Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 31 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04912583
The ClinicalTrials.gov registry entry for NCT04912583 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which High tidal volume is the first listed.
NCT04912583 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.