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Ventilation Strategies for Acute Respiratory Failure (GENIE-Vent Trial)

N/A
Recruiting
Led By Elias H Pratt, 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
No Placebo-Only Group

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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study enrollment until hospital discharge or death, whichever comes first, up to 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Protocol fidelity rate
Secondary study objectives
Duration of ECMO
Duration of Hospital admission
Duration of ICU admission
+4 more

Awards & Highlights

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

Trial Design

2Treatment groups
Active Control
Group I: Ultra-Lung Protective VentilationActive Control1 Intervention
Group II: Standard-Lung Protective VentilationActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,453 Previous Clinical Trials
2,971,674 Total Patients Enrolled
Elias H Pratt, MDPrincipal InvestigatorDuke University
Christopher E. Cox, MDPrincipal InvestigatorDuke University

Media Library

Standard-Lung Protective Ventilation Clinical Trial Eligibility Overview. Trial Name: NCT05708365 — N/A
Acute Respiratory Distress Syndrome Research Study Groups: Ultra-Lung Protective Ventilation, Standard-Lung Protective Ventilation
Acute Respiratory Distress Syndrome Clinical Trial 2023: Standard-Lung Protective Ventilation Highlights & Side Effects. Trial Name: NCT05708365 — N/A
Standard-Lung Protective Ventilation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05708365 — N/A
~7 spots leftby Nov 2025
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