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Early tracheotomy is better than late

Citation/s:
Rumbak MJ et al. A prospective, randomised study comparing early percutaneous dilational tracheotomy to prolonged translaryngeal intubation (delayed tracheotomy) in critically ill medical patients. Crit Care Med 2004; 32: 1689 - 1694

Lead author's name and fax: Rumbak MJ. dmrumcake@aol.com

Three-part Clinical Question: Does early tracheotomy (2 days) in medical intensive care patients projected to require prolonged ventilation improve mortality; incidence of pneumonia and number of ventilator days when compared to delayed tracheotomy (14 days)?
 

Search Terms: (MEDLINE) Tracheotomy (6867 papers); intensive care (43491 papers); prospective study (180328 papers); pneumonia/etiology (9923 papers). Sets combined 2 papers.

The Study: Non-blinded concealed randomised controlled trial with intention-to-treat.

The Study Patients: Intubated medical intensive care patients with acute respiratory failure who were projected to need mechanical ventilation for more than 14 days. Patients were in three intensive care units in the United States. Patients with various contraindications for percutaneous tracheotomy were excluded.

Control group (N = 60; 60 analysed): Control patients underwent standard intensive care with the expectation of proceeding to percutaneous tracheotomy at 10-14 days. Ventilation, weaning and sedation were protocol driven.

Experimental group (N = 60; 60 analysed): These patients proceeded to percutaneous tracheotomy after 48 hours of mechanical ventilation. This was under bronchoscopic control with experienced practitioners. Sedation was stopped 24 hours after the tracheostomy was sited.

The Evidence:

Comments:

1. Do the methods allow accurate testing of the hypothesis?

Yes. However the study compares early versus late tracheotomy, not prolonged trans-laryngeal intubation as suggested in the title.

2. Do the statistical tests correctly test the results to allow differentiation of statistically significant results?

Yes. The study was powered for a 50% reduction in the incidence of pneumonia with a baseline incidence of 50%. Dichotomous variables were assessed with the chi-squared test.

3. Are conclusions valid in light of the results?

Yes, although as commented by the authors, this represents only a specific patient group: medical patients with an admission APACHE II score of >25 and where prolonged ventilation was anticipated. The authors did not state if any medical patients not projected to need prolonged ventilation subsequently proceeded to tracheotomy. The reason for an APACHE II score of 25 was not made clear.

4. Did results get omitted, and why?

No, and analysis was on an intention-to-treat basis

5. Did they suggest areas of further research?

No. Whether outcome difference was due to a sedation effect may be worthy of consideration.

6. Did they make any recommendations based on the results and were they appropriate?

Yes. That the risk / benefit is in favour of early tracheostomy, and this appears to be appropriate.

7. Is the study relevant to my clinical practice?

Largely. Clearly both tracheotomy and prolonged ventilation are pertinent issues on the intensive care unit. Differences in the medical staffing of the intensive care units between the USA and the UK may be relevant; the skills of the resident doctor were not detailed. A lack of a resident anaesthetist may have lead to increased levels of sedation in intubated patients; again this aspect is unclear. The depth of sedation in control patients is unclear except “sedated but arousable” and for the provision of a daily sedation holiday.

8.  What level of evidence does this study represent?

1+

9.  What grade of recommendation can I make on this result alone?

B

10. What grade of recommendation can I make when this study is considered along with other available evidence?

This is the only prospective randomised study of its type.

11. Should I change my practice because of these results?

Yes. It may be reasonable to proceed to early tracheotomy in this group of patients. The study demonstrates that early tracheotomy, in experienced hands is safe, and leads to a marked improvement in outcome. It also challenges the current practice of performing tracheotomy at 10-14 days. The accompanying editorial points out that the current 10-14 days practice is not evidence based.

12. Should I audit my current practice because of these results?

Yes. The timing of tracheotomy for various patient groups and also, the early use of tracheotomy tubes with interchangeable inner cannulae – as used in the study.

Appraised by: Richard Price; SpR Stirling Royal Infirmary. ; 21 October 2004

Reviewed & Edited for the SICS EBMG by MG & MH.

Citation: EBM Critical Appraisals. Scottish Intensive Care Society EBM Group. Price R.2004. (Rumbak MJ et al. A prospective, randomised study comparing early percutaneous dilational tracheotomy to prolonged translaryngeal intubation (delayed tracheotomy) in critically ill medical patients. Crit Care Med 2004; 32: 1689 - 1694)

Email: rjp@doctors.org.uk

Kill or Update By: October 2009

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