Ventilación intraoperatoria protectora con niveles más altos o más bajos de presión positiva de expiración final en pacientes obesos (PROBESE): protocolo de estudio para un ensayo controlado aleatorio.
Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial.
Bluth T1, Teichmann R1, Kiss T1, Bobek I2, Canet J3, Cinnella G4, De Baerdemaeker L5, Gregoretti C6, Hedenstierna G7, Hemmes SN8,9, Hiesmayr M10,11,12,13, Hollmann MW8,9, Jaber S14, Laffey JG15,16,17,18, Licker MJ19, Markstaller K13, Matot I20, Müller G21, Mills GH22, Mulier JP23, Putensen C24, Rossaint R25, Schmitt J21, Senturk M26, Serpa Neto A27,28, Severgnini P29, Sprung J30, Vidal Melo MF31, Wrigge H32, Schultz MJ9,33, Pelosi P34, Gama de Abreu M35; PROBESE investigators; and the PROtective VEntilation Network (PROVEnet); Clinical Trial Network of the European Society of Anaesthesiology (ESA).
Trials. 2017 Apr 28;18(1):202. doi: 10.1186/s13063-017-1929-0.
Abstract
BACKGROUND: Postoperative pulmonary complications (PPCs) increase the morbidity and mortality of surgery in obese patients. High levels of positive end-expiratory pressure (PEEP) with lung recruitment maneuvers may improve intraoperative respiratory function, but they can also compromise hemodynamics, and the effects on PPCs are uncertain. We hypothesized that intraoperative mechanical ventilation using high PEEP with periodic recruitment maneuvers, as compared with low PEEP without recruitment maneuvers, prevents PPCs in obese patients. METHODS/DESIGN: The PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients (PROBESE) study is a multicenter, two-arm, international randomized controlled trial. In total, 2013 obese patients with body mass index ≥35 kg/m2 scheduled for at least 2 h of surgery under general anesthesia and at intermediate to high risk for PPCs will be included. Patients are ventilated intraoperatively with a low tidal volume of 7 ml/kg (predicted body weight) and randomly assigned to PEEP of 12 cmH2O with lung recruitment maneuvers (high PEEP) or PEEP of 4 cmH2O without recruitment maneuvers (low PEEP). The occurrence of PPCs will be recorded as collapsed composite of single adverse pulmonary events and represents the primary endpoint. DISCUSSION: To our knowledge, the PROBESE trial is the first multicenter, international randomized controlled trial to compare the effects of two different levels of intraoperative PEEP during protective low tidal volume ventilation on PPCs in obese patients. The results of the PROBESE trial will support anesthesiologists in their decision to choose a certain PEEP level during general anesthesia for surgery in obese patients in an attempt to prevent PPCs.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02148692. Registered on 23 May 2014; last updated 7 June 2016.
KEYWORDS: Mechanical ventilation; Obesity; Positive end-expiratory pressure; Postoperative pulmonary complication; Recruitment maneuver
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