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Percutaneous Tracheostomy

 

 

Principal Investigator: Dr Richard Price

 

Early tracheostomy: A review of the available evidence from a meta-analysis and its composite controlled studies.

 

Current State: Complete  (July 2006)

 

EBM Reviews Griffiths, 2005 Rumbak, 2004 Bouderka, 2004 Saffle, 2002 Rodriguez, 1990 Dunham, 1984

 

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Early tracheostomy: A review of the available evidence from a meta-analysis and its composite controlled studies.

 

 

 

Bottom Line: Early tracheostomy may be of benefit for ventilated patients, but this needs to be subject to rigorous randomised controlled trials.

 

 

Investigators: Drs RJ Price, D Swann and M Hughes on behalf of the SICS EBM group.

 

Correspondence: Richard Price, Spr,  West of Scotland Anaesthetic Rotation: rjp@doctors.org.uk

 

Citation: EBM Reviews. Scottish Intensive Care Society EBM Group. Price RJ, Swann D, Hughes M. Early tracheostomy: A review of the available evidence from a meta-analysis and its composite controlled studies. June 2006. 

 

Background: Tracheostomy is commonly performed in the ICU and has a number of perceived advantages. It is unclear, however, if the timing of tracheostomy has any effect on outcomes such as death; ventilation duration; incidence of pneumonia and ICU stay. There have been a large number of studies looking into this. Recently, the randomised controlled trials of Rumbak et al and Bouderka et al, and a meta-analysis by Griffiths et al have been published. 

 

Objectives: to critically appraise the available evidence for early tracheostomy. 

 

Search strategy and study selection: We reviewed the meta-analysis of Griffiths et al, and the individual studies that contributed to this. 

 

Main Conclusions: Five composite studies looked at early tracheostomy. These were the only reasonable randomised controlled trials identified in the English language literature. Each study only looked at a selected group of patients rather than a heterogenous intensive care population. Each study had limitations. Overall, we concluded that three of these five studies had significant sources of bias, and we graded them as evidence level 1-. Two studies were methodologically sounder and we graded them as evidence level 1+.  We considered that one study had such limitations that it should not have been included in the meta-analysis. One study did not address early vs late tracheostomy at all. Not all studies reported all outcomes; the total patient population was 406.

 

For each study, if we ask the question “is the only difference between the groups the intervention” then it is difficult to say “yes” with certainty for any of them.

 

The outcomes looked at are addressed more fully in the CAT of the meta-analysis and the individual studies. However, it may be possible to conclude:

 

  • Mortality. Early tracheostomy may not improve mortality when applied to the mixed population derived from the meta-analysis (level of recommendation grade C). It may improve mortality in medical patients with APACHE II > 25 (B), but not in patients with burns (B), head injuries (C) or multi-trauma (C).

 

  • Pneumonia. Early tracheostomy may not change the incidence of pneumonia when applied to the mixed population derived from the meta-analysis (grade C). It may reduce the incidence in medical patients with APACHE II > 25 (B) and multi-trauma patients (C) but not in patients with burns (B) or head injuries (C). There are many potential confounders here, particularly with respect to the definition, diagnosis and prevention of pneumonia.

 

  • Ventilator days. Early tracheostomy may reduce the duration of ventilation when applied to the mixed population derived from the meta-analysis (grade C). This also applies to medical patients with APACHE II > 25 (B), patients with head injuries (C) or multi-trauma (C) but not in patients with burns (B). There are issues here with respect to the use of comparable ventilation, weaning and sedation between the two groups in each study.

 

  • Intensive care stay. Early tracheostomy may reduce ICU stay when applied to the mixed population derived from the meta-analysis (grade C). This also applies to medical patients with APACHE II > 25 (B) and multi-trauma patients (C). We need to be very careful in interpreting this since there were only two studies that contributed to this conclusion. This is a soft outcome and rather prone to bias.

 

Implications for future studies: Multi-centre RCTs are currently underway to address this issue. Taking lessons from these earlier trials, these studies could reduce sources of bias in several ways. At least, we should ask these questions when reviewing the results.

 

How were the patients selected to enter the trial? Were there any objective criteria? How many patients received a tracheostomy that were not in the trial?

 

Were the patients who kept their trans-laryngeal tube treated the same? Were they awake? Was there a comparable protocol for ventilation and weaning?

 

How was pneumonia diagnosed? Were the criteria accepted and appropriate? Was it independent of the investigators? Which strategies were used to prevent VAP?

 

Surely these studies need to have three arms: early tracheostomy, late tracheostomy and no tracheostomy? One potential problem with a multi-centre pragmatic study is that many of these factors are uncontrollable by the study design. Unlike a drug study there can be neither blinding nor placebo control. It will be unlikely that control and intervention groups are treated in comparable ways.

 

References and links to CATS:

 

1.      Griffiths J, Barber VS, Morgan L, Young JD. Systematic review and meta-analysis of studies of the timing of tracheostomy in adult patients undergoing artificial ventilation. BMJ. 2005; 330: 1243-1248. CAT.

2.      Rumbak MJ, Newton M, Truncale T, Schwartz SW, Adams JW, Hazard PB. A prospective, randomised study comparing early percutaneous dilational tracheotomy to prolonged translaryngeal intubation (delayed tracheotomy) in critically ill medical patients. Critical Care Medicine 2004; 32: 1689 – 1694. CAT.

3.      Bouderka MA, Fakhir B, Bouaggad A, Hmamouchi B, Hamoudi D, Harti A. Early tracheostomy versus prolonged endotracheal intubation in severe head injury. Journal of Trauma. 2004; 57: 251-254. CAT.

4.      Saffle JR, Morris SE, Edelman L. Early tracheostomy does not improve outcome in burn patients. Journal of Burn Care and Rehabilitation. 2002; 23: 431-438. CAT.

5.      Rodriguez JL, Steinberg SM, Luchetti FA, Gibbons KJ, Taheri PA, Flint LM. Early tracheostomy for primary airway management in the surgical critical care setting. Surgery. 1990; 108: 655-659. CAT.

6.      Dunham CM, LaMonica C. Prolonged tracheal intubation in the trauma patient. Journal of Trauma – Injury, Infection and Critical Care. 1984; 24: 120-124. CAT.

 

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