Review: A Prospective, Randomised Study Comparing Early Percutaneous Dilational Tracheotomy to Prolonged Translaryngeal Intubation (Delayed Tracheotomy) in Critically Ill Medical Patients

It has long been recognised that prolonged endotracheal intubation is associated with adverse effects, some of which can be alleviated by the formation of a tracheostomy. Tracheostomies result in fewer self-extubations and tube misplacements, improve patient comfort and allow withdrawal of sedation, communication and oral feeding to be achieved more rapidly. Percutaneous tracheostomy is now well established and although not free from complications, has a procedural safety at least comparable to conventional tracheostomy. The optimum timing for tracheostomy remains controversial. The aim of this study was therefore to compare outcomes from early versus delayed percutaneous tracheostomy. Design This was a prospective, randomised study with intention to treat, conducted in two American medical intensive care units. One hundred and thirty-five medical patients requiring intubation and mechanical ventilation for acute respiratory failure were recruited on admission, if they met the inclusion criteria: age > 18yrs, APACHE II score >25 and a projected need for ventilatory support of >14 days. Informed consent could be obtained in only 120 cases. Patients were excluded if they had a coagulopathy, thrombocytopenia, localised infection, PEEP > 12 cms H2O, were beyond 48 hours of intubation or if percutaneous tracheostomy was felt to be technically difficult because of existing anatomy, deformity or previous tracheostomy. Patients were randomised to receive early tracheostomy (within 48hrs) or late tracheostomy (at 14-16 days) using a wire guided dilational technique under bronchoscopic guidance. Outcome measures consisted of mortality, time in the ICU and on mechanical ventilation and the frequency of pneumonia and accidental extubation. Evidence of airway damage was also sought. The sample size of 60 in each group was determined for a 50% reduction in the incidence of ventilator associated pneumonia (VAP) from a predicted baseline of 50%. Standardised weaning and sedation protocols were adopted. Results The demographics for each group were similar. Early tracheostomy was associated with several advantages over late tracheostomy: A lower mortality: 19 patients (31.7%) vs 37 patients (61.7%). A lower incidence of VAP: 3 patients (5%) vs 15 patients (25%). A shorter ITU stay: 4.8 days vs 16.2 days. A shorter ventilatory period: 7.6 days vs 17.4 days. A reduced need for sedation: 3.2 days vs 14.1 days A reduced number of inadvertent extubations: 0 vs 6. There was no significant difference between the 2 groups in terms of use of pressor agents or the incidence of local complications affecting the mouth, larynx and trachea. There was one procedural complication requiring suture insertion to control minor bleeding. Of the 60 patients randomised to delayed tracheostomy, 8 were extubated before receiving a tracheostomy. Conclusions This study advocates the early use of tracheostomy in medical patients, based on reduced risks compared with prolonged translaryngeal intubation. Are the results valid? Primary Guides Randomisation was performed using a closed envelope method. Of the 135 patients eligible for the study, consent could not be obtained in 15 cases. The remainder could be accounted for on completion of the study. Secondary Guides The two groups were well matched in terms of age, sex, race, APACHE II score and underlying condition. Due to the nature of the intervention, blinding was not possible. Sedation and weaning protocols were stated and were applied to all patients in the study. Patients were moved from the intensive care unit to a step down or ventilator floor once their airway was secure, they were haemodynamically stable and no requirement existed for ICU care. This resulted in more of the early tracheostomy patients being transferred out of the ICU quicker than the intubated patients. This may have resulted in differences in treatment. A prospective, randomised study comparing early percutaneous dilational tracheotomy to prolonged translaryngeal intubation (delayed tracheotomy) in critically ill medical patients