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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have sepsis with significant organ dysfunction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Squared coefficient of variation of the tidal volumetric strain
Secondary outcome measures
Average gas fraction
Average tidal strain
Distribution of aeration categories
+1 moreOther outcome measures
Detection of Inflammatory cytokines
Time during mechanical ventilation
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.
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,447,247 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,852,112 Total Patients Enrolled
Marcos F VIdal Melo, MD/PhDPrincipal InvestigatorColumbia University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any health conditions that could affect imaging tests.I have had air leaks in my chest that needed a tube to fix.I have sepsis with significant organ dysfunction.You have problems with your heart or breathing that get worse when you have to pause your breathing for 20 seconds. This will be checked by asking you to pause your breathing before moving you.My health worsens with basic movement or care activities.My blood pressure is very low and not stable even with medication.I don't have any health issues that would make it unsafe for me to be moved for a CT scan.You have a very high body mass index, which means you are extremely overweight.I am under 18 years old.If your blood oxygen level is very low even when you are given a lot of oxygen.You have been in other research studies involving radiation, or we don't know your history of radiation exposure.I was put on a ventilator no more than 5 days ago.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1: ARDSNet
- Group 2: Group 2: Individualized PEEP (positive end expiratory pressure) Strategy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollees being accepted in this medical experiment at the present time?
"Indeed, the information posted on clinicaltrials.gov suggests that this medical trial is actively recruiting individuals to participate. This study was first publicized on May 10th 2023 and recently modified on July 28th of the same year. Currently, one site needs a total of 12 participants in order to move forward with their research efforts."
Answered by AI
What is the current scale of enrollment for this research endeavor?
"Affirmative. According to clinicaltrials.gov, the research trial was initially posted on May 10th 2023 and last modified on July 28th 2023. Presently, 12 participants are needed for this study at a single location."
Answered by AI
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