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

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: NCT00557752
Recruitment Status : Terminated (Review Board stopped the study after interim analysis reaching stopping rule for efficacy.)
First Posted : November 14, 2007
Last Update Posted : February 9, 2009
Fundación Mutua Madrileña
Information provided by:
Hospital Virgen de la Salud

November 13, 2007
November 14, 2007
February 9, 2009
September 2005
June 2008   (Final data collection date for primary outcome measure)
Intubation rate [ Time Frame: 1 month ]
Intubation rate [ Time Frame: Hospital stay ]
Complete list of historical versions of study NCT00557752 on Archive Site
  • Pneumothorax rate [ Time Frame: 1 month ]
  • Pneumonia rate [ Time Frame: 1 month ]
  • Intensive Care Unit stay [ Time Frame: 2 months ]
  • Pneumothorax rate [ Time Frame: Intensive Care Unit stay ]
  • Pneumonia rate [ Time Frame: Intensive Care Unit stay ]
  • Intensive Care Unit stay [ Time Frame: Intensive Care Unit stay ]
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Efficacy of Non-Invasive Mechanical Ventilation in Early Hypoxia Secondary to Thoracic Trauma
Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial
  • 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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Post-Traumatic Respiratory Failure
Device: Non-invasive ventilation
Applied continuously for the first 24 hours, then every 24 hours, trial of discontinuation. Interface specific for the associated injuries.
  • 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.
    Intervention: Device: Non-invasive ventilation
  • No Intervention: 2
    Standard therapy for severe post-traumatic hypoxia: pain control with epidural anesthesia and oxygen.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2008
June 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Ramon Galvez Zaloña, SESCAM
Hospital Virgen de la Salud
Fundación Mutua Madrileña
Principal Investigator: Gonzalo Hernandez, Dr. Hospital Virgen de la Salud
Hospital Virgen de la Salud
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP