Spinal Cord InjuriesNCT04912583
Comparison of Low and High Tidal Volumes in Acute Spinal Cord Injury
A study testing High tidal volume and Low tidal volume in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- High tidal volume and Low tidal volume
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Dec 2021to 27 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Craig Hospital
Englewood, Colorado, 80113
TIRR Memorial Hermann
Houston, Texas, 77030
About this study
Official title: Comparison of Mechanical Ventilation With Low and High Tidal Volumes in Acute Spinal Cord Injury: A Pilot Randomized Comparative Effectiveness Trial
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
Read more
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.
Read the detailed description
Background: Respiratory complications associated with mechanical ventilation (MV) are the leading cause of morbidity and mortality following acute spinal cord injury (SCI). Emerging evidence suggests pneumonia is also associated with reduced neurologic recovery. Therefore, pneumonia prevention is of primary importance to improve outcomes. In the non-SCI population, MV with lower tidal volume (Vt) has been shown to reduce inflammation and rates of pneumonia. High Vt MV results in disruption of pulmonary endothelium and release of inflammatory mediators, which play a role in the development of pulmonary complications. In contrast, guidelines for SCI practitioners recommend MV with higher Vt without strong evidence.
Objective: The primary objective of this study is to evaluate the feasibility of conducting a randomized control trial comparing MV with high vs. low Vt. Secondary objectives include a comparison of clinical outcomes and inflammatory mediators between these groups.
Methods: Study population: Adults with acute traumatic SCI admitted to an acute inpatient rehabilitation facility on 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. Study participants will be randomly assigned to high tidal volume (14-16 ml/kg pbw) or low tidal volume of 8 to 10 ml/kg pbw within 48 hrs of admission, stratified based on vital capacity at admission to ensure equal allocation of those with most severe respiratory impairment and unlikely to wean from the vent.
Importance of knowledge gained from the study: Investigators believe the completion of this study will add to the fund of knowledge of respiratory management of people with SCI, especially at the early stages of the injury, including reducing respiratory complications in people with SCI who are at very high risk of severe respiratory complications which is the main cause of morbidity and mortality in this population.
- Conditions
- Spinal Cord Injuries
- Being tested
- High tidal volume, Low tidal volume
- Keywords
- Spinal cord injury, Mechanical ventilation, Pneumonia, Tidal volume
- Medical subject headings
- Spinal Cord Injuries, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High tidal volumeDevice
A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
Low tidal volumeDevice
A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Low tidal volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the time of enrollment to time of discharge from hospital (about 6 weeks)
Secondary outcomes (4)
Feasibility as Assessed by Recruitment Rate
Recruitment rate is the proportion of eligible people who provide consent.
Measured: At the time of consent (within 48 hours of hospital admission)
Feasibility as Assessed by Adherence Rate
Adherence rate is the proportion of participants in each group who receive the assigned intervention per protocol.
Measured: At the time of start of intervention (within 48 hours of hospital admission)
Feasibility as Assessed by Retention Rate
Retention rate is the number of participants in each group who complete all study procedures.
Measured: at the time of discharge from hospital (about 6 weeks after admission)
Feasibility as Assessed by Number of Participants With Missing Data
Measured: From the time of enrollment to time of discharge from hospital (about 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start17 Dec 2021
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- TIRR Memorial Hermann, Craig Hospital, National Center for Advancing Translational Sciences (NCATS), The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Radha Korupolu, The University of Texas Health Science Center, Houston
- Investigators
- Radha Korupolu, MD, Principal investigator, McGovern Medical School, The University of Texas Health Science Center at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912583
- Sponsor's protocol ID
- HSC-MS-21-0222
- Other IDs
- KL2TR003168
- Status last verified
- Jun 2025
- First submitted
- 29 Apr 2021
- Last updated
- 15 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32043943Korupolu 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.
PubMed 32647326
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mechanical Ventilation With Low and High Tidal Volumes in Acute Spinal Cord Injury: A Pilot Randomized Comparative Effectiveness Trial
- ClinicalTrials.gov ID
- NCT04912583
- Acronym / sponsor ID
- HSC-MS-21-0222
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord injury, Mechanical ventilation, Pneumonia, Tidal volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- TIRR Memorial Hermann, Craig Hospital, National Center for Advancing Translational Sciences (NCATS), The Craig H. Neilsen Foundation
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Posted 15 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Respiratory complications associated with mechanical ventilation (MV) are the leading cause of morbidity and mortality following acute spinal cord injury (SCI). Emerging evidence suggests pneumonia is also associated with reduced neurologic recovery. Therefore, pneumonia prevention is of primary importance to improve outcomes. In the non-SCI population, MV with lower tidal volume (Vt) has been shown to reduce inflammation and rates of pneumonia. High Vt MV results in disruption of pulmonary endothelium and release of inflammatory mediators, which play a role in the development of pulmonary complications. In contrast, guidelines for SCI practitioners recommend MV with higher Vt without strong evidence.
Objective: The primary objective of this study is to evaluate the feasibility of conducting a randomized control trial comparing MV with high vs. low Vt. Secondary objectives include a comparison of clinical outcomes and inflammatory mediators between these groups.
Methods: Study population: Adults with acute traumatic SCI admitted to an acute inpatient rehabilitation facility on 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. Study participants will be randomly assigned to high tidal volume (14-16 ml/kg pbw) or low tidal volume of 8 to 10 ml/kg pbw within 48 hrs of admission, stratified based on vital capacity at admission to ensure equal allocation of those with most severe respiratory impairment and unlikely to wean from the vent.
Importance of knowledge gained from the study: Investigators believe the completion of this study will add to the fund of knowledge of respiratory management of people with SCI, especially at the early stages of the injury, including reducing respiratory complications in people with SCI who are at very high risk of severe respiratory complications which is the main cause of morbidity and mortality in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High tidal volume | Active comparator | Device: High tidal volumeA high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. |
| Low tidal volume | Active comparator | Device: Low tidal volumeA low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High tidal volumeA 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 volumeA low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation. | Device | Low tidal volume |
Primary outcome
Number of Episodes of Pneumonia
Time frame: 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.
4 secondary outcomes
Feasibility as Assessed by Recruitment Rate
Time frame: At the time of consent (within 48 hours of hospital admission)
Feasibility as Assessed by Adherence Rate
Time frame: At the time of start of intervention (within 48 hours of hospital admission)
Feasibility as Assessed by Retention Rate
Time frame: at the time of discharge from hospital (about 6 weeks after admission)
Feasibility as Assessed by Number of Participants With Missing Data
Time frame: From the time of enrollment to time of discharge from hospital (about 6 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32043943Hatton 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.
- Background: PubMed 32647326Korupolu 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.
- Individual participant dataSharing planned: No
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radha Korupolu, MD principal investigator
McGovern Medical School, The University of Texas Health Science Center at Houston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High tidal volume and Low tidal volume in people with Spinal Cord Injuries, run by The University of Texas Health Science Center, Houston at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Episodes of Pneumonia (time frame: From the time of enrollment to time of discharge from hospital (about 6 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04912583, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.