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Protective Ventilation With Higher Versus Lower PEEP During General Anesthesia for Surgery in Obese Patients (PROBESE)

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ClinicalTrials.gov Identifier: NCT02148692
Recruitment Status : Completed
First Posted : May 28, 2014
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
European Society of Anaesthesiology
Information provided by (Responsible Party):
Technische Universität Dresden

Study Description
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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.


Condition or disease Intervention/treatment Phase
Morbid Obesity Surgery General Anesthesia Procedure: Higher PEEP Procedure: Lower PEEP Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2013 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Actual Study Start Date : July 2014
Actual Primary Completion Date : February 2018
Actual Study Completion Date : May 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Higher PEEP
PEEP of 12 cmH2O or higher and lung recruitment maneuvers
 Procedure: Higher PEEP
Active Comparator: Lower PEEP
PEEP of 4 cmH2O without lung recruitment maneuvers
 Procedure: Lower PEEP


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative pulmonary complications [ Time Frame: Five postoperative days ]
  2. Hospital-free days at day 90 [ Time Frame: 90 postoperative days ]
  3. Mortality at day 90 [ Time Frame: 90 postoperative days ]
  4. Postoperative extra-pulmonary complications [ Time Frame: Five postoperative days ]
  5. Postoperative wound healing [ Time Frame: Five postoperative days ]

Secondary Outcome Measures :
  1. Intra-operative complications [ Time Frame: Surgery period ]
    complications related to the ventilation strategy (for example: de-saturation, defined as SpO2 ≤ 92%, for > 1 min; hypotension during recruitment maneuvers, as defined by systolic arterial pressure < 90 mmHg for > 2 min)

  2. Need for postoperative ventilatory support [ Time Frame: Five postoperative days ]
    invasive or non-invasive ventilation

  3. Unexpected need for ICU admission or ICU readmission within 30 days [ Time Frame: Five postoperative days ]
  4. Need for hospital readmission within 30 days [ Time Frame: 30 postoperative days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148692


Locations
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Sponsors and Collaborators
Technische Universität Dresden
European Society of Anaesthesiology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. Erratum In: JAMA. 2019 Nov 12;322(18):1829-1830.
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. Erratum In: Trials. 2017 Jun 1;18(1):247.

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Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02148692    
Other Study ID Numbers: ANE-PROBESE
First Posted: May 28, 2014    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overweight
 Overnutrition
Nutrition Disorders
Body Weight