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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2008-06-30

Brief Summary

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* 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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Detailed Description

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Conditions

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Post-Traumatic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Non-invasive ventilation

Intervention Type DEVICE

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

2

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Non-invasive ventilation

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No