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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | "Non-invasive ventilation" |
|
| 2 | Active Comparator | "Conventional" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive-ventilation | Procedure | increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications | 30 days after enrollment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus S Roessler, Dr. med., M.D., D.E.A.A., EDIC | Department of Anesthesiology, Emergency- and Intensive Care Medicine, Georg-August-University Goettingen, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EMS | Göttingen | Lower Saxony | 37073 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18409119 | Background | Roessler M. [Non-invasive ventilation in prehospital emergency medicine]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2008 Apr;43(4):264-6. doi: 10.1055/s-2008-1076608. German. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D063087 | Noninvasive Ventilation |
| ID | Term |
|---|---|
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| conventional treatment | Procedure | oxygen, diuretics, bronchodilators, positive inotropic drugs |
|