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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00557752

Enrollment

Registered

2007-11-14

Start date

2005-09-30

Completion date

2008-06-30

Last updated

2009-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Respiratory Failure

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.

Interventions

DEVICENon-invasive ventilation

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Intubation rate	1 month

Secondary

Measure	Time frame
Pneumothorax rate	1 month
Pneumonia rate	1 month
Intensive Care Unit stay	2 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026