Post-operative pulmonary complications (PPCs) are conditions affecting the respiratory tract that cause problems for patients after surgery. They have a major effect on patient mortality, and have significant health care costs. National estimates suggest that they may cause more than 45,000 deaths per year, and lead to nearly 5 million additional days of hospitalization per year.
Although these complications are as significant and lethal as cardiac complications, research into PPCs has been limited. Recently, several groups (including us) have suggested a crucial role of anesthesia-related interventions to reduce PPCs. These interventions include ventilation strategies and the use of neuromuscular blocking agents.
These new strategies seem promising, but we need solid research to demonstrate their effectiveness.
The PRIME-AIR study (“Positive end-expiratory pressure, Recruitment, Incentive spirometry, Muscle relaxant optimization, preoperative Education, postoperative early Ambulation, Individualized, and Reinforced”) is a prospective multi-center randomized controlled pragmatic trial, with a blinded assessor, to compare PPC outcomes of patients with an individualized anesthetic-centered intervention (including individualized mechanical ventilation positive end-expiratory pressure (PEEP) management to maximize respiratory system compliance and minimize driving pressures, a neuromuscular agent and subsequent reversal, and post-operative lung expansion and early mobilization) versus usual care.
The PRIME-AIR study will enroll up to 750 patients undergoing open abdominal surgery (abdominal surgery is the field with the largest absolute number of PPCs). Our hypothesis is that the intervention bundle will reduce the rate of PPCs. This will be determined using a previously published 5-point scale based on the most serious PPC during the first seven days after surgery.
Participating sites:
- Clinical Coordinating Center
- PIs: Dr. Marcos Vidal Melo, Dr. Ana Fernandez-Bustamante
- Data Coordinating Center
- PI: Dr. Robert Parker
- Beth Israel Deaconess Medical Center
- PI: Dr. Baluchundhar Subramaniam
- Brigham and Women’s Hospital
- PI: Dr. Gyorgy Frendyl
- Columbia University Medical Center
- PI: Dr. Marcos Vidal Melo
- Cleveland Clinic
- PI: Dr. Marcelo Gama de Abreu
- Duke University
- PI: Dr. Loreta Grecu
- Massachusetts General Hospital
- PI: Dr. Oluwaseun Johnson-Akeju
- Mayo Clinic
- PIs: Dr. Juraj Sprung, Dr. Toby Weingarten
- Memorial Sloan Kettering
- PI: Dr. David Amar, Dr. Dawn Desiderio
- Montefiore Medical Center
- PI: Dr. Matthias Eikermann
- Northwestern University
- PI: Dr. Ravindra Alok Gupta
- Stanford University
- PI: Dr. Pedro Tanaka
- University of California, San Francisco
- PIs: Dr. Jae-Woo Lee, Dr. Lee-Lynn Chen
- University of Colorado
- PIs: Dr. Ana Fernandez-Bustamante, Dr. David J. Douin
- University of Massachusetts Medical Center
- PI: Dr. Guido Musch
- University of Miami
- PI: Dr. Jadelis Giquel
- University of Nebraska Medical Center
- PI: Dr. Karsten Bartels
- University of Rochester Medical Center
- PI: Dr. Suzanne Karan