Effect of a lung protective strategy for organ donors on eligibility and availability of lungs for transplantation: a randomized controlled trial.

CONTEXT: Many potential donor lungs deteriorate between the time of brain death and evaluation for transplantation suitability, possibly because of the ventilatory strategy used after brain death. OBJECTIVE: To test whether a lung protective strategy increases the number of lungs available for transplantation. DESIGN, SETTING, AND PATIENTS: Multicenter randomized controlled trial of patients with beating hearts who were potential organ donors conducted at 12 European intensive care units from September 2004 to May 2009 in the Protective Ventilatory Strategy in Potential Lung Donors Study. Interventions Potential donors were randomized to the conventional ventilatory strategy (with tidal volumes of 10-12 mL/kg of predicted body weight, positive end-expiratory pressure [PEEP] of 3-5 cm H(2)O, apnea tests performed by disconnecting the ventilator, and open circuit for airway suction) or the protective ventilatory strategy (with tidal volumes of 6-8 mL/kg of predicted body weight, PEEP of 8-10 cm H(2)O, apnea tests performed by using continuous positive airway pressure, and closed circuit for airway suction). MAIN OUTCOME MEASURES: The number of organ donors meeting eligibility criteria for harvesting, number of lungs harvested, and 6-month survival of lung transplant recipients. RESULTS: The trial was stopped after enrolling 118 patients (59 in the conventional ventilatory strategy and 59 in the protective ventilatory strategy) because of termination of funding. The number of patients who met lung donor eligibility criteria after the 6-hour observation period was 32 (54%) in the conventional strategy vs 56 (95%) in the protective strategy (difference of 41% [95% confidence interval {CI}, 26.5% to 54.8%]; P <.001). The number of patients in whom lungs were harvested was 16 (27%) in the conventional strategy vs 32 (54%) in the protective strategy (difference of 27% [95% CI, 10.0% to 44.5%]; P = .004). Six-month survival rates did not differ between recipients who received lungs from donors ventilated with the conventional strategy compared with the protective strategy (11/16 [69%] vs 24/32 [75%], respectively; difference of 6% [95% CI, -22% to 32%]). CONCLUSION: Use of a lung protective strategy in potential organ donors with brain death increased the number of eligible and harvested lungs compared with a conventional strategy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00260676.

Early vs late tracheotomy for prevention of pneumonia in mechanically ventilated adult ICU patients: a randomized controlled trial.

CONTEXT: 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. OBJECTIVE: 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. DESIGN, SETTING, AND PATIENTS: 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. INTERVENTION: 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). MAIN OUTCOME MEASURES: 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. RESULTS: 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). CONCLUSION: 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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00262431.

Reliability of optic nerve ultrasound for the evaluation of patients with spontaneous intracranial hemorrhage.

INTRODUCTION: The aim of our study is to confirm the reliability of optic nerve ultrasound as a method to detect intracranial hypertension in patients with spontaneous intracranial hemorrhage, to assess the reproducibility of the measurement of the optic nerve sheath diameter (ONSD), and to verify that ONSD changes concurrently with intracranial pressure (ICP) variations. METHODS: Sixty-three adult patients with subarachnoid hemorrhage (n = 34) or primary intracerebral hemorrhage (n = 29) requiring sedation and invasive ICP monitoring were enrolled in a 10-bed multivalent ICU. ONSD was measured 3 mm behind the globe through a 7.5-MHz ultrasound probe. Mean binocular ONSD was used for statistical analysis. ICP values were registered simultaneously to ultrasonography. Twenty-eight ONSDs were measured consecutively by two different observers, and interobserver differences were calculated. Twelve coupled measurements were taken before and within 1 min after cerebrospinal fluid (CSF) drainage to control elevated ICP. RESULTS: Ninety-four ONSD measurements were analyzed. 5.2 mm proved to be the optimal ONSD cut-off point to predict raised ICP (>20 mmHg) with 93.1% sensitivity (95% CI: 77.2-99%) and 73.85% specificity (95% CI: 61.5-84%). ONSD-ICP correlation coefficient was 0.7042 (95% CI for r = 0.5850-0.7936). The median interobserver ONSD difference was 0.25 mm. CSF drainage to control elevated ICP caused a rapid and significant reduction of ONSD (from 5.89 ± 0.61 to 5 ± 0.33 mm, P < 0.01). CONCLUSION: Our investigation confirms the reliability of optic nerve ultrasound as a non-invasive method to detect elevated ICP in intracranial hemorrhage patients. ONSD measurements proved to have a good reproducibility. ONSD changes almost concurrently with CSF pressure variations.