Postoperative Pulmonary ComplicationsPRIME-AIRNCT04108130
An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study
A study testing Preoperative Education, Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization and Individualization of Neuromuscular Blockade in people with Postoperative Pulmonary Complications, run by Columbia University at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pulmonary Complications
- What is being tested?
- Preoperative Education, Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization and Individualization of Neuromuscular Blockade
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 794 participants
- Where
- 16 sitesUnited States
- Study dates
- 29 Jan 2020to 13 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Hospital
Boston, Massachusetts, 02215
Duke University
Durham, North Carolina, 27710
Northwestern University
Evanston, Illinois, 60208
South Florida Veterans Affairs Foundation for Research and Education, Inc.
Miami, Florida, 33125
Columbia University Medical Center
New York, New York, 10032
Memorial Sloan Kettering
New York, New York, 10065
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
University of California - San Francisco
San Francisco, California, 94115
Stanford University
Stanford, California, 94305
Montefiore Hospital
The Bronx, New York, 10467
Univerisity of Massachusetts Amherst Center
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Postoperative Pulmonary Complications
- Being tested
- Preoperative Education, Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization, Individualization of Neuromuscular Blockade, Postoperative Incentive Spirometry, Postoperative Ambulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative EducationOther
Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry.
Intraoperative PEEP (Positive End-Expiratory Pressure) IndividualizationProcedure or surgery
PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver.
Individualization of Neuromuscular BlockadeOther
Administration of neuromuscular blocking agents and their reversal will be done based on established protocol.
Postoperative Incentive SpirometryProcedure or surgery
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.
Postoperative AmbulationBehavioural
Participants will be encouraged to adhere to prescription of early ambulation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Preoperative Education; Procedure: Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization; Other: Individualization of Neuromuscular Blockade; Procedure: Postoperative Incentive Spirometry; Behavioral: Postoperative Ambulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Days 0 through 7
Secondary outcomes (12)
Number of Participants With Grade 1 and 2 Postoperative Pulmonary Complications
Individual grade 3 and 4 postoperative pulmonary complications within 7 days after the day of the surgery.
Measured: Postoperative Days 0 through 7
Number of Participants With Grade 3 and 4 Postoperative Pulmonary Complications
Individual grade 3 and 4 postoperative pulmonary complications within 7, 30, and 90 days after the day of the surgery.
Measured: Postoperative Days 7, 30, and 90
Number of Participants With Hypoxemia by Postoperative Day 7
Presence of any hypoxemia (as defined in PPC grade 1 and 2) within 7 days after the day of the surgery.
Measured: Postoperative Days 0 through 7
Number of Participants With Atelectasis by Postoperative Day 7
Presence of atelectasis (radiological confirmation + either temperature >37.5°C or abnormal lung symptoms/signs) by day 7 after the date of surgery.
Measured: Days 0 through 7 after the day of surgery
Number of Participants With Pneumonia (Suspected and Proved) by Postoperative Day 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.
Measured: Days 0 through 7
Number of Participants With Ventilatory Dependence or Failure by Postoperative Day 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.
Measured: Days 0 through 7
Length of Postoperative Oxygen Support
Number of time (hours or days) spent in the postoperative oxygen therapy or other respiratory support
Measured: Up to 7 days post-surgery
Number of Participants With Both Intraoperative Hypoxemia and Rescue Recruitment Maneuvers
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.
Measured: Day 0
Number of Participants With Intraoperative Cardiovascular Events
Number of participants with hypotension, bradycardia, tachycardia, arrhythmias, new ST-segment changes and cardiac arrest
Measured: Day 0
Length of Hospital Stay
Number of days the participant has spent in the hospital since the day of the surgery.
Measured: Days 0 through 7, 30, and 90
Number of Participants With Other Hospital Readmission(s) After Initial Discharge
The number of participants with hospital readmission(s), other than to the Intensive Care Unit, if admitted.
Measured: After the date of discharge to day 90
Number of Participants With Any Major Extrapulmonary Complications
Number of participants with arrhythmia, paralytic ileus, surgical site infection, infection (source uncertain), acute renal failure, and systemic inflammatory response syndrome.
Measured: Days 0 to 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start29 Jan 2020
- Primary completion13 Jul 2023
- Study completion13 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 794 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Marcos F Vidal Melo, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108130
- Sponsor's protocol ID
- AAAT9106
- Other IDs
- HL140177, 5UH3HL140177-03
- Acronym
- PRIME-AIR
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2019
- Last updated
- 6 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 24894577Writing 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.
PubMed 31157366Williams 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.
PubMed 31094753Ladha 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.
PubMed 26174419Wanderer 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.
PubMed 25852301de 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.
PubMed 26496082Futier 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.
PubMed 23902482Ferrando 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.
PubMed 29371130Brandao 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.
PubMed 31743177Fernandez-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.
PubMed 40020692Fernandez-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.
PubMed 37023031
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study
- ClinicalTrials.gov ID
- NCT04108130
- Acronym / sponsor ID
- PRIME-AIR / AAAT9106
- Conditions
- Postoperative Pulmonary Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 794 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 13 Jul 2023 (actual)
- Study completion
- 13 Jul 2023 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Posted 4 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants in this arm will receive usual anesthetic and postoperative care as provided in each site. |
| Intervention | Experimental | Other: Preoperative Education, Procedure: Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization, Other: Individualization of Neuromuscular Blockade, Procedure: Postoperative Incentive Spirometry, Behavioral: Postoperative AmbulationThis arm will receive the bundle of interventions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative EducationBrochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry. | Other | Intervention |
| Intraoperative PEEP (Positive End-Expiratory Pressure) IndividualizationPEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver. | Procedure or surgery | Intervention |
| Individualization of Neuromuscular BlockadeAdministration of neuromuscular blocking agents and their reversal will be done based on established protocol. | Other | Intervention |
| Postoperative Incentive SpirometryParticipants 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. | Procedure or surgery | Intervention |
| Postoperative AmbulationParticipants will be encouraged to adhere to prescription of early ambulation. | Behavioural | Intervention |
Primary outcome
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.
12 secondary outcomes
Number of Participants With Grade 1 and 2 Postoperative Pulmonary Complications
Time frame: Postoperative Days 0 through 7
Number of Participants With Grade 3 and 4 Postoperative Pulmonary Complications
Time frame: Postoperative Days 7, 30, and 90
Number of Participants With Hypoxemia by Postoperative Day 7
Time frame: 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
Number of Participants With Pneumonia (Suspected and Proved) by Postoperative Day 7
Time frame: Days 0 through 7
Number of Participants With Ventilatory Dependence or Failure by Postoperative Day 7
Time frame: Days 0 through 7
Length of Postoperative Oxygen Support
Time frame: Up to 7 days post-surgery
Number of Participants With Both Intraoperative Hypoxemia and Rescue Recruitment Maneuvers
Time frame: Day 0
Number of Participants With Intraoperative Cardiovascular Events
Time frame: Day 0
Length of Hospital Stay
Time frame: Days 0 through 7, 30, and 90
Number of Participants With Other Hospital Readmission(s) After Initial Discharge
Time frame: After the date of discharge to day 90
Number of Participants With Any Major Extrapulmonary Complications
Time frame: Days 0 to 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24894577PROVE 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.
- Background: PubMed 31157366Writing 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.
- Background: PubMed 31094753Williams 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.
- Background: PubMed 26174419Ladha 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.
- Background: PubMed 25852301Wanderer 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.
- Background: PubMed 26496082de 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.
- Background: PubMed 23902482Futier 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.
- Background: PubMed 29371130Ferrando 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.
- Background: PubMed 31743177Brandao 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.
- Derived from this study: PubMed 40020692Fernandez-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.
- Derived from this study: PubMed 37023031Fernandez-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcos F Vidal Melo, MD principal investigator
Columbia University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Education, Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization and Individualization of Neuromuscular Blockade in people with Postoperative Pulmonary Complications, run by Columbia University at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and Severity of Postoperative Pulmonary Complications Between Participant Groups (time frame: Postoperative Days 0 through 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04108130, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.