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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
Must not have
Sepsis
Bone marrow transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 0, 7, 30, and 90
Awards & highlights
No Placebo-Only Group

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have sepsis.
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I have had a bone marrow transplant.
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I need help to breathe due to a muscle condition.
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My BMI is 35 or higher, indicating severe obesity.
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I require dialysis or my creatinine level is 2 mg/dL or higher.
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My liver disease is not severe (score ≤9).
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I might struggle with following the study's procedures or keeping in touch with the study team for 3 months after surgery.
Select...
I have a serious lung condition that severely limits my daily activities.
Select...
I have had emergency surgery.
Select...
I have heart disease that limits my physical activity.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number and Severity of Postoperative Pulmonary Complications between Participant Groups
Secondary study objectives
All-Cause Postoperative Mortality
Dyspnea
Difference in Fatigue Participant-Reported Outcomes Measurements Information System (PROMIS) scores
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,013 Previous Clinical Trials
13,308,561 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,662,430 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
~130 spots leftby Nov 2025
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