Anesthesia-Centered Bundle for Postoperative Pulmonary Complications
(PRIME-AIR Trial)

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen byMarcos F Vidal Melo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Marcos F Vidal Melo, MD

Principal Investigator

Columbia University

Eligibility Criteria

Adults over 18 years old scheduled for elective open abdominal surgery lasting at least 2 hours and at intermediate/high risk of lung complications can join. Exclusions include those with high short-term mortality risk, recent surgeries, pregnancy, severe liver disease or obesity, significant lung/heart diseases, renal failure, neuromuscular issues affecting breathing, or participation in another study recently.

Inclusion Criteria

I am an adult scheduled for a surgery that will last 2 hours or more.

I have had major surgery in my abdomen area.

Intermediate or high risk of PPCs defined by an ARISCAT (Assess Respiratory Risk in Surgical Patients in Catalonia Score) risk score>=26

Exclusion Criteria

I currently have sepsis.

You have a serious and life-threatening condition that is not likely to improve within the next 6 months.

I have had a bone marrow transplant.

See 12 more

Treatment Details

Interventions

Individualization of Neuromuscular Blockade (Other)
Intraoperative PEEP Individualization (Procedure)
Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization (Procedure)
Postoperative Ambulation (Behavioral Intervention)
Postoperative Incentive Spirometry (Procedure)
Preoperative Education (Behavioral Intervention)

Trial OverviewThe PRIME-AIR Study is testing a bundle of perioperative strategies against usual care to prevent lung problems after abdominal surgery. This includes pre-op education and exercises; tailored use of PEEP during anesthesia; careful muscle relaxation management; and encouraging post-op walking and breathing exercises.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment5 Interventions

This arm will receive the bundle of interventions.

Group II: Usual CareActive Control1 Intervention

Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.