Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01441791 · ClinicalTrials.gov registry record · NA
PROVHILO:Protective Ventilation During General Anesthesia for Open Abdominal Surgery
A NA study, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
- Completed
- Registry status
- NA
- Development phase
- 900
- Enrollment target
NCT01441791 is a NA study that has completed, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The registered enrollment target is 900 participants.
The verdict
NCT01441791, a NA study, has completed, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
- COMPLETED
- Registry status
- NA
- Development phase
- 900 participants
- Enrollment target
Study 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 Pressure) during general anesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery. Participating centres throughout the world will include a total of 900 adult patients undergoing general anesthesia for open abdominal surgery with high or intermediate risk for post-operative pulmonary complications. Patients are randomized and intra-operatively ventilated with either a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers) or a conventional strategy (PEEP at maximum 2 cmH2O without recruitment maneuvers). Patients will be assessed on the first 5 post-operative days, on day of discharge and on day 90 post-operative. Primary endpoint is any post-operative pulmonary complication (see below). Secondary endpoints are post-operative extra-pulmonary complications, intra-operative mechanical ventilation related complications, unscheduled ICU (Intensive Care Unit) (re-) admission, and length of hospital stay.
Interventions
- PROCEDURE Lung protective strategy ventilation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01441791
The ClinicalTrials.gov registry entry for NCT01441791 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 900 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Lung protective strategy ventilation is the first listed.
NCT01441791 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01441791 about?
NCT01441791 is a clinical study titled "PROVHILO:Protective Ventilation During General Anesthesia for Open Abdominal Surgery". 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 Pressure) during general anesthesia reduces atelectasis formation and improves respiratory function ...
What is the current status of trial NCT01441791?
This trial is currently completed. It is a NA study. The enrollment target is 900 participants. The study started on 2011-02. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01441791?
The interventions under investigation include: Lung protective strategy ventilation (PROCEDURE).
Who is sponsoring clinical trial NCT01441791?
This trial is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.