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Mechanical Ventilation

Ventilation Strategies for Spinal Cord Injury

N/A
Recruiting
Led By Radha Korupolu
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of consent (within 48 hours of hospital admission)
Awards & highlights

Study Summary

This trial is designed to study whether mechanical ventilation with a lower or higher tidal volume is more effective in people with acute spinal cord injury.

Who is the study for?
This trial is for adults over 18 with acute spinal cord injury (SCI) who are on mechanical ventilation. Eligible participants must have had their SCI for less than four months and be admitted to an acute inpatient rehab facility on a ventilator. Those with severe swallowing issues, significant brain injuries, pre-existing severe lung diseases, or those on prolonged antibiotics are excluded.Check my eligibility
What is being tested?
The study compares the effects of using high tidal volume (14-16 ml/kg body weight) versus low tidal volume (8-10 ml/kg body weight) during mechanical ventilation in patients with acute SCI. It aims to determine which method is more effective and feasible while monitoring inflammation markers.See study design
What are the potential side effects?
Risks associated with both high and low tidal volumes are similar to standard care practices; however, lower tidal volumes may reduce the risk of pneumonia and other respiratory complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a spinal cord injury at C1-C5 and need a ventilator.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the time of start of intervention (within 48 hours of hospital admission)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the time of start of intervention (within 48 hours of hospital admission) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of episodes of pneumonia
Secondary outcome measures
Feasibility as assessed by adherence rate
Feasibility as assessed by recruitment rate
Feasibility as assessed by retention rate
Other outcome measures
Number of respiratory complications

Trial Design

2Treatment groups
Active Control
Group I: High tidal volumeActive Control1 Intervention
A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
Group II: Low tidal volumeActive Control1 Intervention
A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.

Find a Location

Who is running the clinical trial?

Craig H. Neilsen Foundation (CNHF)UNKNOWN
The University of Texas Health Science Center, HoustonLead Sponsor
902 Previous Clinical Trials
320,874 Total Patients Enrolled
TIRR Memorial HermannOTHER
15 Previous Clinical Trials
4,725 Total Patients Enrolled

Media Library

High Tidal Volume (Mechanical Ventilation) Clinical Trial Eligibility Overview. Trial Name: NCT04912583 — N/A
Spinal Cord Injury Research Study Groups: High tidal volume, Low tidal volume
Spinal Cord Injury Clinical Trial 2023: High Tidal Volume Highlights & Side Effects. Trial Name: NCT04912583 — N/A
High Tidal Volume (Mechanical Ventilation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04912583 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for the current participants of this experiment?

"Clinicaltrials.gov attests that this medical experiment is still open to enrollees, with the initial post dated December 17th 2021 and a recent update made on February 21st 2022."

Answered by AI

What is the aggregate number of participants currently enrolled in this experiment?

"Affirmative. The digital records stored on clinicaltrials.gov suggest that this medical trial is actively seeking individuals to enrol in the study, which was first posted on December 17th 2021 and most recently updated on February 21st 2022. Presently, 30 patient are required from a single site."

Answered by AI

Is Low tidal volume compliant with government regulatory standards?

"Low tidal volume has been rated a 2 on our safety scale, as this study is in its Phase 2 period. As such, there are some clinical data that attest to the treatment's safety but none which vouch for efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
TIRR Memorial Hermann
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~3 spots leftby Jun 2024