible and expiration is not assured, 
ventilation frequency should be reduced to 3 strokes per minute to avoid barotrauma. 
This can be sufficient as a life-saving manoeuvre in case of a total upper airway 
obstruction.” 

(2)  Had the ManuJet III not been used to provide oxygenation during airway exchange 
it is unlikely that the scenario would have deteriorated to cardiac arrest so rapidly.  

Please see answer to question 1 

(3)  It was found at Inquest that the outcome would have been different if the ventilator 
had incorporated an adjustable pressure limiting valve, allowing control of the 
flow pressure. This is not possible with the ManuJet. The ManuJet does not have 
automated pressure sensing capabilities to it which will reduce or cease delivery if 
it senses the pressure in the airway being too high.  

The Manujet III is a manually operated device and the IFUs instruct the user to:  
“Adjust the desired ventilation pressure by turning the pressure regulator knob clockwise. 
Start with the lowest pressure (0 bar/psi) and afterwards increase this pressure slowly 
under ventilation and clinical control of chest movements. The adjusted ventilation 
pressure is displayed on the gauge. Push the pressure regulator knob for locking. To re-
adjust the pressure, pull the pressure regulator knob and adjust to the desired pressure.”  

The Manujet III IFU does indicate there is a maximum operation pressure of 4 bar (58 
psi) and the pressure regulator and gauge ensure that the maximum operation pressure 
of 4 bar (58 psi) is not exceeded.  

 
 
 
 
 
 
 
 
 (4)  The Inquest conclusion supported the finding in the NHS Investigation that the 
design of the Cook AEC is flawed and that it needs to be redesigned and in 
addition requires markings or a colour change at the maximal depth of 26cm. The 
Inquest found that there had been no over-insertion in Ian’s case, but the risk of 
over insertion was noted by clinicians.  

The Cook AEC IFUs clearly indicate it is only intended for uncomplicated atraumatic 
endotracheal tube exchange. Additionally, Manujet III can be used electively for 
specified types of intubations, however the IFUs state its intended is for transtracheal 
ventilation for lifesaving manoeuvres e.g., “cannot intubate – cannot ventilate “ for 
oxygenation, to avoid severe desaturation of the patient. 

It is also worth noting the IFU for the CAE Catheter warns to avoid barotrauma by 
ensuring the tip of the CAE Catheter is, “ always above the carina, preferably 2-3 cm”. It 
also instructs users to; 
“Properly position the CAE Catheter within the endotracheal tube by aligning the 
appropriate centimeter mark on the CAE Catheter with the corresponding centimeter 
mark on the endotracheal tube. This placement is determined by visualising the 
indicated centimeter length of the endotracheal tube, in place, as shown on the surface 
scale. (For example, an endotracheal tube that has been shortened to 24cm should 
have the 24cm marker of the CAE Catheter aligned at the 24cm mark of the 
endotracheal tube.)” 

In response to the suggested colour changes at a maximal depth of 26cm, variation in 
patient anatomy would mean that a maximal depth marking of 26cm may not be suitable 
for every patient (i.e. to position the catheter 2-3 cm above the carina). Also producing 
colour on a plastic catheter may introduce other risks. Furthermore, it is widely accepted 
the use of colour can introduce confusion due to the potential diversity amongst 
manufacturers leading to errors in use, and therefore is not recommended.  

(5) Following the NHS investigation into Ian’s death, Derriford Hospital have 

prohibited the use of jet ventilation via the Cook AEC outside of ENT and thoracic 
surgery without the use of a rigid bronchoscope. The hospital has removed 
ManuJet ventilators from theatres (apart from ENT and thoracic surgery).  

Please see answer to question 1 

In conclusion, this incident describes the use of the Cook Airway Exchange (CAE) 
Catheter, manufactured by Cook Medical, and Manujet III ventilator manufactured by 
VBM. However, the CAE Catheter is not intended for complicated airways. Additionally, 
the IFUs for the Manujet III ventilator indicate it can be used electively for specified types 
of intubations. However, it is intended to be used via transtracheal ventilation for 
lifesaving manoeuvres e.g., “cannot intubate – cannot ventilate “ for oxygenation, to 
avoid severe desaturation of the patient. 

We keep the safe and effective use of medical devices, including airway exchange 
catheters and manual jet ventilators, under continual review. We will further consider the 
issues raised in the report and will raise them with the manufacturer of these devices. 

 
 
 
 
 
 
 
 
 
 We would request the manufacturers are provided with a copy of the Regulation 28 
Report or agreement that we can provide them with a copy of the Regulation 28 report 
directly. Additionally, we will work with the manufacturers of these devices to explore if 
any further action including any further risk communication and/or provision of 
information is required to help prevent any future recurrence of this issue.  

Our guidance on Managing Medical Devices is about the use and management of 
medical devices. This indicates that instructions may need to be written locally to cover 
whole systems where devices are used together with other devices. If healthcare 
organisations draft their own instructions to supplement the manufacturer’s instructions, 
consider consulting the manufacturer/supplier on their accuracy and suitability, before 
issue. Further information can be found in the Managing Medical Devices guidance 
available online at https://www.gov.uk/government/publications/managing-medical-
devices. 

Should you have any further questions, please do not hesitate to contact me. 

Yours sincerely, 

Chief Executive 
Medicines and Healthcare products Regulatory Agency

Graham.clowes@nationaltrust.org.uk 
7th March 2024 

Information Classification: CONTROLLED 

Mr G Davies 
His Majesty’s Assistant Coroner for  
Cornwall & the Isles of Scilly, 
Cornwall Coroners' Service,  
Pydar House, 
Pydar Street,  
Truro,  
TR1 1XU 

Dear Mr Davies, 

Re: Regulation 28: Report to Prevent Future Deaths in the Matter of the Inquest Touching 
the Death of Ian Jacka 

I am Head of Compliance for the National Trust and am writing in response to the 
Prevention of Future Death Report dated 27 December 2023 following the conclusion of the 
inquest touching upon the death of Ian Jacka. Thank you for agreeing to extend the time for 
the National Trust to respond. 

The National Trust has considered your Report with care and taken expert advice from the 
Visitor Safety Group (VSG), who you will recall from the evidence produce the definitive 
guidance applicable to risk assessments at locations such as Chapel Porth, before 
reviewing its risk assessment and responding to your Report.  

On 9 February 2024 four members of the VSG board visited the site, including the specific 
, VSG Chair and 
location where Ian fell. Those attending from the VSG included 
editor/co-author of ‘Managing Visitor Safety in the Countryside – principles & practice’. They 
were provided with the following context: 

The National Trust car park has space for around 60 cars  
At busy times, a local landowner provides additional spaces in a field further up the lane. 
The lane is a dedicated highway, outside the ownership of the National Trust  
There are an estimated 160,000 annual visits, with a significant proportion being local.  
UNESCO World Heritage Site designation (mining history)  
SSSI and SAC designations  
The Southwest Coastal Path passes through the site, joining the lane a little way below the 
location of the accident 
The National Trust is not aware of any previous incidents in the area where Mr Jacka fell. 

National Trust 
Heelis 
Kemble Drive 
Swindon  
SN2 2NA 
Tel: +44 (0)1793 817400 
Fax: +44 (0)1793 817401 
www.nationaltrust.org.uk 

Registered office:  
Heelis, Kemble Drive, Swindon, Wiltshire SN2 2NA 
Registered charity number 205846 

 
 
 
 
 
 
 
 
 
  
  
  
  
 Information Classification: CONTROLLED 

The VSG group was provided with a copy of the Prevention of Future Death Report prior to 
the visit and was aware of the circumstances surrounding the fall. So as to ensure they were 
uninfluenced by the risk assessments of others, the VSG were not provided with copies of 
the Cormac/Cornwall Council or the National Trust risk assessments prior to the visit.  

 reported that he and each VSG Board Member separately reached the conclusion 

that it would not be appropriate to introduce a ‘risk of fall sign’ or fencing. There was 
agreement that the hazard was reasonably obvious, with the likelihood of someone falling 
where the drop was greatest being remote. There was, in consequence, no reasonable 
requirement for signs or barriers at this location. The participants observed there were many 
other unguarded drops in the vicinity, and it would not be reasonably practicable to treat 
them in a similar manner, should a precedent be set at the accident site. Nor would signs 
and barriers be desirable interventions as they would detract from the landscape value and 
have an adverse effect on the special characteristics that underpin the designations listed 
above. 

The VSG representatives were provided with copies of the National Trust’s and Cormac’s 
risk assessments after the site visit. 

In summary, VSG participants were satisfied that the National Trust in its visitor risk 
management at Chapel Porth, had followed the VSG guiding principles. Two of particular 
relevance are:  

1. Fundamentals  

• Take account of conservation, heritage, recreation, cultural and landscape objectives.  
• Do not take away people’s sense of freedom and adventure.  
• Avoid restrictions on access. 

4. Responsibility  

• It is important to strike a balance between visitor self-reliance and management 
intervention.  
• It is reasonable to expect parents, guardians and leaders to supervise people in their care.  
• It is reasonable to expect visitors to exercise responsibility for themselves.  
• It is reasonable to expect visitors not to put others at risk. 

The VSG was concerned that you had found the National Trust’s Risk Assessment in place 
at the time of the accident, to be ‘flawed and unreliable.’ They advised that they do not 
agree with that view. They reviewed the risk assessment and concluded that it 
demonstrated a sensible, thorough process carried out by someone familiar with VSG 
principles. The hazard of fall from height is recognised and there is a listing under current 
precautions that ‘The highest point from the road to the car park is walled off so the edge is 
inaccessible and clearly visible’. The accompanying photographs demonstrate that the 
assessor looked at the site in the vicinity of the accident. The existing controls for falls from 
height are judged to be adequate.  

A cause for concern set out in the PFD report was the absence of any discussion of control 
measures such as the signage and barriers that Cornwall Highways suggested following the 
accident. The VSG representatives recognised that the risk assessment might benefit from a 
statement explaining the need to avoid unnecessary and intrusive signs and barriers, but in 

2 

 
 
 
 
 
  
  
  
  
 
  
 
  
 
 Information Classification: CONTROLLED 

their view that would not have altered the conclusion that the residual risk on the site was 
acceptable without the need to introduce additional risk controls. 

 advised that he also reviewed the Cornwall Council risk assessment dated 20 

March 2023. He commented as follows: 

"It uses a risk matrix table of likelihood multiplied by severity of consequence to produce a 
score, where 15 or above is deemed unacceptable. Two hazards produced a score of 15. 
‘Unprotected edge - Fall from height.’ And ‘Kerb at edge of carriage – trips, slips, falls when 
accessing adjacent private verge.’ Scoring is subjective. However, my judgement is that 
likelihood is scored too high. Few visitors seem likely to go near the edge, or indeed choose 
to walk onto the verge. The lack of incident reports over the past dozen or so years would 
appear to support this 

The Cornwall Highways Risk Assessment applies the highest score (5, ‘catastrophic’) for the 
severity of consequence. However, a trip over the kerb would be most likely to result in no 
injury or a minor first aid case. The slope between the kerb and the drop is relatively gentle, 
so the risk of a fall from height following the trip is greatly diminished. 

The Cornwall Highways Risk Assessment recommends provision of a ‘pedestrian edge 
restraint to prevent falls from height and user accessing private verge’. To be effective, the 
barrier would need to have properties such as provided for fencing quarries. It would be 
visually intrusive and create a potential crush hazard for pedestrians on the road when 
encountering vehicles. None of the VSG Board Members judged this desirable.  

We note that the Cornwall Highways Risk Assessment methodology does not appear to 
have any way to consider the site in context. In consequence, risk controls are proposed 
without any consideration of potential adverse effects on landscape designations or other 
benefits to the public." 

In conclusion, The VSG was satisfied that VSG principles remain valid, and had been 
applied appropriately by the National Trust. 

Following receipt of the VSG’s advice, the National Trust completed a further risk 
assessment at Chapel Porth focussing on the location of Mr Jacka`s fall. Based upon the 
finding of the risk assessment and applying VSG guidance, the Trust has decided not to 
install fencing at the location or a sign warning of the risk of falls for the following reasons:- 

-The hazard is obvious. The likelihood of someone falling where the drop is greatest is 
remote. There are no reports of any incidents of falls prior to 3 June 2022 or after.  

-A trip over the kerb would be most likely to result in no injury or a minor first aid case. The 
slope between the kerb and the drop is relatively gentle, so the risk of a fall from height 
following the trip is greatly diminished. 

-There is no reasonable requirement for warning signs or barriers at this location. There are 
many other unguarded drops in the vicinity, and it would not be reasonably practicable to 
treat them in a similar manner, should a precedent be set at the accident site. Nor would 
signs and barriers be desirable interventions as they would detract from the landscape value 
and have an adverse effect on the special characteristics that underpin the designations 
listed above. 

3 

 
 
 
 
 
  
  
  
  
  
  
  
  
  
  
 Information Classification: CONTROLLED 

-To be effective, any barrier would need to have properties such as provided for fencing 
quarries. It would be visually intrusive and create a potential crush hazard for pedestrians on 
the road when encountering vehicles. 

The VSG suggested Cornwall Council should consider installing further signage on the road 
that might lesson the need for pedestrians to step off the road onto the verge. Cars exiting 
the car park, whose drivers have a clear view of any pedestrians on the road, are less of an 
issue than vehicles arriving. The view of the road ahead is more restricted for vehicles 
arriving at the site and their approach speed is likely to be higher. The VSG suggested 
discussions with Cornwall Council to consider use of further road signs to reduce speed and 
warn of pedestrians in the road. The VSG suggested the following signs be considered.  

.   

The National Trust will be contacting Cornwall Council to inform them of the suggestions 
made by the VSG. The National Trust will review the risk assessment at Chapel Porth on an 
annual basis in accordance with its risk assessment policy. 

Yours sincerely 

Head of Compliance 

4

Deputy Medical Director 
Derriford Hospital 
Derriford Road 
Plymouth 
PL6 8DH  

Date: 2nd February 2024  

Private and Confidential 

Dear Mr Davies, 

I am writing in response to your recently issued Regulation 28 Report dated the 7th of December 2023 
concerning the sad death of Mr Ian Jacka. On behalf of University Hospitals Plymouth NHS Trust, We 
would like to begin by offering our sincere condolences to Mr Jacka’s family for their loss. 

Thank you for highlighting the concerns regarding Mr Jacka’s death, we apologise that you have had 
to  bring  these  concerns  to  our  attention.  We  understand  the  severity  of  your  concerns  and  are 
committed to making the necessary improvements that ensures the quality and safety of our services 
and  prevents  harm  to  future  patients.  A  full  investigation  into  each  of  your  concerns  has  been 
undertaken and I have documented our response below. I hope that this response will satisfy you that 
we have robust processes in place and have taken the necessary action required to prevent a future 
death.  

  There  was  an  error  of  omission  in  record  keeping  and  in  handover  from  critical  care  to 

surgery, and that this error likely contributed to Ian’s death.  

  There was no entry in Ian’s hospital notes to indicate the full extent of the critical incident 

of 5 June 2022.  

  There  was  a  lack  of  information  on  handover  from  critical  care  to  the  surgical  team 
regarding  the  full  extent  of  the  critical  incident  of  the  5  June  2022.  There  was  a  verbal 
handover  which  was  brief  and  vague.  There  was  no  formal  written  handover  process 
highlighting significant events.  

  The  error  of  omission  was  unexplained  and  has  not  been  investigated  by  the  NHS.  The 
evidence  regarding  the  error  of  omission  came  to  light  after  the  completion  of  the  NHS 
investigation  into  Ian’s  death.  The  Consultant  Anaesthetist  involved  in  Ian’s  operation 
discovered the fact of the critical incident of 5 June 2022 on a later examination of ventilator 
data. The data indicated that Ian deteriorated significantly, that he was close to a cardiac 
arrest and the critical care team saved his life.  

We have undertaken a full review of the record keeping and handover arrangements relating to this 
Mr Jacka’s care. A review of Mr Jacka’s clinical records demonstrated that the event that occurred in 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 the early hours of the 5th June 2022 was documented following the event at 04:24 in the intensive 
care Electronic Patient Record System (Innovian) by the medical team.  

The documentation in relation to the critical incident is both comprehensive and appropriate. Mr Jacka 
deteriorated, requiring intubation and ventilation as a result of type 2 respiratory failure caused by 
his  significant  chest  and  spinal  injuries.  His  blood  oxygen  saturations  and  blood  pressure  fell 
significantly  but  were  rapidly  restored  to  normal  upon  the  arrival  of  the  ICU  registrar  with  simple 
interventions after a relatively short period of time. The lowest oxygen saturations and blood pressure 
values  were  recorded  in  the  notes  by  the  ICU  nurse  at  the  time.  Mr  Jacka  was  anaesthetised  and 
intubated – this was technically challenging and represented a difficult airway, but Mr Jacka remained 
stable throughout this process with no further drop in oxygen levels. Following successful intubation, 
the  Intensive  Care  Registrar  documented  a  plan  for  ongoing  sedation  overnight,  and  for  the 
Neurosurgeons  to  be  informed.  A  plan  for  subsequent  intubation  was  also  documented  which 
included  appropriate  recommendations  for  airway  management;  “For  further  intubations:  Awake 
fibreoptic if situation permits, or CMAC D + bouguie + collar off”.  

The  airway  technique  used  and  the  difficulties  encountered  during  the  intubation  were  both 
documented in Mr Jacka’s medical notes and verbalised to the anaesthetic team when they reviewed 
Mr Jacka pre-operatively on the 6th June 2022. The anaesthetic Pre-assessment Record completed by 
the Anesthetic Registrar pre-operatively documented the following in the ‘Intubation hazards’ section; 
“emergency  intubation  –  V  difficult.  Size  7  ETT.  Grade  4.  CMAC  D  blade  –  epiglottis  only.  Able  to 
ventilate with FM and Guedel. Size 7.0 ETT”. This is consistent with the details documented within the 
intensive  care  Electronic  Patient  Record  System  following  the  event  on  the  5th  June  2022  and 
demonstrates that there was not an omission in record keeping or handover. 

Investigation into events performed after Mr Jacka’s death did not identify missing information from 
the clinical record, or evidence that his deterioration was more significant than that documented in 
the contemporaneous record. 

  The surgical and anaesthetic team had no reason to suspect a secondary brain injury. The 
team had no information on Ian’s neurological status. Ian is likely to have suffered a hypoxic 
brain injury during the critical incident of 5th June. This will have undermined his resilience 
and ability to physically withstand the rigors of spinal surgery and airway exchange.  

A review of Mr Jacka’s clinical records identified that the Neurosurgical team reviewed him on the 5th 
June  2022  at  09:00  and  Mr  Jacka’s  deterioration  and  the  need  for  intubation  and  ventilation  was 
acknowledged. The Neurosurgical team planned for surgery to be performed on the 6th June 2022, 
and a GCS assessment (an assessment to objectively describe the extent of impaired consciousness) 
was to be undertaken.  

Mr Jacka was also reviewed by the Intensive Care Consultant on the 5th June 2022 at 11:13 and it was 
noted that he had been intubated in the early hours of the morning secondary to type 2 respiratory 
failure. A plan for a pause in sedation administration to facilitate a GCS assessment prior to surgery 
on the 6th June 2022 was documented. 

The GCS assessment was undertaken by the Intensive Care Consultant on the 5th June 2022 at 16:41. 
Mr  Jacka  was  recorded  to  have  been  obeying  commands  whilst  under  sedation  with  a  GCS  score 
breakdown of Eyes-4 (eyes opening spontaneously), and Motor-6 (obeying commands).  

In conclusion, based on the clinical information reviewed there is evidence that Mr Jacka did not suffer 
a hypoxic brain injury as a result of his deterioration in the early hours of the 5th June 2022. Mr Jacka 

 
 
 
 
 
 
 
 
 was opening his eyes spontaneously immediately after his acute deterioration, and a GCS assessment 
was undertaken which confirmed that Mr Jacka was able to open his eyes spontaneously and obey 
commands.  This  assessment  is  not  consistent  with  a  catastrophic  brain  injury  and  he  appeared 
unchanged neurologically from his condition prior to being intubated overnight.  

  Had the surgical and anaesthetic team known of the extent of the critical incident of 5 June, 
the operation would have been delayed and further tests and assessments undertaken. The 
anaesthetic team may have opted for elective tracheostomy if the full circumstances of the 
critical incident of 5 June 2022 had been known. An elective tracheostomy would have led 
to a different outcome because it would have avoided the complications that ensued from 
the attempted airway exchange.  

The decision to progress to surgical fixation of Mr Jacka’s thoracic spinal injuries was made by the 
surgical team in consultation with the Intensive Care team and in the knowledge that he had been 
intubated  for  respiratory  failure  early  on  the  5th  June.  He  had  an  appropriate  clinical  neurological 
assessment  during  the  daytime  on  the  5th  June  and was  demonstrated  to  be  unchanged  following 
intubation.  No  other  investigations  were  deemed  necessary  pre-operatively  by  the  surgical  or 
Intensive Care teams. 

Given the severity of Mr Jacka’s injuries, it is likely that a tracheostomy would have been performed 
at  some  stage  during  his  treatment,  however  it  was  not  indicated  prior  to  his  spinal  surgery. 
Tracheostomy insertion carries significant risks, especially in the context of recent cervical spine injury, 
and a newly sited surgical tracheostomy would have represented a higher risk of airway displacement 
during prone spinal surgery than an oral endotracheal tube. These factors had been considered on the 
5th June 2022 as part of the decision to proceed with spinal fixation surgery first. 

 

I note the NHS Investigator and the Investigatory Panel both recommended that action is 
required for the handover of complex patients. The panel recommended as follows: More 
robust and formalised handover of complex patients before transfer to theatre, to include 
review of airway management, cardiopulmonary status, potential avenues of deterioration 
and any significant events during admission. 

  The Trust had chosen not to accept this recommendation but at the time the Trust made that 

decision it was not aware of the extent and significance of the error of omission.  

A review of the current practice for reviewing and handing over patients who require transfer from 
the Intensive Care Unit to the operating theatre has been undertaken. Currently patients are reviewed 
by the surgical and anaesthetic teams pre-operatively and information is collected and documented 
by the anaesthetic team using a structured Pre-operative Anaesthetic Assessment chart in keeping 
with  standard  procedures  across  the  Trust.  The  anaesthetic  team  assess  the  patient  and 
examine/record  relevant 
information  relating  to  the  patient’s  history,  airway  assessment, 
cardiorespiratory  system,  and  any  diagnostic  tests  and  results.  The  pre-operative  assessment  is 
undertaken to formulate a clear anaesthetic plan, but also provides an opportunity to seek additional 
information, optimise the patient if required, and consider if the surgery is safe to proceed. Members 
of the Intensive Care Medical team are present on the Intensive Care Unit 24 hours a day and can 
provide additional information as required. Once the patient has been reviewed by the anaesthetic 
and surgical team, information relating to the patient, as well as the surgical and anaesthetic plan is 
shared and discussed  at the theatre brief prior to the start of the operating list.  

The Trust has an existing process for the handover of postoperative patients to the intensive care Unit 
(appendix  1),  and  this  has  proved  beneficial  in  promoting  meaningful  discussion  between  senior 

 
 
 
 
 
 
 
 decision  makers,  as  well  as  improving  the  quality  of  information  that  is  received.  The  Trust  is 
committed to ensuring that the quality of handovers is as robust as possible given the well evidenced 
risks, and therefore the following actions have been agreed. 

Action 1 (due to be completed by the 29th February 2024): The intensive care and anaesthetic 
department  will  work  together  to  create  a  preoperative  handover  checklist  (similar  to  the 
postoperative handover checklist in appendix 1) which will help ensure that the anaesthetic 
team  collecting  the  patient  has  considered  all  things  that  are  likely  to  be  relevant  to  the 
patients ongoing care and treatment. This will include airway concerns, allergies, medications, 
clotting  and  blood  products  for  example.    This  checklist  would  help  support  meaningful 
discussion between senior decision makers in complex patients. 

I hope that this response provides some reassurance that we have fully explored the concerns raised, 
and that we are committed to taking the necessary steps to improve the safety of our services.  

Yours sincerely, 

Deputy Medical Director 

 
 
 
 
 
 Appendix 1 – Postoperative Intensive Care Handover