Evidence map›Paper›PMID 37023031›Full record

ArticlePloS one2023

An anesthesia-centered bundle to reduce postoperative pulmonary complications: The PRIME-AIR study protocol.

Ana Fernandez-Bustamante, Robert A Parker, Juraj Sprung, Matthias Eikermann, Marcelo Gama de Abreu, Carlos Ferrando, B Taylor Thompson, Marcos F Vidal Melo

3 registry-linked trialsAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04108130 nacompletednot on this map

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

TypeinterventionalSponsorColumbia UniversityRan2020 to 2023Enrolled794ConditionsPostoperative Pulmonary ComplicationsArmsPreoperative Education, Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization, Individualization of Neuromuscular Blockade, Postoperative Incentive Spirometry, Postoperative Ambulation
NCT06239831 recruitingnot on this map

Postoperative Respiratory and Activity Monitoring

TypeobservationalSponsorUniversity of Colorado, DenverRan2022 to 2026Enrolled30ConditionsHypoventilation, Hypoxemia, Postoperative Pulmonary ComplicationsArmsExSpiron and ActivPAL Monitors
NCT07728214 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Reminder-enhanced Incentive Spirometry Evaluation (RISE)

TypeinterventionalSponsorUniversity of Colorado, DenverRan2026 to 2029Enrolled88ConditionsHypoxemiaArmsAlarms ON
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Ana Fernandez-BustamanteDepartment of Anesthesiology, University of Colorado School of Medicine, Aurora, CO, United States of America.ORCID 0000-0002-2996-7704
Robert A ParkerBiostatistics Center, Massachusetts General Hospital, Department of Medicine, Harvard Medical School, Boston, MA, United States of America.
Juraj SprungDepartment of Anesthesiology and Perioperative Medicine, Mayo Clinic, Rochester, MN, United States of America.
Matthias EikermannDepartment of Anesthesiology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, United States of America.
Marcelo Gama de AbreuDepartment of Intensive Care and Resuscitation, Anesthesiology Institute, Cleveland Clinic, Cleveland, OH, United States of America.ORCID 0000-0002-3554-883X
Carlos FerrandoDepartment of Anesthesiology and Intensive Care, Hospital Clínic Institut D'investigació August Pi i Sunyer, Barcelona, Spain.ORCID 0000-0002-1907-5323
B Taylor ThompsonDivision of Pulmonary and Critical Care, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA, United States of America.
Marcos F Vidal MeloDepartment of Anesthesiology, Columbia University Irving Medical Center, New York, NY, United States of America.

Funding

1/2: An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR StudyUH3HL140177 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI FERNANDEZ-BUSTAMANTE, ANA, VIDAL MELO, MARCOS F · 2020 to 2023
$6.6M
2/2: An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study.U24HL140109 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI PARKER, ROBERT A. · 2019 to 2023
$2.3M
NHLBI NIH HHS U24 HL140109NHLBI NIH HHS UH3 HL140177
6 · The paper itself

Abstract

backgroundPostoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality after open abdominal surgery. Optimized perioperative lung expansion may minimize the synergistic factors responsible for the multiple-hit perioperative pulmonary dysfunction. This ongoing study will assess whether an anesthesia-centered bundle focused on perioperative lung expansion results in decreased incidence and severity of PPCs after open abdominal surgery.

methodsProspective multicenter randomized controlled pragmatic trial in 750 adult patients with at least moderate risk for PPCs undergoing prolonged (≥2 hour) open abdominal surgery. Participants are randomized to receive either a bundle intervention focused on perioperative lung expansion or usual care. The bundle intervention includes preoperative patient education, intraoperative protective ventilation with individualized positive end-expiratory pressure to maximize respiratory system compliance, optimized neuromuscular blockade and reversal management, and postoperative incentive spirometry and early mobilization. Primary outcome is the distribution of the highest PPC severity by postoperative day 7. Secondary outcomes include the proportion of participants with: PPC grades 1-2 through POD 7; PPC grades 3-4 through POD 7, 30 and 90; intraoperative hypoxemia, rescue recruitment maneuvers, or cardiovascular events; and any major extrapulmonary postoperative complications. Additional secondary and exploratory outcomes include individual PPCs by POD 7, length of postoperative oxygen therapy or other respiratory support, hospital resource use parameters, Patient-Reported Outcomes Measurements (PROMIS®) questionnaires for dyspnea and fatigue collected before and at days 7, 30 and 90 after surgery, and plasma concentrations of lung injury biomarkers (IL6, IL-8, RAGE, CC16, Ang-2) analyzed from samples obtained before, end of, and 24 hours after surgery. DISCUSSION: Participant recruitment for this study started January 2020; results are expected in 2024. At the conclusion of this trial, we will determine if this anesthesia-centered strategy focused on perioperative lung expansion reduces lung morbidity and healthcare utilization after open abdominal surgery.

trial registrationClinicalTrial.gov NCT04108130.

Indexed as

AnesthesiaLung DiseasesAdultHumansLungMulticenter Studies as TopicPositive-Pressure RespirationPostoperative ComplicationsPragmatic Clinical Trials as TopicProspective StudiesRandomized Controlled Trials as Topic

Identifiers

PMID37023031
PMCPMC10079125

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.