Comparing two ventilation modes to reduce diaphragm atrophy in intubated patients
Official title: A Phase III Randomized Trial Comparing the Effects of Volume Support and Assist Control Mode Ventilation on Ventilator-Free Days and Diaphragmatic Atrophy
Run by University of Chicago · NCT03901924 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 468 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Status | Recruiting |
| Started | March 4, 2019 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT03901924 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old who have been intubated and mechanically ventilated for less than 36 hours.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Observational studies suggest that different ventilation modes can impact diaphragmatic atrophy, but this specific approach is novel and has not been extensively tested.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Controlled versus standard oxygen therapy for ICU COPD with acute exacerbation
This trial tests whether keeping oxygen levels at 88-92% helps ICU patients with an acute COPD flare more than keeping levels above 94%.
-
ClusterVAP: Multicentre Proteomic Endotyping of Ventilator-Associated Pneumonia
Researchers will test whether proteomic patterns in BAL fluid can identify subgroups of patients with suspected VAP on mechanical ventilation.
-
Using EIT to personalize PEEP during bariatric surgery
This will test whether using electrical impedance tomography (EIT) to set personalized PEEP during laparoscopic bariatric surgery reduces postoperative lung complications compared with a fixed PEEP of 8 cmH2O in adults with obesity.
-
How common pain is in adults on mechanical ventilators in intensive care units
The researchers will measure how often adults on invasive mechanical ventilation in ICUs experience pain and which clinical factors are linked to it.
-
Using lung ultrasound to diagnose ARDS in patients on mechanical ventilation
This study is testing if lung ultrasound can help doctors quickly diagnose ARDS in patients on mechanical ventilation, comparing it to CT scans.
-
Using the Pressure-Muscle Index to avoid excessive ventilator support during pressure support ventilation
This study will try using a Pressure-Muscle Index to find the right amount of pressure support for adults on mechanical ventilation for acute low-oxygen (hypoxemic) respiratory failure.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.