Prolonged tracheal intubation in the trauma patient. Tracheostomy in ventilator dependent trauma patients: a prospective, randomized intention-to-treat study. Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial. A prospective, randomized, study comparing early percutaneous dilational tracheotomy to prolonged translaryngeal intubation (delayed tracheotomy) in critically ill medical patients.
Over a 15-month period, 74 trauma patients who were expected to require extended intubation were studied prospectively to evaluate the appropriateness of tracheostomy. Patients were randomized to receive either early (34) or late (40) tracheostomies. The patients also were grouped to determine the difference of early versus late tracheostomy on the development of laryngotracheal pathology and respiratory infections; length of intubation and type of patient injury were studied as possible differential factors. Fifteen per cent (11/74) of the patients developed major laryngotracheal pathology as identified by endoscopy, and respiratory infections developed in 54% (40/74), but there was no significant difference in the complication incidence between the early and late tracheostomy groups. Significantly more complications occurred in rigid-posture, head-injured patients than in any other trauma grouping, but there was no significant difference in the complication incidence between the two tracheostomy groups within that classification. We conclude that patients can undergo translaryngeal intubation for up to 2 weeks without significantly increasing complications relative to transtracheal intubation. Tracheostomy is a commonly performed procedure in ventilator dependent patients. Many critical care practitioners believe that performing a tracheostomy early in the postinjury period decreases the length of ventilator dependence as well as having other benefits such as better patient tolerance and lower respiratory dead space. We conducted a randomized, prospective, single institution study comparing the length ventilator dependence in critically ill multiple trauma patients who were randomized to two different strategies for performance of a tracheostomy. We hypothesized that earlier tracheostomy would reduce the number of days of mechanical ventilation, frequency of pneumonia and length of intensive care unit (ICU) stay.
                Patients were eligible if they were older than 15 years and either a Glasgow Coma Score (GCS) >4 with a negative brain computed tomography (CT) (no anatomic head injury), or a GCS >9 with a positive head CT (known anatomic head injury). Patients who required tracheostomy for facial/neck injuries were excluded. Patients were randomized to an intention to treat strategy of tracheostomy placement before day 8 or after day 28.
                The study was halted after the first interim analysis. There were 60 enrolled patients, who had comparable demographics between groups. There was no significant difference between groups in any outcome variable including length of ventilator support, pneumonia rate, or death.
                A strategy of tracheostomy before day 8 postinjury in this group of trauma patients did not reduce the number of days of mechanical ventilation, frequency of pneumonia or ICU length of stay as compared with the group with a tracheostomy strategy involving the procedure at 28 days postinjury or more. Tracheotomy is used to replace endotracheal intubation in patients requiring prolonged ventilation; however, there is considerable variability in the time considered optimal for performing tracheotomy. This is of clinical importance because timing is a key criterion for performing a tracheotomy and patients who receive one require a large amount of health care resources.
                To determine the effectiveness of early tracheotomy (after 6-8 days of laryngeal intubation) compared with late tracheotomy (after 13-15 days of laryngeal intubation) in reducing the incidence of pneumonia and increasing the number of ventilator-free and intensive care unit (ICU)-free days.
                Randomized controlled trial performed in 12 Italian ICUs from June 2004 to June 2008 of 600 adult patients enrolled without lung infection, who had been ventilated for 24 hours, had a Simplified Acute Physiology Score II between 35 and 65, and had a sequential organ failure assessment score of 5 or greater.
                Patients who had worsening of respiratory conditions, unchanged or worse sequential organ failure assessment score, and no pneumonia 48 hours after inclusion were randomized to early tracheotomy (n = 209; 145 received tracheotomy) or late tracheotomy (n = 210; 119 received tracheotomy).
                The primary endpoint was incidence of ventilator-associated pneumonia; secondary endpoints during the 28 days immediately following randomization were number of ventilator-free days, number of ICU-free days, and number of patients in each group who were still alive.
                Ventilator-associated pneumonia was observed in 30 patients in the early tracheotomy group (14%; 95% confidence interval [CI], 10%-19%) and in 44 patients in the late tracheotomy group (21%; 95% CI, 15%-26%) (P = .07). During the 28 days immediately following randomization, the hazard ratio of developing ventilator-associated pneumonia was 0.66 (95% CI, 0.42-1.04), remaining connected to the ventilator was 0.70 (95% CI, 0.56-0.87), remaining in the ICU was 0.73 (95% CI, 0.55-0.97), and dying was 0.80 (95% CI, 0.56-1.15).
                Among mechanically ventilated adult ICU patients, early tracheotomy compared with late tracheotomy did not result in statistically significant improvement in incidence of ventilator-associated pneumonia.
                clinicaltrials.gov Identifier: NCT00262431. The timing of tracheotomy in patients requiring mechanical ventilation is unknown. The effects of early percutaneous dilational tracheotomy compared with delayed tracheotomy in critically ill medical patients needing prolonged mechanical ventilation were assessed.
                Prospective, randomized study.
                Medical intensive care units.
                One hundred and twenty patients projected to need ventilation >14 days.
                None.
                Patients were prospectively randomized to either early percutaneous tracheotomy within 48 hrs or delayed tracheotomy at days 14-16. Time in the intensive care unit and on mechanical ventilation and the cumulative frequency of pneumonia, mortality, and accidental extubation were documented. The airway was assessed for oral, labial, laryngeal, and tracheal damage. Early group showed significantly less mortality (31.7% vs. 61.7%), pneumonia (5% vs. 25%), and accidental extubations compared with the prolonged translaryngeal group (0 vs. 6). The early tracheotomy group spent less time in the intensive care unit (4.8 +/- 1.4 vs. 16.2 +/- 3.8 days) and on mechanical ventilation (7.6 +/- 2.0 vs. 17.4 +/- 5.3 days). There was also significantly more damage to mouth and larynx in the prolonged translaryngeal intubation group.
                This study demonstrates that the benefits of early tracheotomy outweigh the risks of prolonged translaryngeal intubation. It gives credence to the practice of subjecting this group of critically ill medical patients to early tracheotomy rather than delayed tracheotomy.
Updated evidence is of low quality, and potential differences between early and late tracheostomy need to be better investigated by means of randomized controlled trials. At present there is no specific information about any subgroup or individual characteristics potentially associated with better outcomes with either early or late tracheostomy.