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

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.

Conditions

• Postoperative Pulmonary Complications

Interventions

OTHER

Preoperative Education

Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry.

PROCEDURE

Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization

PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver.

OTHER

Individualization of Neuromuscular Blockade

Administration of neuromuscular blocking agents and their reversal will be done based on established protocol.

PROCEDURE

Postoperative Incentive Spirometry

Participants will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until participant freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance.

BEHAVIORAL

Postoperative Ambulation

Participants will be encouraged to adhere to prescription of early ambulation.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Marcos F Vidal Melo, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-29

Primary Completion

2023-07-13

Completion

2023-07-13

Countries

• United States

Study Locations