N/A
N=794
An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study
Postoperative Pulmonary Complications
Bottom Line
View on ClinicalTrials.gov: NCT04108130 ↗Enrolled (actual)
794
Serious AEs
8.8%
Results posted
Jul 2025
Primary outcome: Primary: Number and Severity of Postoperative Pulmonary Complications Between Participant Groups — 84; 73; 35; 51 complications
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Preoperative Education (Other); Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization (Procedure); Individualization of Neuromuscular Blockade (Other); Postoperative Incentive Spirometry (Procedure); Postoperative Ambulation (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number and Severity of Postoperative Pulmonary Complications Between Participant Groups |
84; 73; 35; 51; 225; 211 | — |
| SECONDARY Number of Participants With Grade 1 and 2 Postoperative Pulmonary Complications |
260; 262 | — |
| SECONDARY Number of Participants With Grade 3 and 4 Postoperative Pulmonary Complications |
28; 44; 32; 49; 35; 53 | — |
| SECONDARY Number of Participants With Hypoxemia by Postoperative Day 7 |
263; 284 | — |
| SECONDARY Number of Participants With Atelectasis by Postoperative Day 7 |
59; 70 | — |
| SECONDARY Number of Participants With Pneumonia (Suspected and Proved) by Postoperative Day 7 |
18; 28 | — |
| SECONDARY Number of Participants With Ventilatory Dependence or Failure by Postoperative Day 7 |
15; 22 | — |
| SECONDARY Length of Postoperative Oxygen Support |
19.2; 14.6 | — |
| SECONDARY Number of Participants With Both Intraoperative Hypoxemia and Rescue Recruitment Maneuvers |
21; 6 | — |
| SECONDARY Number of Participants With Intraoperative Cardiovascular Events |
18; 21 | — |
| SECONDARY Length of Hospital Stay |
6.8; 7.2 | — |
| SECONDARY Number of Participants With Other Hospital Readmission(s) After Initial Discharge |
0; 0 | — |
| SECONDARY Number of Participants With Any Major Extrapulmonary Complications |
43; 48 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 =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
Data sourced from ClinicalTrials.gov (NCT04108130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.