NCT04912583

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

Completed NA Results posted Last updated 15 July 2025

What this trial tests

NA trial testing High tidal volume in Spinal Cord Injuries in 31 participants. Completed in 27 June 2024.

Timeline

17 December 2021

Primary endpoint
27 June 2024

27 June 2024

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	31
Start date	17 December 2021
Primary completion	27 June 2024
Estimated completion	27 June 2024
Sites	2 locations across United States

Drugs / interventions tested

• High tidal volume
• Low tidal volume

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Episodes of Pneumonia Primary · From the time of enrollment to time of discharge from hospital (about 6 weeks)

The primary outcome is pneumonia episodes with evidence of new or progressive and persistent infiltrate on chest radiograph plus 2 of the following abnormal white blood cell count, presence of fever or hyperthermia, purulent sputum, and deterioration in gas exchange. Any new pneumonia episodes which meet the above criteria and developed 48 hours after achieving target tidal volume will be recorded.

Group	Value	95% CI
High Tidal Volume	.13	± .35
Low Tidal Volume	.4	± .5

Feasibility as Assessed by Recruitment Rate Secondary · At the time of consent (within 48 hours of hospital admission)

Recruitment rate is the proportion of eligible people who provide consent.

Group	Value	95% CI
All Subjects Screened	31

Feasibility as Assessed by Adherence Rate Secondary · At the time of start of intervention (within 48 hours of hospital admission)

Adherence rate is the proportion of participants in each group who receive the assigned intervention per protocol.

Group	Value	95% CI
High Tidal Volume	11
Low Tidal Volume	13

Feasibility as Assessed by Retention Rate Secondary · at the time of discharge from hospital (about 6 weeks after admission)

Retention rate is the number of participants in each group who complete all study procedures.

Group	Value	95% CI
High Tidal Volume	15
Low Tidal Volume	15

Feasibility as Assessed by Number of Participants With Missing Data Secondary · From the time of enrollment to time of discharge from hospital (about 6 weeks)

Group	Value	95% CI
Low Tidal Volume	0
High Tidal Volume	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From the time of enrollment to time of discharge from hospital (about 6 weeks). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

High Tidal Volume

Serious: 0/15 (0%)

Deaths: 0/15

Low Tidal Volume

Serious: 1/15 (7%)

Deaths: 1/15

Serious adverse events (1 terms)

Reaction	System	High Tidal Volume	Low Tidal Volume
Cardiac Arrest	Cardiac disorders	—	—

Other adverse events (15 terms — click to expand)

Reaction	System	High Tidal Volume	Low Tidal Volume
Urinary tract infection	Renal and urinary disorders	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—
Pneumonia after 48 hours of admission	Respiratory, thoracic and mediastinal disorders	—	—
Sacral Wound Infection	Infections and infestations	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Mucus plug, which required a transfer	Respiratory, thoracic and mediastinal disorders	—	—
Bronchitis/Tracheitis	Respiratory, thoracic and mediastinal disorders	—	—
Sepsis	Infections and infestations	—	—
Deep Vein Thrombosis	Vascular disorders	—	—
Prostatitis	Reproductive system and breast disorders	—	—
Vaginal Infection	Reproductive system and breast disorders	—	—
Atelectasis requiring intervention	Respiratory, thoracic and mediastinal disorders	—	—
COVID	General disorders	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—
hemoptysis	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Cardiac Arrest.

Data from ClinicalTrials.gov NCT04912583 adverse events section.

Sponsor's own 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.

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Established and Emerging Therapies in Acute Spinal Cord Injury.
   Gadot R, Smith DN, Prablek M, Grochmal JK, et al · · 2022 · cited 19× · PMID 35793931 · DOI 10.14245/ns.2244176.088