Out-of-Hospital Non-Invasive Ventilation for Patients With Acute Respiratory Failure

Study Overview
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Brief Summary
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In the past, patients suffering from acute respiratory failure had to be treated with Oxygen and specific medication, or - if this had not been sufficient - had to be anesthesized and had to undergo endotracheal intubation for invasive ventilation. Nowadays, since emergency ventilators are available that can be used for non-invasive ventilation, the purpose of this study is to investigate if non-invasive ventilation is safe, feasible and effective for the treatment of acute respiratory failure and if less patients will need to be intubated out-of-hospital as well as in the further course.

Detailed Description
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Single center, prospective, randomized, intention-to-treat clinical trial. The study has been performed within a two tier EMS system of a major city. Prehospital emergency physicians are on scene in every patient enrolled to the study. Patients with acute respiratory failure (SaO2 < 90%, respiratory rate > 20/min) were enrolled to the study using envelopes for randomisation for either conventional (O2 + medication) or NIV. Vital signs have been documented as well as venous blood gases have been taken every 10 minutes after treatment has been started. Primary endpoints are 28-day mortality, hospital-, ICU- and respirator-days, SAPS, SOFA II and complications. Secondary endpoints are out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure.

Official Title
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Out-of-Hospital Non-Invasive Ventilation in Patients With Acute Respiratory Insufficiency

Conditions
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Respiratory Insufficiency, Respiratory Failure

Intervention / Treatment
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* Procedure: Non-invasive-ventilation
* Procedure: conventional treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute respiratory failure at least 18 years old cooperative Exclusion Criteria: cardiac arrest respiratory arrest unconscious uncontrollable agitation less than 18 years old

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Non-invasive ventilation | Procedure: Non-invasive-ventilation<br>* increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation<br>|
| Active Comparator: 2<br>Conventional | Procedure: conventional treatment<br>* oxygen, diuretics, bronchodilators, positive inotropic drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications |  | 30 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure |  | 30 days after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Respiratory Insufficiency, Respiratory Failure