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

N/A

Recruiting

Led By Marcos F Vidal Melo, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 0, 7, 30, and 90

Awards & highlights

PRIME-AIR Trial Summary

This trial is testing a new perioperative strategy to reduce pulmonary complications in patients receiving open abdominal surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Potential side effects may involve discomfort from the incentive spirometry (breathing exercise device), challenges with early ambulation (walking soon after surgery), or reactions to individualized PEEP settings which could affect oxygen levels or cause respiratory distress.

PRIME-AIR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have had major surgery in my abdomen area.

PRIME-AIR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 0, 7, 30, and 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 0, 7, 30, and 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 0, 7, 30, and 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number and Severity of Postoperative Pulmonary Complications between Participant Groups

Secondary outcome measures

All-Cause Postoperative Mortality

Dyspnea

Difference in Fatigue Participant-Reported Outcomes Measurements Information System (PROMIS) scores

+10 more

PRIME-AIR Trial Design

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,197,731 Total Patients Enrolled

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,446,509 Total Patients Enrolled

Marcos F Vidal Melo, MDPrincipal InvestigatorColumbia University

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Intraoperative PEEP Individualization Clinical Trial Eligibility Overview. Trial Name: NCT04108130 — N/A

Pulmonary Complications Research Study Groups: Usual Care, Intervention

Pulmonary Complications Clinical Trial 2023: Intraoperative PEEP Individualization Highlights & Side Effects. Trial Name: NCT04108130 — N/A

Intraoperative PEEP Individualization 2023 Treatment Timeline for Medical Study. Trial Name: NCT04108130 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What would be the ultimate goal of this scientific experiment?

"This study is evaluating the Number and Severity of Postoperative Pulmonary Complications, Length of Hospital Stay, Fatigue Patient-Reported Outcomes Measurements Information System (PROMIS) scores, and Dyspnea Patient-Reported Outcomes Measurements Information System (PROMIS) scores between participant groups over a period extending from Postoperative Day 0 to 7. The Fatigue PROMIS scale will measure items on a 5 point Likert-type scale while the Dyspnea PROMIS Scale measures responses with a 4 point Likert type scale. Both scales utilise T-score analysis where lower values"

Answered by AI

In how many different geographic areas is this research taking place?

"14 locations are presently hosting the research, with major cities such as Worcester, Stanford and New york included. For a more convenient trial experience it is advisable to choose the nearest centre for enrollment."

Answered by AI

How many participants have been registered for this clinical trial so far?

"This research necessitates the enrolment of 750 individuals who satisfy specific eligibility criteria. Prospective participants can register at either University of Massachusetts Amherst Center in Worcester, California or Massachusetts General Hospital in Stanford, New york."

Answered by AI

Are there any open spots for participants in this investigation?

"Affirmative. Clinicaltrials.gov showcases that this trial, first published on January 27th 2020, is currently recruiting individuals. 750 participants are to be recruited from 14 distinct medical facilities."

Answered by AI

Recent research and studies

The LancetJournal

High Versus Low Positive End-expiratory Pressure During General Anaesthesia for Open Abdominal Surgery (PROVHILO Trial): A Multicentre Randomised Controlled Trial

“High Versus Low Positive End-expiratory Pressure During General Anaesthesia for Open Abdominal Surgery (PROVHILO Trial): A Multicentre Randomised Controlled Trial”. 2014. “High Versus Low Positive End-expiratory Pressure During General Anaesthesia for Open Abdominal Surgery (PROVHILO Trial): A Multicentre Randomised Controlled Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(14)60416-5.

JamaJournal

Effect of Intraoperative High Positive End-expiratory Pressure (PEEP) with Recruitment Maneuvers Vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients

Writing Committee for the PROBESE Collaborative Group of the PROtective VEntilation Network (PROVEnet) for the Clinical Trial Network of the European Society of Anaesthesiology, Thomas Bluth, Ary Serpa Neto, Marcus J. Schultz, Paolo Pelosi, and Marcelo Gama de Abreu. 2019. “Effect of Intraoperative High Positive End-expiratory Pressure (PEEP) with Recruitment Maneuvers Vs Low PEEP on Postoperative Pulmonary Complications in Obese Patients”. Jama. American Medical Association (AMA). doi:10.1001/jama.2019.7505.

Anesthesia & AnalgesiaJournal

Global and Regional Respiratory Mechanics During Robotic-assisted Laparoscopic Surgery

Brandão, Julio C., Marcos A. Lessa, Gabriel Motta-Ribeiro, Soshi Hashimoto, Luis Felipe Paula, Vinicius Torsani, Linh Le, et al.. 2019. “Global and Regional Respiratory Mechanics During Robotic-assisted Laparoscopic Surgery”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0000000000004289.

AnesthesiologyJournal