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

NCT04912583 | Completed Results FDA Device

• 2 other identifiers: HSC-MS-21-0222KL2TR003168
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Spinal cord injury; Mechanical ventilation; Pneumonia; Tidal volume

Outcome Measures

Primary Outcomes (1)

• Number of Episodes of Pneumonia

  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.

  From the time of enrollment to time of discharge from hospital (about 6 weeks)

Secondary Outcomes (4)

• Feasibility as Assessed by Recruitment Rate

  At the time of consent (within 48 hours of hospital admission)

• Feasibility as Assessed by Adherence Rate

  At the time of start of intervention (within 48 hours of hospital admission)

• Feasibility as Assessed by Retention Rate

  at the time of discharge from hospital (about 6 weeks after admission)

• Feasibility as Assessed by Number of Participants With Missing Data

  From the time of enrollment to time of discharge from hospital (about 6 weeks)

Other Outcomes (1)

• Number of Respiratory Complications

  From the time of enrollment to the time of discharge from the hospital (about 6 weeks)

Study Arms (2)

High tidal volume

ACTIVE COMPARATOR

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

Device: High tidal volume

Low tidal volume

ACTIVE COMPARATOR

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

Device: Low tidal volume

Interventions

High tidal volume DEVICE

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

High tidal volume

Low tidal volume DEVICE

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

Low tidal volume

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe dysphagia due to concomitant brain stem injury, which increases the risk of pneumonia
• Severe brain injury resulting in dysphagia and inability to follow instructions to perform vital capacity measurements
• 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.),
• Presence of diaphragmatic pacemaker.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• TIRR Memorial Hermann: collaborator
• Craig Hospital: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator
• The Craig H. Neilsen Foundation: collaborator

Study Sites (2)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Hatton GE, Mollett PJ, Du RE, Wei S, Korupolu R, Wade CE, Adams SD, Kao LS. High tidal volume ventilation is associated with ventilator-associated pneumonia in acute cervical spinal cord injury. J Spinal Cord Med. 2021 Sep;44(5):775-781. doi: 10.1080/10790268.2020.1722936. Epub 2020 Feb 11.

  PMID: 32043943 BACKGROUND

• Korupolu R, Stampas A, Uhlig-Reche H, Ciammaichella E, Mollett PJ, Achilike EC, Pedroza C. Comparing outcomes of mechanical ventilation with high vs. moderate tidal volumes in tracheostomized patients with spinal cord injury in acute inpatient rehabilitation setting: a retrospective cohort study. Spinal Cord. 2021 Jun;59(6):618-625. doi: 10.1038/s41393-020-0517-4. Epub 2020 Jul 9.

  PMID: 32647326 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Pneumonia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Radha Korupolu, MD
• Organization: The University of Texas Health Science Center at Houston

Radha.korupolu@uth.tmc.edu

713-797-5233

Study Officials

• Radha Korupolu, MD

  McGovern Medical School, The University of Texas Health Science Center at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, principal investigator, outcome assessors, and statistician will be blinded to tidal volume assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: June 3, 2021
• Study Start: December 17, 2021
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: July 15, 2025
• Results First Posted: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)