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| Sponsor: | Craig Hospital |
|---|---|
| Information provided by: | Craig Hospital |
| ClinicalTrials.gov Identifier: | NCT00412308 |
Purpose
The study will compare outcomes between individuals with sub-acute, ventilator-dependent tetraplegia using high (20 cc/kg) vs. low (10 cc/kg) tidal volumes during mechanical ventilator support.
| Condition | Intervention |
|---|---|
|
Spinal Cord Injury Respiratory Insufficiency |
Procedure: Tidal volume used in mechanical ventilation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Comparison of High vs. Low Tidal Volumes in Ventilator Weaning for Individuals With Sub-Acute Cervical Spinal Cord Injuries |
| Enrollment: | 34 |
| Study Start Date: | December 2006 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Colorado | |
| Craig Hospital | |
| Englewood, Colorado, United States, 80113 | |
| Principal Investigator: | Mary Warner, MD | South Denver Pulmonary Associates PC |
| Principal Investigator: | James Fenton, MD | South Denver Pulmonary Associates, PC |
| Principal Investigator: | Daniel P Lammertse, MD | Craig Hospital |
More Information
| Responsible Party: | Daniel Lammertse, MD, Craig Hospital |
| ClinicalTrials.gov Identifier: | NCT00412308 History of Changes |
| Other Study ID Numbers: | H133N060005 |
| Study First Received: | December 14, 2006 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
spinal cord injury ventilator dependency ventilator weaning tidal volume |
|
Respiratory Insufficiency Spinal Cord Injuries Respiration Disorders Respiratory Tract Diseases Spinal Cord Diseases |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Wounds and Injuries |