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A Comparison of High vs. Low Tidal Volumes in Ventilator Weaning for Individuals With Cervical Spinal Cord Injuries
This study is currently recruiting participants.
Verified by Craig Hospital, December 2006
First Received: December 14, 2006   No Changes Posted
Sponsored by: 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

MedlinePlus related topics: Spinal Cord Injuries
U.S. FDA Resources
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

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

Estimated Enrollment: 70
Study Start Date: December 2006
Estimated Study Completion Date: December 2010
  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

Contacts
Contact: Susan Charlifue, PhD 303 789 8306 susie@craighospital.org
Contact: Amit Jha, MD 303 789 8564 ajha@xcraighospital.org

Locations
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            
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:
No publications provided

Study ID Numbers: H133N060005
Study First Received: December 14, 2006
Last Updated: December 14, 2006
ClinicalTrials.gov Identifier: NCT00412308     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Craig Hospital:
spinal cord injury
ventilator dependency
ventilator weaning
tidal volume

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Spinal Cord Injuries
Respiratory Insufficiency
Spinal Cord Diseases
Respiratory Tract Diseases
Nervous System Diseases
Respiration Disorders
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on May 07, 2009