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NCT04912583 · ClinicalTrials.gov registry record · NA
Comparison of Low and High Tidal Volumes in Acute Spinal Cord Injury
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT04912583: Completed NA study, sponsored by The University of Texas Health Science Center, Houston.
NCT04912583 is a NA study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 31 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04912583, a NA study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
Objective: This study's primary objective is to evaluate the efficacy and feasibility of mechanical ventilation with high vs. low tidal volume (Vt) in people with acute spinal cord injury (SCI). Secondary objectives include a comparison of inflammatory markers between these groups. Study Design: Randomized comparative effectiveness trial Methods: Study population: Adults with acute traumatic SCI on mechanical ventilation (MV). Subjects will be randomized to receive either a lower Vt of 8-10 cc/kg predicted body weight (pbw) or a high Vt of 14-16 ml/kg pbw. Risks and potential Benefits: Risks of study interventions are similar to usual care as proposed tidal volume settings are within the current usual care range. However, people assigned to the lower tidal volume group may have a lower risk of pneumonia and respiratory complications.
Primary Outcome
The primary outcome is pneumonia episodes with evidence of new or progressive and persistent infiltrate on chest radiograph plus 2 of the following abnormal white blood cell count, presence of fever or hyperthermia, purulent sputum, and deterioration in gas exchange. Any new pneumonia episodes which meet the above criteria and developed 48 hours after achieving target tidal volume will be recorded.
Interventions
- DEVICE High tidal volume
- DEVICE Low tidal volume
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2021-12-17 |
| Est. Completion | 2024-06-27 |
| Phase | NA |
What the finished NCT04912583 record still lists
NCT04912583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which High tidal volume is the first listed.
NCT04912583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04912583 about?
NCT04912583 is a clinical study titled "Comparison of Low and High Tidal Volumes in Acute Spinal Cord Injury". Objective: This study's primary objective is to evaluate the efficacy and feasibility of mechanical ventilation with high vs. low tidal volume (Vt) in people with acute spinal cord injury (SCI). Secondary objectives include a comparison of inflammatory markers between these groups. Study Design: Ra...
What is the current status of trial NCT04912583?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2021-12-17. Estimated completion is 2024-06-27.
What interventions are being tested in trial NCT04912583?
The interventions under investigation include: High tidal volume (DEVICE), Low tidal volume (DEVICE).
Who is sponsoring clinical trial NCT04912583?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04912583's enrollment target sits among peer trials
31 1592nd of 2000 higher than 408 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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