Helen Patton

From Ben Gummer MP
& : Parliamentary Under Secretary of State for Care Quality

Department Richmond House

of Health dg ie

POC 1031054 Siig 2S
Tel: 020 7210 4850

Ms Karen L Dilks LL.B

HM Senior Coroner

Coroner’s Court 01 JUL 2016

Civic Centre

Barras Bridge

Newcastle Upon Tyne

NEI 8PS “~*
as June 2016

Thank you for your letter of 20" April 2016, following the inquest into the death of
Helen Patton. I was sorry to hear of Mrs Patton’s death and wish to extend my sincere
condolences to her family.

Your report concerns the performance of mini Tracheostomy procedures. You raise a
number of points:

e the continuing risk of mortality, where mini tracheostomy procedures are not
undertaken within theatre conditions or ultrasound guided;

e that mini tracheostomy procedure is undertaken regularly on a national level
without ultrasound guidance or in theatre conditions;

e the absence of any national guidance in respect of mini tracheostomy
procedures to minimise the risks associated with them, particularly the risks of
conducting such procedures outside of an operating theatre and without
ultrasound guidance.

I have consulted the Royal College of Surgeons (RCS), the Faculty of Intensive Care
Medicine (FICM) and the Royal College of Anaesthetists (RCOA) in preparation of
this response.

FICM and RCOA have reviewed your Regulation 28 report and provided a joint
response to the issues you raise (enclosed). They confirm that routine use of
ultrasound is not mandated prior to mini tracheostomy as it is not currently feasible to
do so for a number of reasons. The Intensive Care Society and FICM are developing
ways to standardise ultrasound access training in order to make it more accessible.

However, FICM and RCOA point out that ultrasound is largely limited to pre-
procedure planning and anatomic landmark identification as the size and shape of
most available probes makes real-time scanning impractical. They also point out that
bleeding can occur with or without prior use of ultrasound.

With regard to carrying out a mini tracheostomy procedure, FICM and RCOA confirm
that an appropriately equipped critical care unit is and would be a suitable setting.

The reasoning and evidence for these views is in their full reply.

Various reviews and professional guidance have been published for England
concerning the safe use of Tracheostomy and the care of patients undergoing this
treatment:

e The National Institute for Health and Care Excellence (NICE) has produced
interventional procedure guidance [IPG462] on Translaryngeal tracheostomy
which makes recommendations on the safety and efficacy of this procedure.
This guidance acknowledges that Tracheostomy is commonly carried out for
patients in intensive care and although this may be performed surgically,
anaesthetists and intensive care physicians usually perform the procedure using
a percutaneous technique under endoscopic guidance. NICE reports that the
translaryngeal tracheostomy technique may lead to lower rates of bleeding,
trauma and infection to the tissues surrounding the insertion area, compared
with surgical and other percutaneous techniques. It may also avoid the risk of
damage to the posterior wall of the trachea and tracheal rings, because of a lack
of external compression during insertion.

e The National Confidential Enquiry into Patient Outcome and Death (NCEPOD)
has published a report, On the Right Trach? (2014). The report reviews the care
received by patients who underwent a tracheostomy and includes
comprehensive key findings and recommendations. As a result of the NCEPOD
report, the National Tracheostomy Safety Project (NTSP) published a
comprehensive best practice guide, Comprehensive Tracheostomy Care - the
NTSP Manual, in 2014.

e In addition, the Royal College of Anaesthetists (RCOA) has published
Anaesthesia services for head and neck surgery 2015. These guidelines include
advice on support and care for tracheostomy patients and recommend that all
Trusts should have a protocol and mandatory training for tracheostomy care.

<2 pel

Department
of Health

All of these guidelines were developed following consideration of the risks associated
with tracheostomy procedures and therefore incorporate best practice advice and
support. They all clearly indicate that it is routine practice to carry out an emergency
tracheostomy in a critical care unit. What is of vital importance however is the level of
competency of the individual carrying out the procedure, the availability of senior
support and access to appropriate resuscitation equipment.

I hope that this reply is helpful and I am grateful to you for bringing the circumstances
of Mrs Patton’s death to my attention.

Ong “AS,

BEN GUMMER

Regulation 28 Report to prevent future deaths 
Helen Elizabeth Patton 
Comments from the Faculty of Intensive Care Medicine and Royal College of Anaesthetists 

The Faculty of Intensive Care Medicine and Royal College of Anaesthetists have reviewed the 
information received regarding the above Regulation 28 report. The Faculty and College noted that the 
clinical details were limited. Mrs Patton died from exsanguination either during or after a 
minitracheostomy was inserted for removal of secretions on an intensive care unit.  

It was not stated who inserted the device or their level of experience or training in this or other modes 
of tracheostomy or front of neck airway (FONA). It is not stated at what level of the trachea this was 
inserted (or intended to be inserted) e.g. cricothyroidotomy or tracheostomy. It is not stated if the 
patient’s condition rendered the procedure to be more difficult (obesity, short neck, limited neck 
movements) or more prone to complications (e.g. coagulopathy, anticoagulants, antiplatelet drugs, 
recent thoracic surgery).  There is therefore inadequate data to answer this question definitively.  

However, based on data from percutaneous tracheostomy, which is likely to be a higher risk procedure 
than minitracheostomy, routine use of ultrasound is not mandated prior to minitracheostomy and an 
appropriately equipped critical care unit would be a suitable setting, as timely management of potential 
complications can be undertaken (i.e. immediate intubation and management of bleeding).  The Faculty 
and College would support the NCEPOD recommendation that insertion of any device in the front of the 
neck for access to the airway is classed as a surgical procedure. Appropriate patient assessment and 
planning should have taken place if the procedure was not urgent. As this is a surgical procedure it 
should have been undertaken by someone who was capable of weighing up all options and issues at the 
site, with responsibility for ensuring that appropriate support was available if needed and able to 
manage any complications (i.e. haemorrhage). 

The Faculty and College would recommend: 

imaging for patients who have or are expected to have complications or abnormal anatomy.  
the presence of, or access to, an ENT specialist in these cases.   

 
 
  a Seldinger technique as the default technique for minitracheostomy insertion. This will reduce 

 

 

the risk of bleeding at insertion. 
the cricothyroidotomy should be the default insertion site, which will reduce the risk of bleeding 
at insertion. 
that as the current evidence for minitracheostomy is limited, its use should be limited to specific 
circumstances. 

It is not currently feasible to mandate the use of ultrasound for invasive airway access for a number of 
reasons. The Intensive Care Society and the Faculty of Intensive Care Medicine are developing ways to 
standardise ultrasound access training in order to make it more accessible.  It should be noted that 
ultrasound is largely limited to pre-procedure planning and landmark identification as the footprint of 

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 most available probes makes real-time scanning impractical.  It should also be noted that bleeding can 
occur with or without prior use of ultrasound. 

Background and rationale 

A minitracheostomy (Mini Trach) is a narrow uncuffed plastic tube (4mm internal diameter, 5.4m 
external diameter) intended to be placed through the cricothyroid membrane to ’access’ the trachea 
and to enable clearance of secretions.  

The ‘mini-trach’ and mini-trach II’ devices are designed to be place in the cricothyroid membrane but 
sub-cricoid use has been described (van Heurn LW, van Geffen GJ, Brink PR.  Percutaneous subcricoid 
minitracheostomy: report of 50 procedures. Ann Thorac Surg. 1995; 59: 707-9.). 

It has been used to assist sputum clearance most prominently after or during critical care admission and 
after thoracic surgery. It is likely its use has waned in the last decade or so. Its value compared to other 
techniques for sputum clearance (delayed extubation, tracheostomy, physiotherapy techniques) is likely 
unproven. In some parts of the country the use of mini tracheostomy in an ICU setting is rarely if ever 
used while in others the practice is more common. 

In general a minitracheostomy will only be inserted in patients who have a high risk of sputum retention 
and respiratory failure. These are, by definition, a group of patients who are likely to have a high 
mortality in hospital with or without a minitracheostomy. 

A minitracheostomy is most frequently inserted by an intensivist or an anaesthetist. In the past, ward 
doctors and occasionally physiotherapists have inserted them. Use by a surgeon outside elective 
prophylactic insertion for thoracic surgery would be less common.  

Insertion is most commonly performed on an ICU/HDU (critical care area) but on occasions on a ward. 
The technique is usually performed in an awake patient using local anaesthetic. Reported and potential 
complications include failure of placement, misplacement (subcutaneous, oesophageal and pleural 
placement), granuloma formation, pneumothorax, oesophageal perforation, thyroid abscess and 
bleeding.  

Ultrasound may be used to assist ‘front of neck airway (FONA) procedures. It may improve identification 
of the trachea, of the level of insertion andidentify blood vessels. This is an emerging technique for use 
in airway management and cannot be considered routine practice for any FONA. We are not aware of 
any data on its use for minitracheostomy.  

The only comparative data would be for percutaneous tracheostomy on ICU. The NCEPOD report ‘On 
The Right Trach’ in 2014 estimates 12,000 tracheostomies are performed each year in the UK of which 
70% are percutaneous procedures. While the report does not specify, almost all of these will be 
performed in a critical care setting rather than in an operating theatre. Tracheostomy – because of the 
lower location of the FONA, because of the size of the tube used, and because of the clinical state of the 
patients on whom it is performed would be anticipated to be a higher risk procedure for bleeding than 
minitracheostomy performed at the cricothyroid level. 

NCEPOD states “…The use of real time ultrasound guidance has been advocated to assist in avoiding 
damage to vascular structures and to prevent misplacement of the tracheostomy tube. However, in a 
recent systematic review, the evidence of benefit over traditional landmark-guided techniques was 
limited (Rudas M and Seppelt I. Safety and efficacy of ultrasonography before and during percutaneous 

2 

 
 
 
 
 
 
 
 
 
 
 
 
 
 dilatational tracheostomy in adult patients: a systematic review. Crit Care Resusc 2012; 14: 297-301). In 
the current study, ultrasound was used in 484/1471 (32.9%) of patients.”  

The use of ultrasound (for percutaneous tracheostomy or open tracheostomy) is not included in any 
recommendation made by the NCEPOD report.  

This report also noted that in percutaneous procedures “Although immediate complications were 
uncommon, they still occurred in 81/1482 (5.5%) patients. The most common complication was minor 
haemorrhage (46 cases).” (ie 3%). 

The NAP4 report in 2011 collated data on major complications of airway management in the UK. 
Complications of tracheostomy in ICU were a significant contributor to airway related mortality but 
bleeding at tracheostomy was not (
 Major complications of 
airway management in the UK: results of the 4th National Audit Project of the Royal College of 
Anaesthetists and the Difficult Airway Society. Part 2 Intensive Care and Emergency Department.. British 
Journal of Anaesthesia 2011; 106: 632-42). 

Bleeding from a tracheostomy may occur at insertion or after some delay. Performance of a FONA or 
tracheostomy procedure in an operating theatre does not preclude subsequent bleeding, including life-
threatening bleeding.  

3