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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Sponsor: University of Göttingen

Current Primary Outcome: 28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications [ Time Frame: 30 days after enrollment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure [ Time Frame: 30 days after enrollment ]

Original Secondary Outcome: Same as current

Information By: University of Göttingen

Dates:
Date Received: April 20, 2009
Date Started: March 2005
Date Completion:
Last Updated: April 21, 2009
Last Verified: April 2009