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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:
ClinicalTrials.gov Identifier:
NCT00557752
First Posted: November 14, 2007
Last Update Posted: February 9, 2009
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.
Collaborator:
Fundación Mutua Madrileña
Information provided by:
Hospital Virgen de la Salud
  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
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

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

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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
Fundación Mutua Madrileña
Investigators
Principal Investigator: Gonzalo Hernandez, Dr. Hospital Virgen de la Salud
  More Information

Publications:
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
First Submitted: November 13, 2007
First Posted: November 14, 2007
Last Update Posted: February 9, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases