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Status:

COMPLETED

An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study

Lead Sponsor:

Columbia University

Collaborating Sponsors:

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Postoperative Pulmonary Complications

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 ...

Detailed Description

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 29 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 13 2023

Estimated Enrollment :

794 Patients enrolled

Trial Details

Trial ID

NCT04108130

Start Date

January 29 2020

End Date

July 13 2023

Last Update

October 6 2025

Active Locations (16)

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Page 1 of 4 (16 locations)

1

University of California - San Francisco

San Francisco, California, United States, 94115

2

Stanford University

Stanford, California, United States, 94305

3

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, United States, 80045

4

South Florida Veterans Affairs Foundation for Research and Education, Inc.

Miami, Florida, United States, 33125