Status:
COMPLETED
Comparison of Low and High Tidal Volumes in Acute Spinal Cord Injury
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
TIRR Memorial Hermann
Craig Hospital
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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). Secon...
Detailed Description
Background: Respiratory complications associated with mechanical ventilation (MV) are the leading cause of morbidity and mortality following acute spinal cord injury (SCI). Emerging evidence suggests ...
Eligibility Criteria
Inclusion
- Adult patients ≥ 18 years (Lung volumes and ventilator settings are different for ages \<18 years).
- Acute SCI of duration ≤ four months
- Mechanical ventilation subjects: traumatic or non-traumatic cervical SCI with neurological level C1-C5 admitted to our acute inpatient rehabilitation facility (AIR) on mechanical ventilation
Exclusion
- Severe dysphagia due to concomitant brain stem injury, which increases the risk of pneumonia
- Severe brain injury resulting in dysphagia and inability to follow instructions to perform vital capacity measurements
- ARDS or severe lung disease (required supplemental oxygen or ventilator prior to SCI) at the time of admission (these conditions will not allow patients to randomize because target vt may below)
- Prolonged antibiotics for \> 3 weeks at the time of admission due to infection (e.g., osteomyelitis, epidural abscess, etc.),
- Presence of diaphragmatic pacemaker.
Key Trial Info
Start Date :
December 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04912583
Start Date
December 17 2021
End Date
June 27 2024
Last Update
July 15 2025
Active Locations (2)
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1
Craig Hospital
Englewood, Colorado, United States, 80113
2
TIRR Memorial Hermann
Houston, Texas, United States, 77030