Clinical trial NCT02148692: Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Surgery
General Anesthesia
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: European Society of Anaesthesiology
First posted: 2014-05-28
Enrollment: 2013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative respiratory failure, particularly after surgery under general anesthesia, adds to the morbidity and mortality of surgical patients. Anesthesiologists inconsistently use positive end-expiratory pressure (PEEP) and recruitment maneuvers in the hope that this may improve oxygenation and protect against postoperative pulmonary complications (PPCs), especially in obese patients. While anesthesiologists tend to use PEEP higher than in non-obese patients. While it is uncertain whether a strategy that uses higher levels of PEEP with recruitment maneuvers truly prevents PPCs in these patients, use of higher levels of PEEP with recruitment maneuvers could compromise intra-operative hemodynamics.

The investigators aim to compare a ventilation strategy using higher levels of PEEP with recruitment maneuvers with one using lower levels of PEEP without recruitment maneuvers in obese patients at an intermediate-to-high risk for PPCs.

We hypothesize that an intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers, as compared to ventilation with lower levels of PEEP without recruitment maneuvers, prevents PPCs in obese patients at an intermediate-to-high risk for PPC.


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for open or laparoscopic surgery under general anesthesia
* Intermediate-to-high risk for PPCs following surgery, according to the ARISCAT risk score (≥ 26)
* BMI ≥ 35 kg/m2
* Expected duration of surgery ≥ 2 h

Exclusion Criteria:

* Age \< 18 years
* Previous lung surgery (any)
* Persistent hemodynamic instability, intractable shock (considered hemodynamically unsuitable for the study by the patient's managing physician)
* History of previous severe chronic obstructive pulmonary disease (COPD) (non-invasive ventilation and/or oxygen therapy at home, repeated systemic corticosteroid therapy for acute exacerbations of COPD)
* Recent immunosuppressive medication (patients receiving chemotherapy or radiation therapy up to two months prior to surgery)
* Severe cardiac disease (New York Heart Association class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias)
* Invasive mechanical ventilation longer than 30 minutes (e.g., general anesthesia for surgery) within last 30 days
* Pregnancy (excluded by anamneses and/or laboratory analysis)
* Prevalent acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
* Severe pulmonary arterial hypertension, defined as systolic pulmonary artery pressure \> 40 mmHg
* Intracranial injury or tumor
* Neuromuscular disease (any)
* Need for intraoperative prone or lateral decubitus position
* Need for one-lung ventilation
* Cardiac surgery
* Neurosurgery
* Planned reintubation following surgery
* Enrolled in other interventional study or refusal of informed consent

Primary outcomes:
measure: Postoperative pulmonary complications
timeFrame: Five postoperative days
measure: Hospital-free days at day 90
timeFrame: 90 postoperative days
measure: Mortality at day 90
timeFrame: 90 postoperative days
measure: Postoperative extra-pulmonary complications
timeFrame: Five postoperative days
measure: Postoperative wound healing
timeFrame: Five postoperative days
Secondary outcomes:
measure: Intra-operative complications
timeFrame: Surgery period
measure: Need for postoperative ventilatory support
timeFrame: Five postoperative days
measure: Unexpected need for ICU admission or ICU readmission within 30 days
timeFrame: Five postoperative days
measure: Need for hospital readmission within 30 days
timeFrame: 30 postoperative days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital, Harvard University
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Vienna
country: Austria
facility: Medical University
city: Brugge
country: Belgium
facility: AZ Sint Jan Brugge-Oostende AV
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Sao Paulo
country: Brazil
facility: ABC Medical School
city: Toronto
country: Canada
facility: Saint Michael's Hospital, University of Toronto
city: Montpellier
country: France
facility: Saint Eloi University Hospital
city: Dresden
country: Germany
facility: Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus
state: Saxony
city: Aachen
country: Germany
facility: University of Aachen
city: Bonn
country: Germany
facility: University of Bonn
city: Leipzig
country: Germany
facility: University of Leipzig
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Foggia
country: Italy
facility: University of Foggia
city: Genoa
country: Italy
facility: University of Genoa
city: Turin
country: Italy
facility: Città della Salute e della Scienza
city: Varese
country: Italy
facility: University of Insubria
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, University of Amsterdam
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
city: Uppsala
country: Sweden
facility: University Hospital Uppsala
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Istanbul
country: Turkey
facility: University of Istanbul
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals
Study officials:
References:
citation: Ellenberger C, Pelosi P, de Abreu MG, Wrigge H, Diaper J, Hagerman A, Adam Y, Schultz MJ, Licker M; PROBESE investigators, of the PROtective VEntilation Network (PROVEnet); Clinical Trial Network of the European Society of Anaesthesiology and Intensive Care (ESAIC). Distribution of ventilation and oxygenation in surgical obese patients ventilated with high versus low positive end-expiratory pressure: A substudy of a randomised controlled trial. Eur J Anaesthesiol. 2022 Nov 1;39(11):875-884. doi: 10.1097/EJA.0000000000001741. Epub 2022 Sep 12.
citation: Writing Committee for the PROBESE Collaborative Group of the PROtective VEntilation Network (PROVEnet) for the Clinical Trial Network of the European Society of Anaesthesiology; Bluth T, Serpa Neto A, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE Collaborative Group; Bluth T, Bobek I, Canet JC, Cinnella G, de Baerdemaeker L, Gama de Abreu M, Gregoretti C, Hedenstierna G, Hemmes SNT, Hiesmayr M, Hollmann MW, Jaber S, Laffey J, Licker MJ, Markstaller K, Matot I, Mills GH, Mulier JP, Pelosi P, Putensen C, Rossaint R, Schmitt J, Schultz MJ, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H. Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial. JAMA. 2019 Jun 18;321(23):2292-2305. doi: 10.1001/jama.2019.7505.
citation: Bluth T, Teichmann R, Kiss T, Bobek I, Canet J, Cinnella G, De Baerdemaeker L, Gregoretti C, Hedenstierna G, Hemmes SN, Hiesmayr M, Hollmann MW, Jaber S, Laffey JG, Licker MJ, Markstaller K, Matot I, Muller G, Mills GH, Mulier JP, Putensen C, Rossaint R, Schmitt J, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE investigators; PROtective VEntilation Network (PROVEnet); Clinical Trial Network of the European Society of Anaesthesiology (ESA). Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients (PROBESE): study protocol for a randomized controlled trial. Trials. 2017 Apr 28;18(1):202. doi: 10.1186/s13063-017-1929-0.