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

September 16, 2025 updated by: Columbia University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 additional days of hospitalization. Abdominal surgery is the field with the largest absolute number of PPCs. The long-term goal is to develop and implement perioperative strategies to eliminate PPCs. Whereas PPCs are as significant and lethal as cardiac complications, research in the field has received much less attention, and strategies to minimize PPCs are regrettably limited. Recently, the investigators and others have suggested a crucial role of anesthesia related interventions such as ventilatory strategies, and administration and reversal of neuromuscular blocking agents in reducing PPCs. These findings are consistent with the beneficial effects of lung protective ventilation during the adult respiratory distress syndrome (ARDS). While surgical patients differ substantially from ARDS patients as most have no or limited lung injury at the start of surgery, intraoperative anesthetic and abdominal surgery interventions result in lung derecruitment and predispose to or produce direct and indirect, potentially multiple-hit, lung injury. Thus, effective anesthetic strategies aiming at early lung protection in this group of patients are greatly needed. Indeed, the current lack of evidence results in wide and unexplained variability in anesthetic practices creating a major public health issue as some practices within usual care appear to be suboptimal and even potentially injurious. The investigators hypothesize that an anesthesia-centered bundle, based on recent findings and focused on perioperative lung protection, will minimize multiple and synergistic factors responsible for the multiple-hit perioperative pulmonary dysfunction and result in decreased incidence and severity of PPCs. Founded on strong preliminary data, we will leverage a network of US academic centers to study this hypothesis in two aims: Aim 1. To compare the number and severity of PPCs in participants receiving an individualized perioperative anesthesia-centered bundle to those in participants receiving usual anesthetic care during open abdominal surgery. For this, the investigators propose to conduct a prospective multicenter randomized controlled pragmatic trial with a blinded assessor in a total of 750 studied participants. The bundle will consist of optimal mechanical ventilation comprising individualized positive end-expiratory pressure to maximize respiratory system compliance and minimize driving pressures, individualized use of neuromuscular blocking agents and their reversal, and postoperative lung expansion and early mobilization; Aim 2. To assess the effect of the proposed bundle on plasma levels of lung injury biomarkers. The investigators theorize that our intervention will minimize overinflation and atelectasis reducing plasma levels of biomarkers of lung inflammatory, epithelial, and endothelial injury. Such mechanistic insights will facilitate bundle dissemination and support adoption as it has for lung protective ventilation for ARDS. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
794

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94115
        • University of California - San Francisco
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado, Anschutz Medical Campus
    • Florida
      • Miami, Florida, United States, 33125
        • South Florida Veterans Affairs Foundation for Research and Education, Inc.
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Northwestern University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Hospital
      • Worcester, Massachusetts, United States, 01655
        • Univerisity of Massachusetts Amherst Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University Of Nebraska Medical Center
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical center
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering
      • Rochester, New York, United States, 14642
        • University of Rochester
      • The Bronx, New York, United States, 10467
        • Montefiore Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Usual Care
Participants in this arm will receive usual anesthetic and postoperative care as provided in each site.
Experimental: Intervention
This arm will receive the bundle of 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and Severity of Postoperative Pulmonary Complications Between Participant Groups
Time Frame: Postoperative Days 0 through 7
The distribution of the number and severity of accumulated post-operative pulmonary complications (PPCs) between the control and intervention groups during the first 7 days after surgery.
Postoperative Days 0 through 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: Days 0 through 7, 30, and 90
Number of days the participant has spent in the hospital since the day of the surgery.
Days 0 through 7, 30, and 90
Number of Participants With Grade 1 and 2 Postoperative Pulmonary Complications
Time Frame: Postoperative Days 0 through 7
Individual grade 3 and 4 postoperative pulmonary complications within 7 days after the day of the surgery.
Postoperative Days 0 through 7
Number of Participants With Grade 3 and 4 Postoperative Pulmonary Complications
Time Frame: Postoperative Days 7, 30, and 90
Individual grade 3 and 4 postoperative pulmonary complications within 7, 30, and 90 days after the day of the surgery.
Postoperative Days 7, 30, and 90
Number of Participants With Hypoxemia by Postoperative Day 7
Time Frame: Postoperative Days 0 through 7
Presence of any hypoxemia (as defined in PPC grade 1 and 2) within 7 days after the day of the surgery.
Postoperative Days 0 through 7
Number of Participants With Atelectasis by Postoperative Day 7
Time Frame: Days 0 through 7 after the day of surgery
Presence of atelectasis (radiological confirmation + either temperature >37.5°C or abnormal lung symptoms/signs) by day 7 after the date of surgery.
Days 0 through 7 after the day of surgery
Number of Participants With Pneumonia (Suspected and Proved) by Postoperative Day 7
Time Frame: Days 0 through 7
Incidence of suspected (radiological evidence without bacteriological confirmation) and proved (radiological evidence and documentation of pathological organism) pneumonia by day 7 after the date of surgery.
Days 0 through 7
Number of Participants With Ventilatory Dependence or Failure by Postoperative Day 7
Time Frame: Days 0 through 7
Number of participants with ventilatory dependence (Grade 3, non-invasive or invasive ventilation < 48h) or failure (Grade 4, postoperative non-invasive or invasive ventilation dependence ≥ 48h) by day 7 after the date of surgery.
Days 0 through 7
Length of Postoperative Oxygen Support
Time Frame: Up to 7 days post-surgery
Number of time (hours or days) spent in the postoperative oxygen therapy or other respiratory support
Up to 7 days post-surgery
Number of Participants With Both Intraoperative Hypoxemia and Rescue Recruitment Maneuvers
Time Frame: Day 0
The incidence of both intraoperative hypoxemia (SpO2 < 85%) and rescue recruitment maneuvers during surgery. Received unplanned RM or PEEP titrations or adjustments during surgery for oxygenation or ventilation rescue.
Day 0
Number of Participants With Intraoperative Cardiovascular Events
Time Frame: Day 0
Number of participants with hypotension, bradycardia, tachycardia, arrhythmias, new ST-segment changes and cardiac arrest
Day 0
Number of Participants With Other Hospital Readmission(s) After Initial Discharge
Time Frame: After the date of discharge to day 90
The number of participants with hospital readmission(s), other than to the Intensive Care Unit, if admitted.
After the date of discharge to day 90
Number of Participants With Any Major Extrapulmonary Complications
Time Frame: Days 0 to 7
Number of participants with arrhythmia, paralytic ileus, surgical site infection, infection (source uncertain), acute renal failure, and systemic inflammatory response syndrome.
Days 0 to 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marcos F Vidal Melo, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAT9106
  • HL140177 (Other Identifier: MGH)
  • 5UH3HL140177-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In compliance with with the NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information (Notice Number NOT-OD-16-149) and NIH/NHLBI guidelines, we will submit data and specimens to the NHLBI BioLINCC (The Biologic Specimen and Data Repository Information Coordinating Center) repository, and follow procedures specified in the BioLINCC Handbook. First, list of materials to be submitted including the specimens for the NHLBI biorepository will be created. Then a data redaction plan removing personal identifiers and administrative data will be prepared, recoding low-frequency data values for subject privacy protection. The data set documentation, summary of changes made during redaction, and a summary report will be submitted to the BioLINCC repository following the standard procedures. We will comply with any modifications identified during the BioLINCC repository review, and submit the final material acceptable to the repository.

IPD Sharing Time Frame

After conclusion of the study, planned for 5 years.

IPD Sharing Access Criteria

According to the NIH/NHLBI access policies.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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