MedTrace Logo

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

NCT04912583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-07-15

Study results available
· View outcomes & findings →

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.

Conditions

  • Spinal Cord Injuries

Interventions

DEVICE

High tidal volume

A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.

DEVICE

Low tidal volume

A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.

Sponsors & Collaborators

  • TIRR Memorial Hermann

    collaborator OTHER

  • Craig Hospital

    collaborator OTHER

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH

  • The Craig H. Neilsen Foundation

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Radha Korupolu, MD · McGovern Medical School, The University of Texas Health Science Center at Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2024-06-27
Completion
2024-06-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04912583 on ClinicalTrials.gov