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

Primary Purpose

Post-Traumatic Respiratory Failure

Status

Terminated

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Non-invasive ventilation

About this trial

This is an interventional prevention trial for Post-Traumatic Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Hospital 12 de Octubre
Hospital Virgen de la Salud

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Intubation rate

Secondary Outcome Measures

Pneumothorax rate

Pneumonia rate

Intensive Care Unit stay

Full Information

NCT ID

NCT00557752

First Posted

November 13, 2007

Last Updated

February 6, 2009

Sponsor

Hospital Virgen de la Salud

Collaborators

Fundación Mutua Madrileña

1. Study Identification

Unique Protocol Identification Number

NCT00557752

Brief Title

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

Official Title

Non-Invasive Ventilation in Early Severe Posttraumatic Hypoxia: a Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Terminated

Why Stopped

Review Board stopped the study after interim analysis reaching stopping rule for efficacy.

Study Start Date

September 2005 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hospital Virgen de la Salud

Collaborators

Fundación Mutua Madrileña

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Respiratory Failure

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Arm Title

Arm Type

No Intervention

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Non-invasive ventilation

Intervention Description

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

Primary Outcome Measure Information:

Title

Intubation rate

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Pneumothorax rate

Time Frame

1 month

Title

Pneumonia rate

Time Frame

1 month

Title

Intensive Care Unit stay

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gonzalo Hernandez, Dr.

Organizational Affiliation

Hospital Virgen de la Salud

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital 12 de Octubre

City

Madrid

ZIP/Postal Code

28045

Country

Spain

Facility Name

Hospital Virgen de la Salud

City

Toledo

ZIP/Postal Code

45004

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

11867822

Citation

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.

Results Reference

result

PubMed Identifier

19749006

Citation

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.

Results Reference

derived

Learn more about this trial

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

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