The TracMan trial – a multicentre randomised trial of early vs late tracheostomy in ICU patients – has been published, showing no difference in the primary outcome of mortality.
A review of the trial is posted on the excellent PulmCCM blog:
There was no proven difference between groups in 30-day mortality (30.8% early vs. 31.5% late, primary outcome), nor in any other outcome including 2-year mortality.
Patients getting early tracheostomies required fewer days of sedation, and there was a suggestion of a reduction of -1.7 ventilator days with early trach (mean 13.6 days vs 15.2 days, p=0.06). However, ICU stays were exactly equal at a median 13 days.
Also, 7% of patients had significant bleeding attributed to their tracheostomies (defined as needing IV fluids or another intervention); this amounted to 11 patients in the early group and 8 in the late group.
PulmCCM is an excellent free resource that will deliver critical care updates to your inbox. It has a number of other useful features, like free board review questions – highly recommended!
Effect of early vs late tracheostomy placement on survival in patients receiving mechanical ventilation: the TracMan randomized trial
JAMA. 2013 May 22;309(20):2121-9
IMPORTANCE: Tracheostomy is a widely used intervention in adult critical care units. There is little evidence to guide clinicians regarding the optimal timing for this procedure.
OBJECTIVE: To test whether early vs late tracheostomy would be associated with lower mortality in adult patients requiring mechanical ventilation in critical care units.
DESIGN AND SETTING: An open multicentered randomized clinical trial conducted between 2004 and 2011 involving 70 adult general and 2 cardiothoracic critical care units in 13 university and 59 nonuniversity hospitals in the United Kingdom.
PARTICIPANTS: Of 1032 eligible patients, 909 adult patients breathing with the aid of mechanical ventilation for less than 4 days and identified by the treating physician as likely to require at least 7 more days of mechanical ventilation.
INTERVENTIONS: Patients were randomized 1:1 to early tracheostomy (within 4 days) or late tracheostomy (after 10 days if still indicated).
MAIN OUTCOMES AND MEASURES: The primary outcome measure was 30-day mortality and the analysis was by intention to treat.
RESULTS: Of the 455 patients assigned to early tracheostomy, 91.9% (95% CI, 89.0%-94.1%) received a tracheostomy and of 454 assigned to late tracheostomy, 44.9% (95% CI, 40.4%-49.5%) received a tracheostomy. All-cause mortality 30 days after randomization was 30.8% (95% CI, 26.7%-35.2%) in the early and 31.5% (95% CI, 27.3%-35.9%) in the late group (absolute risk reduction for early vs late, 0.7%; 95% CI, -5.4% to 6.7%). Two-year mortality was 51.0% (95% CI, 46.4%-55.6%) in the early and 53.7% (95% CI, 49.1%-58.3%) in the late group (P = .74). Median critical care unit length of stay in survivors was 13.0 days in the early and 13.1 days in the late group (P = .74). Tracheostomy-related complications were reported for 6.3% (95% CI, 4.6%-8.5%) of patients (5.5% in the early group, 7.8% in the late group).
CONCLUSIONS AND RELEVANCE: For patients breathing with the aid of mechanical ventilation treated in adult critical care units in the United Kingdom, tracheostomy within 4 days of critical care admission was not associated with an improvement in 30-day mortality or other important secondary outcomes. The ability of clinicians to predict which patients required extended ventilatory support was limited.
Adapted from the UK Intensive Care Society’s ‘Standards for the care of adult patients with a temporary tracheostomy‘
Bleeding from an established tracheostomy (ie. ‘late bleeding’, as to opposed to peri-operative bleeding that is more common and often benign) may occur because of erosion of blood vessels in and around the stoma site. This is more likely if there has been infection of the stoma site. Such bleeding may settle with conservative management. More worryingly, however, is the prospect of such bleeding being the result of erosion of a major artery in the root of the neck where there has been pressure from the tracheostomy tube itself or the cuff tube. Most commonly, this erosion occurs into the right brachiocephalic artery (also known as the innominate artery), resulting in a tracheo-innominate artery fistula. This situation may be heralded in the preceding hours by a small, apparently insignificant, sentinel bleed. Bleeding from such a fistula will be massive. THIS IS A LIFE-THREATENING EMERGENCY and so decisions need to be rapidly made.
- Call for help– senior medical and nursing staff, other health professionals with tracheostomy care skills (e.g. respiratory therapist, physiotherapist).
- Clear airway – blood clots may need to be suctioned.
- Replace blood products as required
- Bleeding may be temporarily reduced or stopped by applying finger pressure to the root of the neck in the sternal notch, or by inflating the tracheostomy tube cuff (if present) with a 50ml syringe of air. This inflation should be done slowly and steadily to inflate the balloon to a maximum volume without bursting it. Depending on the type and size of the tracheostomy tube this may be anywhere between 10 and 35 ml.
- Urgent referral for surgical exploration must now be made, if not already done so. In addition to an ENT or maxillofacial surgeon, it may be necessary to get help from a vascular surgeon. Sometimes, the damage can only be repaired utilising cardio-pulmonary bypass, and so a cardiothoracic surgeon may also be needed to help.
- Consider palliation – it is well recognised that fatalities occur in this situation, and that this may be the mode of death for some patients with head and neck cancers
The National Tracheostomy Safety Project at www.tracheostomy.org.uk in the UK aims to allow patients with tracheostomies or laryngectomies to be safely cared for in hospitals.
The site contains a wealth of educational resources of use to the critical care practitioner. For example, have you thought about what do with a laryngectomy patient who presents with dyspnoea, or even apnoea? Remember that although applying oxygen to the face & neck is a default emergency action for all patients with a tracheostomy, these patients cannot be intubated and ventilated through the normal oral route since their tracheostomy is an end stoma – it does not communicate with the mouth:
Compare this with the algorithm for other patients with a tracheostomy, in whom attempts to oxygenate and ventilate, including intubation, can be made in an emergency either from the ‘top end’ (mouth) or via the stoma:
There are also a number of multimedia resources and a link to the UK Intensive Care Society’s Tracheostomy Guidelines
In ICU, Percutaneous Dilatational Tracheostomy (PDT) is often performed to facilitate weaning from mechanical ventilation, reduce anatomical dead space, avoid laryngeal injury and aid in management of tracheobronchial and pulmonary secretions.
There is still controversy over optimal timing and case selection for PDT. Some organisations have helped to clarify the situation for practicing intensivists.
In 2010 the Australian and New Zealand Intensive Care Society (ANZICS) produced its Percutaneous Dilatational Tracheostomy Consensus Statement, to represent best current practice in Australia and New Zealand.
This can be downloaded from here.
Level 1 evidence is great, but for useful tips that can add options to your resuscitation toolbox there are some great finds in journal letters pages.
Try this one: An apneoic patient requires assisted ventilation in your resuscitation room. Bag-mask ventilation is ineffective. You then notice a mature tracheostomy at the same time that you’re told he had a laryngectomy. How would you ventilate him?
The obvious answer is to intubate the stoma with a size 6.0 tracheal tube or a tracheostomy tube if you have one. However prior to that you could bag-‘mask’ ventilate with a size 2 laryngeal mask airway applied to the stoma, holding the cuff in place with pressure through an index finger.
Such a technique is desribed in the context of an elective anaesthesia case in this month’s Anaesthesia. The LMA cuff provided an effective seal around the stoma, thereby allowing leak-free ventilation.
Stoma ventilation using a paediatric facemask is another option.
Tracheostomy ventilation using a laryngeal mask as a ‘bridge to extubation’