Prevention of Future Deaths reports · 2017

Peter Saint

Regulation 28 report to prevent future deaths, reference 2017-0404, written 17 Nov 2017. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.

Date of report17 Nov 2017
Reference2017-0404
DeceasedPeter Saint
CoronerSean Horstead
Coroner areaCambridgeshire and Peterborough
CategoryHospital Death (Clinical Procedures and medical management) related deaths
Sourcejudiciary.uk record · original PDF
Responses published3

The report

Text recovered by OCR from a scanned PDF. OCR is imperfect: check anything you rely on against the source PDF. Reproduced verbatim, including the scan's own layout.

Regulation 28: REPORT TO PREVENT FUTURE DEATHS (1)

NOTE: This from is to be used after an inquest.

REGULATION 28 REPORT TO PREVENT DEATHS
THIS REPORT IS BEING SENT TO:

Simon Stevens, Chief Executive Officer, NHS England
Medical Director, North West Anglia NHS Foundation Trust
Royal College of Anaesthetists

The Difficult Airway Society

bhWN Pe

1 CORONER

1am Sean Horstead, Assistant Coroner for the area of Cambridgeshire and Peterborough.

2 CORONER’S LEGAL POWERS

I make this report under paragraph 7, Schedule 5, of the Coroners and Justice Act 2009 and regulations 28 and
29 of the Coroners (Investigations) Regulations 2013.

3 INVESTIGATION and INQUEST

On 07/07/2016 an investigation was commenced into the death of Peter lan SAINT aged 71. The investigation
concluded at the end of the inquest on 23/10/2017. The conclusion of the inquest was:

Medical cause of death:
1a Hypoxic / ischaemic brain damage following oesophageal placement of endotracheal tube;
1b General anaesthesia for knee replacement surgery.

There was a narrative conclusion that Mr Saint “died from extensive hypoxic brain damage sustained when
deprived of effective lung ventilation after an endotracheal tube was located in his oesophagus for a period of
some 25 minutes whilst under general anaesthetic for routine knee replacement surgery.”

4 CIRCUMSTANCES OF THE DEATH

On the 23 June 2016 Peter Saint, a 71 year old man was admitted to Hinchingbrooke Hospital,
Cambridgeshire for routine elective knee replacement surgery. General anaesthesia was administered at
around 15.00 hours. Between 15.40 and 15.45 hours there was a progressive fall in Mr Saint’s arterial oxygen
saturation and an increase in ventilation pressure. At the removal of the laryngeal mask airway gastric fluid
was expelled; the operating table was tilted head down, suction applied and an i-Gel airway deployed. At
around 16.00 hours the i-Gel was replaced by an endotracheal intubation tube. However, this was inserted
into Mr Saint’s oesophagus rather than his trachea. The oesophageal placement was not identified by the
three anaesthetists present (including two consultants), notwithstanding the fact that an experienced Senior
Operating Department Practitioner specifically raising his concerns that the intubation tube was misplaced by
reference to the capnography which indicated an absence of a CO end tidal wave on the monitor and the
apparent “timpanic” distension of the patient’s stomach. At or around 16.04 hours Mr Saint suffered a cardiac
arrest and chest compressions were commenced. The oesophageal placement of the endotracheal tube was
only confirmed at or around 16.25 hours and the intubation tube was relocated in the trachea.

For a period of around 38 minutes, from approximately 15.47 hours until 16.25 hours Mr Saint received no
effective lung ventilation. For some 25 minutes of that 38 minute period the endotracheal intubation tube

was incorrectly located in Mr Saint’s oesophagus. Throughout, confirmation that Mr Saint was receiving no
effective lung ventilation was displayed on the monitoring equipment as an absence of any CO2 end tidal wave
consistent with effective lung ventilation, together with a digital read out of ‘zero’ immediately adjacent to the
CO2 end tidal wave display.

Mr Saint was transferred to the Intensive Care Unit (ICU) of Hinchingbrooke Hospital where he died at 13.44
hours on 28" June 2016.

5 CORONER’S CONCERNS

The MATTERS OF CONCERNS are as follows:

(a)

During the course of evidence [ heard that an (admitted) “misunderstanding of physiology” led the
lead consultant anaesthetist involved in the treatment of Mr Saint to conclude that whilst the patient
was receiving appropriate chest compressions during resuscitation efforts, the capnography indicating
an absence of a CO2 end tidal wave on the monitor could be explained by the fact that Mr Saint was
in cardiac arrest. This was a mistake since exhaled CO2 can virtually always be observed during
cardiac arrest with correctly applied compressions and lung ventilation. The clear expert evidence
was that, discounting a technical problem with the monitoring equipment (not applicable here), the
absence of a proper CO2 end tidal wave could only in the most exceptional circumstances be
accounted for by anything other than oesophageal intubation and certainly not by cardiac arrest.
Further, the expert evidence indicated that such a “misunderstanding of the physiology” is one that is
known to be shared by other anaesthetists.

This is of particular concern given that the issue was specifically addressed in the 4" National Audit
Project (NAP4) of the Royal College of Anaesthetists and the Difficult Airway Society: ‘Major
Complications in Airway Management in the UK’ Report and Findings as long ago as March 2011 (at
page 101):

“Unsurprisingly, the outcome of unrecognised oesophageal intubation is usually very poor indeed.
Tracheal intubation in theatre is nowadays carried out in the presence of a trained assistant and a
tested and functioning capnograph. The latter, in particular, means that unrecognised oesophageal
intubation rarely occurs in the theatre environment. In contrast to the ICU and emergency department
cases where capnography was not used, in the cases of oesophageal intubation during anaesthesia
capnography was in use during the event. The event progressed due to failure to correctly interpret
capnography in the face of situations of peri-arrest or cardiac arrest. Capnography can become
difficult to interpret during low cardiac output states and in cardiac arrest. However a flat line is not
usual and even in cardiac arrest, during CPR, carbon dioxide is produced leading to an attenuated
but visible capnography trace (see Figure 1). A completely flat capnograph in any circumstances
should immediately raise the possibility that the tracheal tube is not in the trachea, or is obstructed.
Active measures should be undertaken to confirm or exclude these diagnoses. Clinical signs are
unreliable in these circumstances and it is recognised that oesophageal intubation may present both
after apparent normal auscultation of the lungs and as cardiovascular collapse.” (Emphasis added).

The Report made the following recommendation:

“Training of all clinical staff who may intubate patients should include interpretation of capnography.
Teaching should include recognition of the abnormal (but not flat) capnography trace during low
cardiac output states and during cardiopulmonary resuscitation.”(page 103).

| am concerned that the evidence in this case, including the expert evidence, established that
notwithstanding the findings and recommendations of the 2011 NAP4 there is a continuing failure to
ensure that capnography is sufficiently understood and utilised by all clinical staff who may intubate
patients.

The evidence heard, including the expert evidence, confirmed that an integra! part of the process of
intubating a patient requires that the anaesthetist, following the placement of the intubation tube

into the patient, observes the capnography for a period of up to 15 to 20 seconds to ensure that a
“proper CO2 end tidal wave” can be detected; failure to do so would be a “fundamental and basic
error” and a “serious error”. | am concerned that this procedure was not followed by either the lead
consultant anaesthetist in this case or the anaesthetists who attended to assist him. The expert
evidence indicated a lack of widespread, regular, mandatory on-going training for anaesthetists in
drills dealing with crisis situations potentially facing an anaesthetic team particularly in relation to the
issues of “task fixation” and “confirmatory bias”, and that such training woutd be beneficial.

6 ACTION SHOULD BE TAKEN

In my opinion action should be taken to prevent future deaths and | believe you (and/or your organisation)
have the power to take such action.

7 YOUR RESPONSE

You are under a duty to respond to this report within 56 days of the date of this report,
namely by 12" January 2018. |, the coroner, may extend the period.

Your response must contain details of action taken or proposed to be taken, setting out the timetable for
action. Otherwise you must explain why no action is proposed.

8 COPIES and PUBLICATION

| have sent a copy of my report to the Chief Coroner and to the following Interested Persons:

HE brother of the Deceased);

The Executors of Mr Saint’s estate;

| am also under a duty to send the Chief Coroner a copy of your response.

The Chief Coroner may publish either or both in a complete or redacted or summary form. He may send a
copy of this report to any person who he believes may find it useful or of interest. You may make
representations to me, the coroner, at the time of your response about the release or the publication of your
response by the Chief Coroner.

9

Signed:

Sean Horstead Assistant Coroner for Cambridgeshire & Peterborough

Dated: 17.11.2017

Responses

3 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.

Response from North West Anglia NHS Trust (PDF)
NHS

North West Anglia
NHS Foundation Trust

Peterborough City Hospital
Dr Kanchan Rege ° Bretton Gate

Medical Director, Responsible Officer & Consultant Haematologist Peterborough

ea - . i ae PE3 9GZ

Tel: 01733 678000

Po o_o

12 January 2018

Mr Sean Horstead

Assistant Coroner for Cambridgeshire and Peterborough
Lawrence Court

Princes Street

Huntingdon

PE29 3PA

Dear Mr Horstead
Regulation 28: Report to prevent future deaths

Thank you for the Regulation 28 letter received in November 2017 in relation to the death of Mr Peter
Saint. May | take this opportunity on behalf of North West Anglia NHS Foundation Trust to assure you
that we acknowledge the shortcomings in our care of Mr Saint and fully appreciate your concerns. Your
letter has been circulated amongst the Anaesthetic clinical and leadership complement at the entire
Trust, that is to say Hinchingbrooke and Peterborough City Hospitals.

An action plan has been developed to tackle not only the technical aspects which were identified in the
inquest, but also the wider human factors and cultural issues that were exposed. The points below set
out our proposed action plan, with a timescale for completion by the end of March 2018.

1. Simulation training

All members of the anaesthetic department at Hinchingbrooke are to participate in an airway simulation
course at a high fidelity simulation centre. We have identified a suitable course and are in the process
of planning training with the course provider. It is a one day course for anaesthetist-ODP teams that
combines human factors with airway technical skills. It includes interactive team training, simulation,
error avoidance strategy, airway-technical skills, human factors in crisis management and practical
briefing/debriefing skills. Due to the logistics of having all of the anaesthetists attending external
training, while continuing to staff the service for patients it will be necessary to run the course on
multiple dates. This course will address the specific issues regarding the use and interpretation of
capnography that were raised in your letter.

2. Human factors training

Aconsultant obstetrician with expertise in Human Factors has been commissioned to provide training to
anaesthetists and theatre staff. Multidisciplinary teams, consisting of consultant anaesthetists, operating
department practitioners and theatre nurses, are being recruited. These teams will be trained to train,
following which they will deliver training to other staff on a rolling basis throughout the year. A steering
group, composed of the Associate Divisional Director (consultant anaesthetist), matrons and theatre

managers, will meet 3-monthly to consider recommendations from the trainer group. This will address
the non-technical issues that were involved in causing the death.

3. SCORE cultural survey (Safety, Communication, Operational Reliability & Engagement)

This survey has been undertaken among six teams at Hinchingbrooke, including anaesthetists and
theatre staff. Feedback occurs in a controlled environment that provides a safe forum for staff to discuss
issues, in the absence of managers and management grade clinicians.

The feedback session for anaesthetists took place on 12 December 2017. The process for collating
comments is currently underway. When this is complete it will generate a further action plan for
managers. This will address wider organisational issues that may have contributed indirectly to the
circumstances that led to the death.

| would add that since the unfortunate event of June 2016, many substantive appointments have been
made to the cadre of Consultant Anaesthetists at Hinchingbrooke Hospital to replace locum staff. In
addition, there is now circulation of colleagues between Peterborough and Hinchingbrooke Hospitals
delivering clinical sessions at both sites, allowing a greater pool of mutual support, mentorship, training
and access to best practice.

| once again assure you that | take this issue extremely seriously and will do my upmost to ensure
similar events never happening again.

Kind regards.

Yours sincerely
VN alll
i

Kanchan Rege
Medical Director and Responsible Officer
Response from Rcoa (PDF)
RCSA uy Difficult Ai rway Society THE ASSOCIATION OF ANAESTHETISTS

Royal College of Anaesthetists of Great Britain & Ireland

12! January 2018
Mr. Sean Horstead, Assistant Coroner for Cambridgeshire and Peterborough

Dear Mr. Horstead,

Regulation 28 Report to Prevent Future Deaths following the inquest into the death of Peter lan
SAINT

Thank you for giving the Royal College of Anaesthetists (RCoA) the opportunity to respond to
your Regulation 28 Report. The RCOA has collaborated with the Association of Anaesthetists
of Great Britain and Ireland (AAGBI) and the Difficult Airway Society (DAS) in preparing this
response.

Capnography

We are concerned that despite the emphasis placed upon the continuing presence of
exhaled carbon dioxide during resuscitation from cardiac arrest in resources such as NAP4
and the Advanced Life Support programme run by the Resuscitation Council UK, there are
still clinicians holding senior positions in anaesthesia in the NHS who are unaware of this
important fact. We will seek to address this issue by:

° Bringing this to the attention of all trainees in anaesthesia in the UK, to all Fellows and
members of the RCOA, to all members of the AAGBI and all members of the DAS - and
thereby to the overwhelming majority of practising anaesthetists in the NHS — by
publishing an article on this subject in the Patient Safety Update published quarterly by
the Safe Anaesthesia Liaison Group (SALG): h!!os://www rcoa ac uk/salg, by
highlighting this issue in a “Safety Matters” article in Anaesthesia News (a publication
that is circulated to over 11,000 AAGBI members) and in the DAS newsletter.

° Bringing this to the attention of RCoA and DAS Airway Leads (AWLs), present in every
NHS Trust/Board, at the next national AWL meeting inviting feedback on areas for
improving training.

° Asking those charged with providing the RCoA's comprehensive online educational
programme (e-Learning for Anaesthesia) to consider highlighting this issue in sessions on
intubation, capnography and resuscitation.

Human factors and teamwork

The RCoA agrees with the expert who advised you during the inquest that there is a lack of
widespread, regular, mandatory training for clinicians in human factors and crisis drills. The
RCOA supports such education, running a regular programme of training in “Non-Technical
Skills" https://www.rcoa,ac.uk/sites/default/files/24_11_17 0.odf and a working group
devoted to providing guidance on simulation of clinical crises, while including a requirement
for human factors training in its exam curricula and its Guidelines for the Provision of
Anaesthesia Services. We note that regular human factors and teamwork training for
multidisciplinary groups is a requirement of the recently published National Safety Standards
for Invasive Procedures (NatSSIPs), which are being introduced in England and Wales. The
RCOA cannot mandate multidisciplinary training in NHS working environments, it is the
responsibility of health organisations to facilitate this in terms of time and resources, but the
RCoA will take the following actions to support this development:

. Asking the RCoA's Simulation Working Group to consider creating guidance on how
departments of anaesthesia can introduce regular crisis simulation for operating
theatre teams.

ayy
RCOA Ge Difficult Airway Society THE ASSOCIATION OF ANAESTHETISTS
Royal College of Anaesthetists oe of Great Britain & Ireland

° Working with the AAGBI to promote regular multidisciplinary crisis simulation when it
publishes its forthcoming Quick Reference Handbook, a series of national guidance
documents on the management of emergency situations in anaesthetic practice. This
handbook emphasises the importance of multidisciplinary crisis practice and the
significance of the absence of ETCO2 in cardiac arrest.

e Working with the DAS, who have set up an expert working group looking specifically at
human factors in ainway management, to address the non-technical aspects of the
management of tracheal intubation and difficult airways.

| hope that these actions will satisfy you that the named organisations are taking appropriate
steps to ensure that anaesthetists are aware of these issues and that the circumstances that
led to the death of Mr Saint are therefore less likely to occur again.

| would be happy to respond to any questions that you might have.

Yours Sincerely

-o i ae
pC

Clinical Quality Adviser, RCoA President, AAGBI President, DAS
Response from NHS England (PDF)
Mr Sean Horstead
Assistant Coroner

07 JUN 2018

YEARS
England —si88

Professor Stephen Powis
National Medical Director
Skipton House

80 London Road

SE1 6LH

Senior Coroner's Office
Cambridgeshire & Peterborough
Lawrence Court

Princes Street ; 4" June 2018
Huntingdon
PE29 3PA

Dear Mr Horstead,

Re: Regulation 28 Report to Prevent Future Deaths following an inquest
concerning the death of Peter lan Saint (died 28.06.2016)

Thank you for your Regulation 28 Report to Prevent Future Deaths (“Report”)
dated 17 November 2011 conceming the death of Mr Saint on 28" June 2016.
Firstly, | would like to express my deep condolences to Mr Saint's family. We
would also like to apologise for the late response to your Report, your Report
was not received in time for me to form a response within the 56 days’ timescale.

Your Report concludes Mr Saint's death was a result of extensive hypoxic brain
damage sustained when deprived of effective lung ventilation after an
endotracheal tube was incorrectly located in his oesophagus whilst under general
anaesthetic for routine knee replacement surgery.

Following the inquest you raised concerns in your Report to NHS England
regarding:

a) a failure to understand capnography indications
b) a lack of on-going training for anaesthetists

NHS England is the national commissioning board for the NHS. We set national
NHS priorities, provide direction and share out funds to local areas to deliver
healthcare. Whereas, NHS Improvement has responsibility for overseeing
foundation trusts and NHS trusts to ensure and to hold to account all providers
on quality of care and on financial stability.

As a result, we do not communicate directly with NHS hospital trusts. However,
we have contacted colleagues within the patient safety team at NHS
Improvement who have contacted North West Anglia NHS Foundation Trust
(‘Trust’) directly. The Trust has confirmed that a Serious Incident Investigation
Report has been carried out. They concluded that: ‘endotracheal tubes 1 and 2
were incorrectly placed in the oesophagus rather than the trachea. Contributing

High quality care for all, now and for future generations

to this was the failure to recognise this resulted in prolonged loss of the airway,
oxygenation and subsequent cardiorespiratory arrest and hypoxic brain injury.
The leadership of the cardiac arrest was poorly managed due to loss of
situational awareness and human factors. There was a reliance on the clinical
signs of tube placement rather than on the monitoring equipment and
capnography readings’. We also note that the Trust has contacted the family to
notify them of this investigation.

NHS Improvement has also informed us that further action has been taken
around this matter in that, as of February 2018, a new Never Event - ‘undetected
oesophageal intubation’ - has been included into their Never Event Framework.
The Framework lists out a number of events that are defined as ‘serious
incidents’ as they are deemed preventable as sufficient national guidance does
exist and should be implemented by all healthcare providers. NHS Improvement
is currently developing the national guidance required to support this proposed
new Never Event, working closely with relevant national organisations, including
Royal College of Anaesthetists (“RCoA”), the Association of Anaesthetists of
Great Britain and Ireland (“AAGBI’) and British Association of Paediatric
Nephrology (the Renal Association).

In terms of training, the RCoA’s continuing professional development’ (“CPD”)
does include training on perioperative emergencies (including crisis training);
emergency management and resuscitation; and human factors in anaesthetic
practice. Consultants must undertake CPD training and this is used to assess
revalidation, which every doctor practising medicine in the United Kingdom must
do. We believe that the additional development of national guidance under the
Never Events Framework will further support this.

Thank you for bringing these important patient safety issues to my attention and |
hope the above information has provided you with assurances that NHS England
is taking appropriate action to address your concerns. Please do not hesitate to
contact me should you need any further information.

Yours sincerely,

Professor Stephen Powis
National Medical Director
NHS England

* https: //www.rcoa.ac.uk/system/files/CPDMatrix2015.pdf
High quality care for all, now and for future generations

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