Out-of-Hospital Non-Invasive Ventilation in Patients With Acute Respiratory Insufficiency
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Respiratory Insufficiency
- Sponsor
- University of Göttingen
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- 28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications
- Status
- Completed
- Last Updated
- 17 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications
Time Frame: 30 days after enrollment
Secondary Outcomes
- out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure(30 days after enrollment)