Status:
COMPLETED
PROVHILO:Protective Ventilation During General Anesthesia for Open Abdominal Surgery
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
European Society of Anaesthesiology
Conditions:
Postoperative Respiratory Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this international, multicentre, double-blinded randomized controlled trial is to determine if the "open lung approach" providing recruitment maneuvers and PEEP(Positive End Expiratory ...
Detailed Description
Research questions 1. Does mechanical ventilation with the use of higher levels of PEEP(Positive End Expiratory Pressure) and intra-operative RMs (Recruitment maneuvers) protect against pulmonary com...
Eligibility Criteria
Inclusion
- Open abdominal surgery
- General anesthesia
- High or intermediate risk for postoperative pulmonary complications according to ARISCAT score \[J.Canet et al, Anesthesiology 2010;113\]
Exclusion
- Age \> 18 years
- Body mass index \> 40 kg/m2
- Laparoscopic surgery
- Previous lung surgery (any)
- Persistent hemodynamic instability, intractable shock (considered hemodynamic 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 (receiving chemotherapy or radiation therapy within last 2 months)
- Severe cardiac disease (New York Heart Association class III or IV, or acute coronary syndrome, or persistent ventricular tachyarrhythmia's)
- Mechanical ventilation \> than 30 minutes (e.g., in cases of general anesthesia because of surgery) within last 30 days
- Pregnancy (excluded by laboratory analysis)
- Acute lung injury or acute respiratory distress syndrome expected to require prolonged postoperative mechanical ventilation
- Neuromuscular disease (any)
- Consented for another interventional study or refusal to participate in the study
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT01441791
Start Date
February 1 2011
End Date
April 1 2013
Last Update
December 9 2014
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Mayo Clinics
Rochester, New York, United States, 55905
3
Medical University,
Vienna, Austria
4
Ziekenhuis Netwerk Antwerpen
Antwerp, Belgium