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Sponsored by: |
Craig Hospital |
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Information provided by: | Craig Hospital |
ClinicalTrials.gov Identifier: | NCT00412308 |
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 |
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Spinal Cord Injury Respiratory Insufficiency |
Procedure: Tidal volume used in mechanical ventilation |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Comparison of High vs. Low Tidal Volumes in Ventilator Weaning for Individuals With Sub-Acute Cervical Spinal Cord Injuries |
Estimated Enrollment: | 70 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | December 2010 |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Susan Charlifue, PhD | 303 789 8306 | susie@craighospital.org |
Contact: Amit Jha, MD | 303 789 8564 | ajha@xcraighospital.org |
United States, Colorado | |
Craig Hospital | Recruiting |
Englewood, Colorado, United States, 80113 | |
Contact: Susan Charlifue, PhD 303-789-8306 susie@craighospital.org | |
Contact: Amit Jha, MD 303 789 8564 ajha@craighospital.org | |
Principal Investigator: Daniel P Lammertse, MD | |
Sub-Investigator: Amit Jha, MD | |
Sub-Investigator: Susan Charlifue, PhD | |
Sub-Investigator: Gale Whiteneck, PhD | |
Sub-Investigator: Lonnie Martinez, RRT |
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 |
Study ID Numbers: | H133N060005 |
Study First Received: | December 14, 2006 |
Last Updated: | December 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00412308 |
Health Authority: | United States: Institutional Review Board |
spinal cord injury ventilator dependency ventilator weaning tidal volume |
Spinal Cord Injuries Respiratory Insufficiency Spinal Cord Diseases Respiratory Tract Diseases Respiration Disorders |
Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases Trauma, Nervous System |
Nervous System Diseases |