Comparing two ventilation modes to reduce diaphragm atrophy in intubated patients
A Phase III Randomized Trial Comparing the Effects of Volume Support and Assist Control Mode Ventilation on Ventilator-Free Days and Diaphragmatic Atrophy
This study is testing if using a different breathing support method can help intubated patients avoid diaphragm problems and spend less time on a ventilator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 468 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT03901924 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of volume support mode versus assist control mode ventilation on ventilator-free days and diaphragmatic atrophy in patients who have been intubated for less than 36 hours. It focuses on the complications associated with ventilator-induced diaphragmatic dysfunction (VIDD), which can lead to prolonged ICU stays and increased reintubation rates. The hypothesis is that early initiation of support mode ventilation will result in fewer complications and less diaphragmatic atrophy compared to controlled mode ventilation. The study will involve a randomized trial design to compare these two ventilation strategies.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been intubated and mechanically ventilated for less than 36 hours.
Not a fit: Patients with a history of diaphragmatic paralysis, neuromuscular disease, or those expected to be liberated from the ventilator in less than 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery outcomes for patients requiring mechanical ventilation by reducing diaphragmatic atrophy.
How similar studies have performed: Observational studies suggest that different ventilation modes can impact diaphragmatic atrophy, but this specific approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: subjects \> 18 years of age that have been intubated and mechanically ventilated for \< 36 hours at the time of screening will be eligible for enrollment Exclusion Criteria: 1. pregnancy 2. cardiopulmonary arrest 3. history of diaphragmatic paralysis or neuromuscular disease 4. chronic obstructive pulmonary disease (COPD) or asthma exacerbation with evidence of auto-PEEPing requiring intubation 5. neuromuscular blockade 6. expectation to be liberated from ventilator in \< 24 hours 7. history of mechanical ventilation in the last 6 months 8. presence of tracheostomy 9. high cervical spine injury
Where this trial is running
Chicago, Illinois and 1 other locations
- The University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- University of Iowa — Iowa City, Iowa, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Bhakti Patel, MD — University of Chicago
- Study coordinator: Bhakti Patel, MD
- Email: bpatel@bsd.uchicago.edu
- Phone: 773-702-0902
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.