Status:
COMPLETED
A Comparison of High vs. Low Tidal Volumes in Ventilator Weaning for Individuals With Cervical Spinal Cord Injuries
Lead Sponsor:
Craig Hospital
Conditions:
Spinal Cord Injury
Respiratory Insufficiency
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
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.
Detailed Description
While respiratory failure in people with SCI is common, clinicians have not come to a consensus on the best strategy to manage the mechanical ventilation of these individuals or whether to manage peop...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00412308
Start Date
December 1 2006
End Date
August 1 2010
Last Update
June 28 2011
Active Locations (1)
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1
Craig Hospital
Englewood, Colorado, United States, 80113