N/A N=30 Randomized Triple-blind Treatment

Comparison of Low and High Tidal Volumes in Acute Spinal Cord Injury

Spinal Cord Injuries

Bottom Line

View on ClinicalTrials.gov: NCT04912583 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Jul 2025

Primary outcome: Primary: Number of Episodes of Pneumonia — .13; .4 episodes of pneumonia

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: High tidal volume (Device); Low tidal volume (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Jun 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Episodes of Pneumonia	.13; .4	—
SECONDARY Feasibility as Assessed by Recruitment Rate	31	—
SECONDARY Feasibility as Assessed by Adherence Rate	11; 13	—
SECONDARY Feasibility as Assessed by Retention Rate	15; 15	—
SECONDARY Feasibility as Assessed by Number of Participants With Missing Data	0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

Adult patients ≥ 18 years (Lung volumes and ventilator settings are different for ages 3 weeks at the time of admission due to infection (e.g., osteomyelitis, epidural abscess, etc.),
Presence of diaphragmatic pacemaker.

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Data sourced from ClinicalTrials.gov (NCT04912583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.