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Efficacy of Non-Invasive Mechanical Ventilation in Early Hypoxia Secondary to Thoracic Trauma

This study has been terminated.
(Review Board stopped the study after interim analysis reaching stopping rule for efficacy.)
Sponsor:
Collaborator:
Mutua Madrileña Automovilista Medical Investigation Foundation
Information provided by:
Hospital Virgen de la Salud
ClinicalTrials.gov Identifier:
NCT00557752
First received: November 13, 2007
Last updated: February 6, 2009
Last verified: February 2009
History of Changes
  Purpose
  • Severe post-traumatic hypoxia is mainly due to lung contusion. The intubation rate of these patients is near 20%.
  • Treatment before intubation is needed, is based on pain control with epidural anesthesia and oxygen.
  • The investigators' hypothesis is that adding non-invasive mechanical ventilation to the standard treatment can reduce the intubation rate if applied early in the course of the disease.
  • As thoracic trauma is often associated with injuries in other body regions that may increase the complications of the technique, specific contraindications have been described.

Condition Intervention Phase
Post-Traumatic Respiratory Failure
 Device: Non-invasive ventilation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Virgen de la Salud:

Primary Outcome Measures:
  • Intubation rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pneumothorax rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • Pneumonia rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Intensive Care Unit stay [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: September 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Addition to the standard therapy of non-invasive mechanical ventilation. Continuously for the first 24 hours, then trials to discontinuation every 24 hours. Interface adjusted for the associated injuries.
 Device: Non-invasive ventilation
Applied continuously for the first 24 hours, then every 24 hours, trial of discontinuation. Interface specific for the associated injuries.
No Intervention: 2
Standard therapy for severe post-traumatic hypoxia: pain control with epidural anesthesia and oxygen.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years.
  • Informed consent obtained.
  • pO2/FiO2 <200 for more than 8 consecutive hours in the first 48 hours after thoracic trauma.

Exclusion Criteria:

  • Orotracheal intubation indicated for any other reason.
  • Standard contraindication for non-invasive ventilation (active gastro-intestinal haemorrhage, low level of consciousness, multiorgan failure, airway control problems, lack of cooperation, hemodynamic instability).
  • Severe traumatic brain injury.
  • Facial trauma with pneumocephalus, skull base fracture, orbit base fracture, any facial fracture involving a sinus.
  • Cervical injury with specific treatment contraindicating a facial mask.
  • Bronco-pleural fistula.
  • Gastro-intestinal trauma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00557752

Locations
Spain
Hospital 12 de Octubre
Madrid, Spain, 28045
Hospital Virgen de la Salud
Toledo, Spain, 45004
Sponsors and Collaborators
Hospital Virgen de la Salud
Mutua Madrileña Automovilista Medical Investigation Foundation
Investigators
Principal Investigator: Gonzalo Hernandez, Dr. Hospital Virgen de la Salud
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ramon Galvez Zaloña, SESCAM
ClinicalTrials.gov Identifier: NCT00557752     History of Changes
Other Study ID Numbers: 06001-00
Study First Received: November 13, 2007
Last Updated: February 6, 2009
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Anoxia
Respiratory Insufficiency
Signs and Symptoms, Respiratory
 Signs and Symptoms
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013