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

NCT04108130 | Completed Results

• 3 other identifiers: AAAT9106HL1401775UH3HL140177-03
• Study Type: interventional
• Target: 794
• Locations: 1 country
• Sites: 16

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number and Severity of Postoperative Pulmonary Complications Between Participant Groups

  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 Outcomes (12)

• Number of Participants With Grade 1 and 2 Postoperative Pulmonary Complications

  Postoperative Days 0 through 7

• Number of Participants With Grade 3 and 4 Postoperative Pulmonary Complications

  Postoperative Days 7, 30, and 90

• Number of Participants With Hypoxemia by Postoperative Day 7

  Postoperative Days 0 through 7

• Number of Participants With Atelectasis by Postoperative Day 7

  Days 0 through 7 after the day of surgery

• Number of Participants With Pneumonia (Suspected and Proved) by Postoperative Day 7

  Days 0 through 7

Study Arms (2)

Usual Care

NO INTERVENTION

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

Intervention

EXPERIMENTAL

This arm will receive the bundle of interventions.

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

Interventions

Preoperative Education OTHER

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

Intervention

Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization PROCEDURE

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

Intervention

Individualization of Neuromuscular Blockade OTHER

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

Intervention

Postoperative Incentive Spirometry PROCEDURE

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.

Intervention

Postoperative Ambulation BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (16)

University of California - San Francisco

San Francisco, California, 94115, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

South Florida Veterans Affairs Foundation for Research and Education, Inc.

Miami, Florida, 33125, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Hospital

Boston, Massachusetts, 02215, United States

Location

Univerisity of Massachusetts Amherst Center

Worcester, Massachusetts, 01655, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Montefiore Hospital

The Bronx, New York, 10467, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Related Publications (11)

• PROVE Network Investigators for the Clinical Trial Network of the European Society of Anaesthesiology; Hemmes SN, Gama de Abreu M, Pelosi P, Schultz MJ. High versus low positive end-expiratory pressure during general anaesthesia for open abdominal surgery (PROVHILO trial): a multicentre randomised controlled trial. Lancet. 2014 Aug 9;384(9942):495-503. doi: 10.1016/S0140-6736(14)60416-5. Epub 2014 Jun 2.

  PMID: 24894577 BACKGROUND

• Writing Committee for the PROBESE Collaborative Group of the PROtective VEntilation Network (PROVEnet) for the Clinical Trial Network of the European Society of Anaesthesiology; Bluth T, Serpa Neto A, Schultz MJ, Pelosi P, Gama de Abreu M; PROBESE Collaborative Group; Bluth T, Bobek I, Canet JC, Cinnella G, de Baerdemaeker L, Gama de Abreu M, Gregoretti C, Hedenstierna G, Hemmes SNT, Hiesmayr M, Hollmann MW, Jaber S, Laffey J, Licker MJ, Markstaller K, Matot I, Mills GH, Mulier JP, Pelosi P, Putensen C, Rossaint R, Schmitt J, Schultz MJ, Senturk M, Serpa Neto A, Severgnini P, Sprung J, Vidal Melo MF, Wrigge H. Effect of Intraoperative High Positive End-Expiratory Pressure (PEEP) With Recruitment Maneuvers vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients: A Randomized Clinical Trial. JAMA. 2019 Jun 18;321(23):2292-2305. doi: 10.1001/jama.2019.7505.

  PMID: 31157366 BACKGROUND

• Williams EC, Motta-Ribeiro GC, Vidal Melo MF. Driving Pressure and Transpulmonary Pressure: How Do We Guide Safe Mechanical Ventilation? Anesthesiology. 2019 Jul;131(1):155-163. doi: 10.1097/ALN.0000000000002731.

  PMID: 31094753 BACKGROUND

• Ladha K, Vidal Melo MF, McLean DJ, Wanderer JP, Grabitz SD, Kurth T, Eikermann M. Intraoperative protective mechanical ventilation and risk of postoperative respiratory complications: hospital based registry study. BMJ. 2015 Jul 14;351:h3646. doi: 10.1136/bmj.h3646.

  PMID: 26174419 BACKGROUND

• Wanderer JP, Ehrenfeld JM, Epstein RH, Kor DJ, Bartz RR, Fernandez-Bustamante A, Vidal Melo MF, Blum JM. Temporal trends and current practice patterns for intraoperative ventilation at U.S. academic medical centers: a retrospective study. BMC Anesthesiol. 2015 Mar 28;15:40. doi: 10.1186/s12871-015-0010-3. eCollection 2015.

  PMID: 25852301 BACKGROUND

• de Jong MAC, Ladha KS, Vidal Melo MF, Staehr-Rye AK, Bittner EA, Kurth T, Eikermann M. Differential Effects of Intraoperative Positive End-expiratory Pressure (PEEP) on Respiratory Outcome in Major Abdominal Surgery Versus Craniotomy. Ann Surg. 2016 Aug;264(2):362-369. doi: 10.1097/SLA.0000000000001499.

  PMID: 26496082 BACKGROUND

• Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.

  PMID: 23902482 BACKGROUND

• Ferrando C, Soro M, Unzueta C, Suarez-Sipmann F, Canet J, Librero J, Pozo N, Peiro S, Llombart A, Leon I, India I, Aldecoa C, Diaz-Cambronero O, Pestana D, Redondo FJ, Garutti I, Balust J, Garcia JI, Ibanez M, Granell M, Rodriguez A, Gallego L, de la Matta M, Gonzalez R, Brunelli A, Garcia J, Rovira L, Barrios F, Torres V, Hernandez S, Gracia E, Gine M, Garcia M, Garcia N, Miguel L, Sanchez S, Pineiro P, Pujol R, Garcia-Del-Valle S, Valdivia J, Hernandez MJ, Padron O, Colas A, Puig J, Azparren G, Tusman G, Villar J, Belda J; Individualized PeRioperative Open-lung VEntilation (iPROVE) Network. Individualised perioperative open-lung approach versus standard protective ventilation in abdominal surgery (iPROVE): a randomised controlled trial. Lancet Respir Med. 2018 Mar;6(3):193-203. doi: 10.1016/S2213-2600(18)30024-9. Epub 2018 Jan 19.

  PMID: 29371130 BACKGROUND

• Brandao JC, Lessa MA, Motta-Ribeiro G, Hashimoto S, Paula LF, Torsani V, Le L, Bao X, Eikermann M, Dahl DM, Deng H, Tabatabaei S, Amato MBP, Vidal Melo MF. Global and Regional Respiratory Mechanics During Robotic-Assisted Laparoscopic Surgery: A Randomized Study. Anesth Analg. 2019 Dec;129(6):1564-1573. doi: 10.1213/ANE.0000000000004289.

  PMID: 31743177 BACKGROUND

• Fernandez-Bustamante A, Parker RA, Frendl G, Lee JW, Nagrebetsky A, Grecu L, Amar D, Tanaka P, Sprung J, Gupta RA, Subramanian B, Giquel J, Eikermann M, Musch G, Nadler JW, Gama de Abreu M, Bartels K, Grover M, Chen LL, Sparling J, Douin DJ, Weingarten T, Wagener G, Thompson BT, Vidal Melo MF; Perioperative Research Network (PRN) Investigators. Perioperative lung expansion and pulmonary outcomes after open abdominal surgery versus usual care in the USA (PRIME-AIR): a multicentre, randomised, controlled, phase 3 trial. Lancet Respir Med. 2025 May;13(5):447-459. doi: 10.1016/S2213-2600(25)00040-2. Epub 2025 Feb 25.

  PMID: 40020692 DERIVED

• Fernandez-Bustamante A, Parker RA, Sprung J, Eikermann M, Gama de Abreu M, Ferrando C, Thompson BT, Vidal Melo MF. An anesthesia-centered bundle to reduce postoperative pulmonary complications: The PRIME-AIR study protocol. PLoS One. 2023 Apr 6;18(4):e0283748. doi: 10.1371/journal.pone.0283748. eCollection 2023.

  PMID: 37023031 DERIVED

MeSH Terms

Interventions

Positive-Pressure Respiration

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Dr. Marcos F. Vidal Melo
• Organization: Columbia University Medical Center

mv2869@cumc.columbia.edu

2123424799

Study Officials

• Marcos F Vidal Melo, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 27, 2019
• Study Start: January 29, 2020
• Primary Completion: July 13, 2023
• Study Completion: July 13, 2023
• Last Updated: October 6, 2025
• Results First Posted: July 4, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After conclusion of the study, planned for 5 years.
• Access Criteria: According to the NIH/NHLBI access policies.

Locations

US (16)