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NCT04108130 · ClinicalTrials.gov registry record · NA
An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 794
- Enrollment target
NCT04108130 is a NA study that has completed, run by Columbia University. The registered enrollment target is 794 participants.
The verdict
NCT04108130, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 794 participants
- Enrollment target
Study Summary
Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality in surgical patients. National estimates suggest 1,062,000 PPCs per year, with 46,200 deaths, and 4.8 million additional days of hospitalization. The objective of the study is to develop and implement perioperative strategies to eliminate PPCs in abdominal surgery, the field with the largest absolute number of PPCs. We will conduct a randomized controlled pragmatic trial in 750 studied participants. The effectiveness of an individualized perioperative anesthesia-centered bundle will be compared to the usual anesthetic care in patients receiving open abdominal surgery. At the end of this project, the investigators expect to change clinical practice by establishing a new and clinically feasible anesthesia-centered strategy to reduce perioperative lung morbidity. The research will be conducted across 14 US academic centers, and will be funded by the National Institute of Health.
Interventions
- OTHER Preoperative Education
- PROCEDURE Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization
- OTHER Individualization of Neuromuscular Blockade
- PROCEDURE Postoperative Incentive Spirometry
- BEHAVIORAL Postoperative Ambulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 794 participants |
| Start Date | 2020-01-29 |
| Est. Completion | 2023-07-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04108130
The ClinicalTrials.gov registry entry for NCT04108130 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 794 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Preoperative Education is the first listed.
NCT04108130 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04108130 about?
NCT04108130 is a clinical study titled "An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study". Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality in surgical patients. National estimates suggest 1,062,000 PPCs per year, with 46,200 deaths, and 4.8 million additional days of hospitalization. The objective of the study is to develop and implement periopera...
What is the current status of trial NCT04108130?
This trial is currently completed. It is a NA study. The enrollment target is 794 participants. The study started on 2020-01-29. Estimated completion is 2023-07-13.
What interventions are being tested in trial NCT04108130?
The interventions under investigation include: Preoperative Education (OTHER), Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization (PROCEDURE), Individualization of Neuromuscular Blockade (OTHER), Postoperative Incentive Spirometry (PROCEDURE), Postoperative Ambulation (BEHAVIORAL).
Who is sponsoring clinical trial NCT04108130?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
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