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A Comparison of High vs. Low Tidal Volumes in Ventilator Weaning for Individuals With Cervical Spinal Cord Injuries

This study has been completed.
Sponsor:
Information provided by:
Craig Hospital
ClinicalTrials.gov Identifier:
NCT00412308
First received: December 14, 2006
Last updated: June 27, 2011
Last verified: June 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Central Nervous System Diseases
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014