PRIME-AIR study

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 Rochester Medical Center
PI: Dr. Suzanne Karan