A Comparison of High vs. Low Tidal Volumes in Ventilator Weaning for Individuals With Cervical Spinal Cord Injuries
This study has been completed.
Sponsor:
Craig Hospital
Information provided by:
Craig Hospital
ClinicalTrials.gov Identifier:
NCT00412308
First received: December 14, 2006
Last updated: June 27, 2011
Last verified: June 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Resource links provided by NLM:
Further study details as provided by Craig Hospital:
Primary Outcome Measures:
- Time to full weaning from ventilator
- Episodes of atelectasis
- Episodes of ventilator-acquired pneumonia
- Episodes of barotrauma
- Episodes of acute respiratory distress syndrome
| 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 |
Criteria
Inclusion Criteria:
- Traumatic SCI at levels C3 through C6, ASIA A, B, or C tetraplegia
- Subacute admission to Craig Hospital between 2 weeks and 6 months post-injury
- Completely ventilator-dependent (24 hours a day) at the time of admission to Craig Hospital
- Age 18-55 years
- Informed consent obtained
Exclusion Criteria:
- Concurrent severe traumatic brain injury resulting in inability to cooperate with wean protocol
- Residual severe chest trauma (pneumothorax, recurrent pleural effusion > one third hemithorax, indwelling chest tubes, flail chest, trapped lung, bilateral pulmonary contusions)
- Residual esophageal trauma that may cause ongoing aspiration;
- Current ARDS
- Current VAP unresponsive to antibiotic therapy
- Premorbid cardiomyopathy with ejection fraction <30%, unstable angina, bullous emphysema, obstructive lung disease with forced expiratory volume < 50% predicted, morbid obesity with BMI ≥ 35, increased intracranial pressure, neuromuscular disease, chronic liver disease Child-Pugh Class C, or history of bone marrow or solid organ transplantation
- Critical illness polyneuropathy
- Burns over more than 30 percent of their body-surface area
- Current participation in another clinical trial
- Any condition that, in the judgment of the investigator, precludes successful participation in the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412308
Locations
| United States, Colorado | |
| Craig Hospital | |
| Englewood, Colorado, United States, 80113 | |
Sponsors and Collaborators
Craig Hospital
Investigators
| 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
Additional Information:
Related Info 
No publications provided
| 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 |
Keywords provided by Craig Hospital:
|
spinal cord injury ventilator dependency ventilator weaning tidal volume |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on May 22, 2013