An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study
Completed · Not applicable
Conditions studied: Postoperative Pulmonary Complications
In brief
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.
Key facts
- Study ID
- NCT04108130
- Run by
- Columbia University
- People needed
- 794
- Starts
- 2020-01-29
- Expected to finish
- 2023-07-13
- Last updated by the study team
- 2025-10-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults (>=18 years) scheduled for elective surgery with expected duration >=2 hours
- Open abdominal surgery including: gastric, biliary, pancreatic, hepatic, major bowel, ovarian, renal tract, bladder, prostatic, radical hysterectomy, and pelvic exenteration
- Intermediate or high risk of PPCs defined by an ARISCAT (Assess Respiratory Risk in Surgical Patients in Catalonia Score) risk score>=26
You may not qualify if…
- Inability or refusal to provide consent
- Inability or significant difficulty to perform any study interventions, including incentive spirometry, ambulation and/or maintaining follow-up contact with study personnel for up to 90 days after the date of surgery.
- Participation in any interventional research study within 30 days of the time of the study.
- Previous surgery within 30 days prior to this study.
- Pregnancy
- Emergency surgery
- Severe obesity (above Class I, BMI>=35 kg/m2)
- Significant lung disease: any diagnosed or treated respiratory condition that (a) requires home oxygen therapy or non-invasive ventilation (except nocturnal treatment of sleep apnea without supplemental oxygen), (b) severely limits exercise tolerance to <4 metabolic equivalents (METs) (e.g., patients unable to do light housework, walk flat at 4 miles/h or climb one flight of stairs), (c) required previous lung surgery, or (d) includes presence of severe pulmonary emphysema or bullae
- Significant heart disease: cardiac conditions that limit exercise tolerance to <4 METs
- Renal failure: peritoneal or hemodialysis requirement or preoperative creatinine >=2 mg/dL
- Neuromuscular disease that impairs ability to ventilate without assistance
- Severe chronic liver disease (Child-Turcotte-Pugh Score >9, Appendix I)
- Sepsis
- Malignancy or other irreversible condition for which 6-month mortality is estimated >=20%
- Bone marrow transplant
Where it is running
- University of California - San Francisco — San Francisco, California, United States
- Stanford University — Stanford, California, United States
- University of Colorado, Anschutz Medical Campus — Aurora, Colorado, United States
- South Florida Veterans Affairs Foundation for Research and Education, Inc. — Miami, Florida, United States
- Northwestern University — Evanston, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Hospital — Boston, Massachusetts, United States
- Univerisity of Massachusetts Amherst Center — Worcester, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Columbia University Medical Center — New York, New York, United States
- Memorial Sloan Kettering — New York, New York, United States
- University of Rochester — Rochester, New York, United States
- Montefiore Hospital — The Bronx, New York, United States
- Duke University — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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