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

NCT00557752 | Terminated Phase 4 DMC

• 1 other identifier: 06001-00
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-Traumatic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Intubation rate

  1 month

Secondary Outcomes (3)

• Pneumothorax rate

  1 month

• Pneumonia rate

  1 month

• Intensive Care Unit stay

  2 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

NO INTERVENTION

Standard therapy for severe post-traumatic hypoxia: pain control with epidural anesthesia and oxygen.

Interventions

Non-invasive ventilation DEVICE

Applied continuously for the first 24 hours, then every 24 hours, trial of discontinuation. Interface specific for the associated injuries.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Virgen de la Salud: lead
• Fundación Mutua Madrileña: collaborator

Study Sites (2)

Hospital 12 de Octubre

Madrid, Madrid, 28045, Spain

Location

Hospital Virgen de la Salud

Toledo, Toledo, 45004, Spain

Location

Related Publications (2)

• British Thoracic Society Standards of Care Committee. Non-invasive ventilation in acute respiratory failure. Thorax. 2002 Mar;57(3):192-211. doi: 10.1136/thorax.57.3.192. No abstract available.

  PMID: 11867822 RESULT

• Hernandez G, Fernandez R, Lopez-Reina P, Cuena R, Pedrosa A, Ortiz R, Hiradier P. Noninvasive ventilation reduces intubation in chest trauma-related hypoxemia: a randomized clinical trial. Chest. 2010 Jan;137(1):74-80. doi: 10.1378/chest.09-1114. Epub 2009 Sep 11.

  PMID: 19749006 DERIVED

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Gonzalo Hernandez, Dr.

  Hospital Virgen de la Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2007
• First Posted: November 14, 2007
• Study Start: September 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 9, 2009

Record last verified: 2009-02

Locations

ES (2)