At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Comparison of Mechanical Ventilation With Low and High Tidal Volumes in Acute Spinal Cord Injury: A Pilot Randomized Comparative Effectiveness Trial
In Brief
A clinical study evaluating High tidal volume and Low tidal volume for Spinal Cord Injuries. Completed, enrolled 31 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.