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. Early compared with late radiotherapy in combined modality treatment for limited disease small-cell lung cancer: a London Lung Cancer Group multicenter randomized clinical trial and meta-analysis. Is delayed surgery really better for congenital diaphragmatic hernia?: a prospective randomized clinical trial. Adaptive support ventilation for fast tracheal extubation after cardiac surgery: a randomized controlled study. Postoperative respiratory care: a controlled trial of early and late extubation following coronary-artery bypass grafting. Post-tympanostomy otorrhea: a randomized clinical trial of topical prophylaxis.
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. To replicate an earlier National Cancer Institute of Canada (NCIC) trial that examined the effect on survival of the timing of thoracic radiotherapy (TRT) in patients with limited disease small-cell lung cancer (SCLC).
                Patients received three cycles of cyclophosphamide, doxorubicin, and vincristine alternating with three cycles of etoposide and cisplatin. Three hundred twenty five chemotherapy- and radiotherapy-naïve patients were randomly assigned to either early TRT administered concurrently in the second cycle or late TRT administered concurrently with the sixth cycle; the dose was 40 Gy in 15 fractions over 3 weeks.
                TRT was received by 92% and 82% of patients in the early and late arms, respectively (P = .01). Sixty-nine percent of patients in the early arm received all six courses of chemotherapy compared with 80% in the late arm (P = .003). There was no evidence of a survival difference; median overall survival time was 13.7 and 15.1 months in the early and late arms, respectively (P = .23). In a meta-analysis of all eight trials that compared early and late TRT, there were three in which the proportion of patients who completed their planned chemotherapy was similar between the TRT arms (hazard ratio [HR] = 0.73; 95% CI, 0.62 to 0.86) and five in which proportionally fewer patients in the early TRT arm completed their chemotherapy (HR = 1.06; 95% CI, 0.97 to 1.17).
                This study failed to show a survival advantage for early TRT with chemotherapy in limited-stage SCLC, unlike the NCIC trial. However, the results of a meta-analysis suggest that it is essential to ensure that the delivery of chemotherapy is optimal when administered with early TRT. Delayed surgery has become widely accepted in the management of congenital diaphragmatic hernia after comparing outcomes only with historical retrospective controls. It was the aim of this study to compare early and delayed hernia repair in a randomized prospective clinical trial. Fifty-four infants were randomized to receive either early repair (within 4 hours of admission) or delayed repair (more than 24 hours after birth). The survival rate was higher for the delayed group (57% v 46%), but the difference was not significant (difference: -11; 95% confidence limits: -37.5, 15.5). There were no significant differences between the two groups with respect to length of hospital stay, ventilator dependency, or survival time. Recorded preoperative risk factors were similar for the two groups. Eight infants in the delayed repair group died without having undergone surgery. The optimum time for surgery still needs clarification. Adaptive support ventilation (ASV) is a microprocessor-controlled mode of mechanical ventilation that maintains a predefined minute ventilation with an optimal breathing pattern (tidal volume and rate) by automatically adapting inspiratory pressure and ventilator rate to changes in the patient's condition. The aim of the current study was to test the hypothesis that a protocol of respiratory weaning based on ASV could reduce the duration of tracheal intubation after uncomplicated cardiac surgery ("fast-track" surgery).
                A group of patients being given ASV (group ASV) was compared with a control group (group control) in a randomized controlled study. After coronary artery bypass grafting during general anesthesia with midazolam and fentanyl, patients were randomly assigned to group ASV or group control. Both protocols were divided into three predefined phases, and weaning progressed according to arterial blood gas and clinical criteria. In phase 1, ASV mode was set at 100% of the theoretical value of volume/minute in group ASV, and synchronized intermittent mandatory ventilation mode was used in group control. When spontaneous breathing occurred, ASV setting was reduced by 50% of minute ventilation (phase 2) and again by 50% (phase 3), and the trachea was extubated. In group control, the ventilator was switched to 10 cm H2O inspiratory pressure support (phase 2), then to 5 cm H2O (phase 3) until extubation.
                Forty-nine patients were enrolled. Sixteen patients completed the ASV protocol, and 20 the standard protocol; 7 patients were excluded in group ASV and 6 in group control according to explicit, predefined criteria. There were no differences between groups in perioperative characteristics or in the doses of sedation. The primary outcome of the study, that is, the duration of tracheal intubation, was shorter in group ASV than in group control (median [quartiles]: 3.2 [2.5-4.6] vs. 4.1 [3.1-8.6] h; P < 0.02). Fewer arterial blood analyses were performed in group ASV (median number [quartiles]: 3 [3-4] vs. 4 [3-6]), suggesting that fewer changes in the settings of the ventilator were required in this group.
                A respiratory weaning protocol based on ASV is practicable; it may accelerate tracheal extubation and simplify ventilatory management in fast-track patients after cardiac surgery. The evaluation of potential advantages of the use of such technology on patient outcome and resource utilization deserves further studies. Sequelae of early versus late extubation of the trachea in patients following coronary-artery bypass grafting were compared prospectively in 38 patients randomly assigned to one of the two groups. The times to extubation were 2 +/- 2 and 18 +/- 3 hours after operation for the two groups. Comparisons were made between groups for the following five variables: time spent in the intensive care unit; drug utilization in the intensive care unit; cardiopulmonary morbidity; hemodynamic performance; patient stress (plasma norepinephrine levels). The anesthetic technique consisted of induction with thiopental, nitrous oxide, and halothane, followed by maintenance with nitrous oxide and halothane. Pancuronium was the only muscle relaxant administered. Patients whose tracheas were extubated early had muscle relaxants reversed prior to the application of extubation criteria. There was no significant difference between the groups in times spent in the intensive care unit, hemodynamic performances, or plasma norepinephrine levels; however, the patients whose tracheas were extubated early received less morphine and diazepam and suffered significantly less cardiopulmonary morbidity. Myringotomy with the insertion of tympanostomy tubes has become the most frequently performed otolaryngologic procedure, and otorrhea is the most common post-tympanostomy complication. Many otolaryngologists routinely use prophylactic topical antibiotic solutions when performing tympanostomy tube placement. Relatively little has been written regarding early post-tympanostomy otorrhea and scarcely any examining the efficacy of such prophylaxis. The current study is a randomized clinical trial to critically evaluate the efficacy of prophylactic otic drops after tympanostomy tube placement. The ototoxic potential of these solutions, combined with constant pressures to decrease medication expenses and eliminate unnecessary use of antibiotics, makes determination of the shortest effective course of application paramount. Subjects were randomized at the time of surgery into one of three groups: one group received no prophylaxis, a second group received gentamicin otic drops immediately after tympanostomy tube placement in the operating room only, and the third group received an additional 48 hours of drops (4 drops in each ear, three times a day). All patients were seen within 2 weeks postoperatively. An overall early post-tympanostomy otorrhea incidence of 8.7% is documented with 12%, 8.8%, and 5.6% for each study group, respectively. While these findings may suggest possible efficacy of topical prophylaxis, a statistically significant difference between the treatment groups was not proved (p = 0.62). Further analysis by subdivision of the patients, on the basis of middle ear cavity finding at the time of surgery, reveals a highly significant statistical association of the occurrence of post-tympanostomy otorrhea in ears having mucoid effusions (p less than 0.001) as compared to ears without effusion or with serous effusions.(ABSTRACT TRUNCATED AT 250 WORDS)
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.