High tidal volume for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Spinal Cord InjuryLow tidal volume - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Spinal Cord Injury

Treatment Effectiveness

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: At the time of consent (within 48 hours of hospital admission)

Hour 48
Feasibility as assessed by recruitment rate
Hour 48
Feasibility as assessed by adherence rate
Week 6
Number of respiratory complications
Week 6
Number of episodes of pneumonia
Week 6
Feasibility as assessed by retention rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

High tidal volume
1 of 2
Low tidal volume
1 of 2

Active Control

30 Total Participants · 2 Treatment Groups

Primary Treatment: High tidal volume · No Placebo Group · Phase 2

High tidal volume
Device
ActiveComparator Group · 1 Intervention: High tidal volume · Intervention Types: Device
Low tidal volume
Device
ActiveComparator Group · 1 Intervention: Low tidal volume · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at the time of consent (within 48 hours of hospital admission)

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
171 Previous Clinical Trials
124,664 Total Patients Enrolled
TIRR Memorial HermannOTHER
15 Previous Clinical Trials
4,720 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
812 Previous Clinical Trials
256,229 Total Patients Enrolled
Radha KorupoluPrincipal InvestigatorMcGovern Medical School, The University of Texas Health Science Center at Houston
1 Previous Clinical Trials
8 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Adults who are at least 18 years old have different lung volumes and ventilator settings than those who are younger than 18 years old.
The individual required mechanical ventilation at the time of admission to TIRR.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
TIRR Memorial Hermann100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%