Clinical trial NCT00885898: Out-of-Hospital Non-Invasive Ventilation for Patients With Acute Respiratory Failure
Official title: Out-of-Hospital Non-Invasive Ventilation in Patients With Acute Respiratory Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Insufficiency
Respiratory Failure
Keywords: Respiratory Insufficiency
Respiratory Failure
Lead sponsor: University of Göttingen
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications
timeFrame: 30 days after enrollment
Secondary outcomes:
measure: out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure
timeFrame: 30 days after enrollment
Other outcomes:
Locations:
city: Goettingen
country: Germany
facility: EMS
state: Lower Saxony
Study officials:
affiliation: Department of Anesthesiology, Emergency- and Intensive Care Medicine, Georg-August-University Goettingen, Germany
name: Markus S Roessler, Dr. med., M.D., D.E.A.A., EDIC
role: STUDY_DIRECTOR
References:
citation: 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.