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Procedure

Personalized Mechanical Ventilation for Sepsis

N/A
Recruiting
Led By Marcos F VIdal Melo, MD/PhD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sepsis as defined by the most recent criteria: Life-threatening organ dysfunction caused by a dysregulated host response to infection operationalized by presumed or documented infection and a Sequential [Sepsis-related] Organ Failure Assessment (SOFA) score >= 2 or a change by 2 from the baseline if baseline known to be different from 0
Be older than 18 years old
Must not have
"Air leaks" requiring tube thoracotomy (e.g., pneumothorax, bronchopleural fistula)
Hemodynamic instability, defined as: systolic blood pressure (SBP) < 90 mmHg that is not adequately stabilized by vasopressors or inotropic agents. For these purposes, SBP will not be considered 'adequately stabilized' if the dose of the vasopressor/inotrope has not been stable for at least one hour
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two ways of using a ventilator to help patients with sepsis who need help breathing, to see which works better. It will use CT scans to measure air in the lungs. #medicine #sepsis #ventilator

Who is the study for?
This trial is for adults with sepsis who've been on a ventilator for less than 5 days due to severe lung issues. They must have a SOFA score >=2, indicating organ dysfunction from infection. Excluded are those under 18, pregnant women, patients exposed to other research radiation recently or with unstable blood pressure/oxygen levels, and anyone with conditions that make CT scans risky.
What is being tested?
The study compares two methods of setting positive end-expiratory pressure (PEEP) on ventilators for sepsis patients: one personalized based on individual breathing needs and another standard approach. It aims to determine which method better supports the lungs using CT scan imaging.
What are the potential side effects?
While not directly related to side effects of medication, potential risks include discomfort from ventilation adjustments and exposure to radiation during CT scans used in the evaluation process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have sepsis with significant organ dysfunction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had air leaks in my chest that needed a tube to fix.
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My blood pressure is very low and not stable even with medication.
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My health worsens with basic movement or care activities.
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Squared coefficient of variation of the tidal volumetric strain
Secondary study objectives
Average gas fraction
Average tidal strain
Distribution of aeration categories
+1 more
Other study objectives
Detection of Inflammatory cytokines
Time during mechanical ventilation

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: Group 2: Individualized PEEP (positive end expiratory pressure) StrategyExperimental Treatment1 Intervention
Participants will receive individualized PEEP (positive end-expiratory pressure).
Group II: Group 1: ARDSNetActive Control1 Intervention
Participants will receive standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol.

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,486 Previous Clinical Trials
2,655,240 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,931 Previous Clinical Trials
47,766,696 Total Patients Enrolled
Marcos F VIdal Melo, MD/PhDPrincipal InvestigatorColumbia University

Media Library

PEEP (positive end-expiratory pressure) - maximum (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05977153 — N/A
Ventilator-Induced Lung Injury Research Study Groups: Group 1: ARDSNet, Group 2: Individualized PEEP (positive end expiratory pressure) Strategy
Ventilator-Induced Lung Injury Clinical Trial 2023: PEEP (positive end-expiratory pressure) - maximum Highlights & Side Effects. Trial Name: NCT05977153 — N/A
PEEP (positive end-expiratory pressure) - maximum (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05977153 — N/A
~1 spots leftby Jan 2025
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