NCT00885898

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of Göttingen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Insufficiency
• Respiratory Failure

Interventions

Type	Name	Description
PROCEDURE	Non-invasive-ventilation	increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation
PROCEDURE	conventional treatment	oxygen, diuretics, bronchodilators, positive inotropic drugs

Timeline

• Start date: 2005-03-01
• Primary completion: 2007-01-01
• Completion: 2009-04-01
• First posted: 2009-04-22
• Last updated: 2009-04-22

Locations

1 site across 1 country: Germany