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Completed

NCT Number: NCT02148692

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

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.

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Key information

Conditions

Morbid Obesity Body Weight General Anesthesia Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Higher PEEP

Procedure

Lower PEEP

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • European Society of Anaesthesiology

Registry information

Acronym: PROBESE

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 28, 2014
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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