Ventilation Strategies for Spinal Cord Injury

N/A

Waitlist Available

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

Must not have

Prolonged antibiotics for > 3 weeks at the time of admission due to infection

Severe dysphagia due to concomitant brain stem injury, which increases the risk of pneumonia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the time of consent (within 48 hours of hospital admission)

Awards & highlights

No Placebo-Only Group

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.

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.

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

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I have a spinal cord injury at C1-C5 and need a ventilator.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been on antibiotics for more than 3 weeks due to an infection.

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I have severe swallowing difficulties due to a brain injury.

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I have a severe brain injury that affects my ability to swallow and follow instructions.

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I have severe lung disease or ARDS upon hospital admission.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the time of start of intervention (within 48 hours of hospital admission)

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.