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

NCT00412308 | Completed

• 1 other identifier: H133N060005
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Respiratory Insufficiency

Keywords

spinal cord injury; ventilator dependency; ventilator weaning; tidal volume

Outcome Measures

Primary Outcomes (5)

• Time to full weaning from ventilator

• Episodes of atelectasis

• Episodes of ventilator-acquired pneumonia

• Episodes of barotrauma

• Episodes of acute respiratory distress syndrome

Interventions

Tidal volume used in mechanical ventilation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Respiratory Insufficiency

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2006
• First Posted: December 18, 2006
• Study Start: December 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2010
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

US (1)