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Ventilation Strategies for Acute Respiratory Failure (GENIE-Vent Trial)
N/A
Recruiting
Led By Christopher E. Cox, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Awards & highlights
GENIE-Vent Trial Summary
This trial will study how different ventilator strategies impact the treatment of patients with acute respiratory failure on ECMO. Patients will be put into two groups and assigned different ventilator protocols to compare the effects.
Who is the study for?
This trial is for patients at Duke University Hospital's Medical ICU who are being treated with ECMO, a life-support machine used when the lungs can't provide enough oxygen on their own. There are no specific exclusion criteria, so all such patients may participate.Check my eligibility
What is being tested?
The study compares two ventilator strategies in the ICU: standard-lung protective ventilation and ultra-lung protective ventilation. It aims to see if different protocols affect patient treatment and whether clinicians will adhere to them during ECMO support.See study design
What are the potential side effects?
Since this trial involves standard medical procedures rather than new medications, side effects relate to potential differences in lung management between the two strategies, which could impact breathing comfort and recovery.
GENIE-Vent Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Protocol fidelity rate
Secondary outcome measures
Duration of ECMO
Duration of Hospital admission
Duration of ICU admission
+4 moreGENIE-Vent Trial Design
2Treatment groups
Active Control
Group I: Ultra-Lung Protective VentilationActive Control1 Intervention
Group II: Standard-Lung Protective VentilationActive Control1 Intervention
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,466 Total Patients Enrolled
Christopher E. Cox, MDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Ultra-Lung Protective Ventilation
- Group 2: Standard-Lung Protective Ventilation
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 individuals being accepted to participate in this investigation currently?
"According to the clinicaltrials.gov database, this research is actively looking for volunteers as of March 1st 2023; a date that coincides with its last update on the same day."
Answered by AI
What is the current scope of participants in this clinical trial?
"Confirmed. Clinicaltrials.gov demonstrates that this medical research was first launched on March 1st, 2023 and is still recruiting participants. At present, the trial requires a total of twenty individuals from one single site to join in."
Answered by AI
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