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

Respiratory Failure Clinical Trial

— NIV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885898
• Other study ID #: 40/11/04 UGoettingen
• Status: Completed
• Phase: N/A
• First received: April 20, 2009
• Last updated: April 21, 2009
• Start date: March 2005
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: University of Göttingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2009
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Procedure:
• Non-invasive-ventilation
increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation
• conventional treatment
oxygen, diuretics, bronchodilators, positive inotropic drugs

Locations

Country	Name	City	State
Germany	EMS	Goettingen	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
University of Göttingen

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications		30 days after enrollment	Yes
Secondary	out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure		30 days after enrollment	Yes