Respiratory Failure, Respiratory Insufficiency
Conditions
Keywords
Respiratory Insufficiency, Respiratory Failure
Brief summary
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
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.
Interventions
increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation
oxygen, diuretics, bronchodilators, positive inotropic drugs
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications | 30 days after enrollment |
Secondary
| Measure | Time frame |
|---|---|
| out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure | 30 days after enrollment |
Countries
Germany