An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study
Public ClinicalTrials.gov record NCT04108130. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04108130
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 794 participants
Conditions and interventions
Conditions
Interventions
- Preoperative Education Other
- Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization Procedure
- Individualization of Neuromuscular Blockade Other
- Postoperative Incentive Spirometry Procedure
- Postoperative Ambulation Behavioral
Other · Procedure · Behavioral
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 28, 2020
- Primary completion
- Jul 12, 2023
- Completion
- Jul 12, 2023
- Last update posted
- Oct 5, 2025
2020 – 2023
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California - San Francisco | San Francisco | California | 94115 | — |
| Stanford University | Stanford | California | 94305 | — |
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| South Florida Veterans Affairs Foundation for Research and Education, Inc. | Miami | Florida | 33125 | — |
| Northwestern University | Evanston | Illinois | 60208 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Hospital | Boston | Massachusetts | 02215 | — |
| Univerisity of Massachusetts Amherst Center | Worcester | Massachusetts | 01655 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering | New York | New York | 10065 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Montefiore Hospital | The Bronx | New York | 10467 | — |
| Duke University | Durham | North Carolina | 27710 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04108130, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2025 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04108130 live on ClinicalTrials.gov.