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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

Brief Summary:
  • 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 or disease Intervention/treatment Phase
Post-Traumatic Respiratory Failure Device: Non-invasive ventilation Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial
Study Start Date : September 2005
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Intubation rate [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Pneumothorax rate [ Time Frame: 1 month ]
  2. Pneumonia rate [ Time Frame: 1 month ]
  3. Intensive Care Unit stay [ Time Frame: 2 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00557752

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Hospital 12 de Octubre
Madrid, Spain, 28045
Hospital Virgen de la Salud
Toledo, Spain, 45004
Sponsors and Collaborators
Hospital Virgen de la Salud
Fundación Mutua Madrileña
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Principal Investigator: Gonzalo Hernandez, Dr. Hospital Virgen de la Salud
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ramon Galvez Zaloña, SESCAM Identifier: NCT00557752    
Other Study ID Numbers: 06001-00
First Posted: November 14, 2007    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: February 2009
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory