Out-of-Hospital Non-Invasive Ventilation for Patients With Acute Respiratory Failure (NIV)
|Respiratory Insufficiency Respiratory Failure||Procedure: Non-invasive-ventilation Procedure: conventional treatment|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Out-of-Hospital Non-Invasive Ventilation in Patients With Acute Respiratory Insufficiency|
- 28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications [ Time Frame: 30 days after enrollment ]
- out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure [ Time Frame: 30 days after enrollment ]
|Study Start Date:||March 2005|
|Study Completion Date:||April 2009|
|Primary Completion Date:||January 2007 (Final data collection date for primary outcome measure)|
Active Comparator: 1
increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation
Active Comparator: 2
Procedure: conventional treatment
oxygen, diuretics, bronchodilators, positive inotropic drugs
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885898
|Goettingen, Lower Saxony, Germany, 37073|
|Study Director:||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|