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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00412308
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : June 28, 2011
Information provided by:
Craig Hospital

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Respiratory Insufficiency Procedure: Tidal volume used in mechanical ventilation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Time to full weaning from ventilator
  2. Episodes of atelectasis
  3. Episodes of ventilator-acquired pneumonia
  4. Episodes of barotrauma
  5. Episodes of acute respiratory distress syndrome

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00412308

United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80113
Sponsors and Collaborators
Craig Hospital
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

Additional Information:
Responsible Party: Daniel Lammertse, MD, Craig Hospital Identifier: NCT00412308     History of Changes
Other Study ID Numbers: H133N060005
First Posted: December 18, 2006    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011

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

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases