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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:
Fundación Mutua Madrileña
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

November 13, 2007
February 6, 2009
September 2005
June 2008   (final data collection date for primary outcome measure)
Intubation rate [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Intubation rate [ Time Frame: Hospital stay ]
Complete list of historical versions of study NCT00557752 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00557752
06001-00
Yes
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