Comparison of Low and High Tidal Volumes in Acute Spinal Cord Injury
Key facts
- Where
- Englewood and Houston, United StatesSee the 2 sites
Where in United States
- Craig HospitalEnglewood, United StatesNo longer taking part
- TIRR Memorial HermannHouston, United StatesNo longer taking part
Trial details
- Who runs it
- The University of Texas Health Science Center, Houston
- Trial code
- NCT04912583
- Record updated
- 15 July 2025
- Original description
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.Read full original descriptionShow less
Comparison of Mechanical Ventilation With Low and High Tidal Volumes in Acute Spinal Cord Injury: A Pilot Randomized Comparative Effectiveness Trial
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.
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; 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.),; Severe brain injury resulting in dysphagia and inability to follow instructions to perform vital capacity measurements; Presence of diaphragmatic pacemaker.