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-…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative pulmonary complications:
Aspiration pneumonitis
Bronchospasm
Mild respiratory failure
Moderate respiratory failure
Severe respiratory failure
ARDS
Pulmonary infection
Atelectasis
Cardiopulmonary edema
Pleural effusion
Pneumothorax
New pulmonary infiltrates
Secondary outcome
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.
Background 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 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.
Study objective
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.
Study design
International multicenter randomized controlled trial.
Intervention
Patients with be either ventilated with PEEP of 12 cmH2O with the use of
recruitment maneuvers (the *higher PEEP level*), or PEEP of 4 cmH2O without
recruitment maneuvers (the *lower PEEP level*). The higher PEEP level group can
be seen as the intervention group.
Study burden and risks
In the intra-operative period, patients will not experience discomfort from
either strategy because of general anesthesia. However, systemic hypotension
could occur in the higher PEEP group, which would be treated with intravascular
volume therapy and/or vasoactive drugs. If the hypothesis proves to be true,
patients in the higher PEEP group could benefit from a lower incidence of PPCs.
Fetscherstrasse 74
Dresden 01307
DE
Fetscherstrasse 74
Dresden 01307
DE
Listed location countries
Age
Inclusion criteria
• Patient scheduled for surgery under general anesthesia
• Intermediate-to-high risk for postoperative pulmonary complications 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT02148692 |
| CCMO | NL50188.018.14 |