Continuous Pneumatic Regulation of Tracheal Cuff Pressure to Decrease Ventilator-associated Pneumonia in Trauma Patients Who Were Mechanically Ventilated: The AGATE Multicenter Randomized Controlled Study.

BACKGROUND: Ventilator-associated pneumonia (VAP) is the most frequent health care-associated infection in severely ill patients, and aspiration of contaminated oropharyngeal content around the cuff of the tracheal tube is the main route of contamination. RESEARCH QUESTION: Is continuous regulation of tracheal cuff pressure using a pneumatic device superior to manual assessment three times daily using a portable manometer (routine care) in preventing VAP in patients with severe trauma? STUDY DESIGN AND METHODS: In this open-label, randomized controlled superiority trial conducted in 13 French ICUs, adults (age ≥ 18 years) with severe trauma (Injury Severity Score > 15) and requiring invasive mechanical ventilation for ≥ 48 h were enrolled. Patients were randomly assigned (1:1) via a secure Web-based random number generator in permuted blocks of variable sizes to one of two groups according to the method of tracheal cuff pressure control. The primary outcome was the proportion of patients developing VAP within 28 days following the tracheal intubation, as determined by two assessors masked to group assignment, in the modified intention-to-treat population. This study is closed to new participants. RESULTS: A total of 434 patients were recruited between July 31, 2015, and February 15, 2018, of whom 216 were assigned to the intervention group and 218 to the control group. Seventy-three patients (33.8%) developed at least one episode of VAP within 28 days following the tracheal intubation in the intervention group compared with 64 patients (29.4%) in the control group (adjusted subdistribution hazard ratio, 0.96; 95% CI, 0.76-1.20; P = .71). No serious adverse events related to the use of the pneumatic device were noted. INTERPRETATION: Continuous regulation of cuff pressure of the tracheal tube using a pneumatic device was not superior to routine care in preventing VAP in patients with severe trauma. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT02534974; URL: www.clinicaltrials.gov.

Impact of restrictive fluid protocol on hypoxemia after aneurysmal subarachnoid hemorrhage.

PURPOSE: In patients with aneurysmal subarachnoid hemorrhage (aSAH), acute cardiac dysfunction and triple-H-therapy, can lead to hypoxemia. Our aim was to assess impact of a protocoled fluid restrictive approach on hypoxemia in these patients. METHODS: We included prospectively ICU patients with aSAH admitted within 24h after the bleed. The study was divided into 2 phases. The first phase, from January to December 2012, was designated as control group (group C). The second phase, from February 2014 to January 2015, was designated as study group (group S). Between these periods, a protocoled fluid intake approach was implemented to maintain as low as possible the cumulative fluid balances. RESULTS: Effective fluid restriction was obtained: at day 3 cumulative fluid balances were respectively for group C and group S, 1559±2402ml and 759±1855ml (p=0.04); and 2211±4918ml vs 529±2806ml (p=0.04) at day 7. We observed reduction in proportion of hypoxemic patient in group S compared to group C, at day 3 (22% vs 40%, p=0.047) and at day 7 (28% vs 57%, p=0.007). CONCLUSIONS: Fluid restrictive management of patients with aSAH decreases number of hypoxemic patients at day 3 and day 7.