PROBESE
Research type
Research Study
Full title
PRotective Ventilation with Higher versus Lower PEEP during General Anesthesia for Surgery in OBESE Patients – The PROBESE Randomized Controlled Trial
IRAS ID
167739
Contact name
Gary H Mills
Contact email
Sponsor organisation
University Hospital Dresden
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Introduction
Deterioration of breathing to the point that patients need artificial help with breathing after surgery is a major problem and can lead to the death of surgical patients. Anaesthetists inconsistently use positive end–expiratory pressure (PEEP), which is a way of preventing small airways in the lungs from closing up during operations. Some may use recruitment manoeuvres, whereby the lungs are inflated with some large artificial breaths to reopen closed airways, in the hope that this may improve oxygenation and protect against lung problems after the operation. These lung problems are normally referred to as postoperative pulmonary complications (PPCs) and often are worse in obese patients. It is uncertain whether using higher levels of PEEP with recruitment manoeuvres truly prevents PPCs. The balance between the helpful effect on the lung versus any unhelpful effects on blood pressure is unknown in obese patients. Therefore it is important to find out if PEEP and recruitment manoeuvres are helpful overall.
Objectives
To compare ventilation using higher levels of PEEP with recruitment manoeuvres against using lower levels of PEEP without recruitment manoeuvres in obese patients at an intermediate–to–high risk for PPCs.
Hypotheses
Higher levels of PEEP and recruitment manoeuvres during surgery, as compared to ventilation with lower levels of PEEP without recruitment manoeuvres, prevents PPCs in obese patients at an intermediate–to–high risk for PPC.
Study design
International multicentre randomized controlled trial.
Study population
Obese patients with BMI = 35 kg/m2 at intermediate–to–high risk for PPCs scheduled for surgery under general anaesthesia.
Main study parameters/endpoints
The primary endpoint is the proportion of patients with PPCs. Secondary endpoints include intra–operative complications, need for postoperative ventilatory support (invasive and/or non–invasive ventilation), need for unexpected ICU admission or ICU readmission, the number of hospital–free days and 90-day survival/mortality.REC name
Wales REC 4
REC reference
15/WA/0106
Date of REC Opinion
25 Jun 2015
REC opinion
Further Information Favourable Opinion