Back to results

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

Primary Purpose

Respiratory Insufficiency, Respiratory Failure

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Non-invasive-ventilation

conventional treatment

About this trial

This is an interventional treatment trial for Respiratory Insufficiency focused on measuring Respiratory Insufficiency, Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

"Non-invasive ventilation"

"Conventional"

Outcomes

Primary Outcome Measures

28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications

Secondary Outcome Measures

out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure

Full Information

NCT ID

NCT00885898

First Posted

April 20, 2009

Last Updated

April 21, 2009

Sponsor

University of Göttingen

1. Study Identification

Unique Protocol Identification Number

NCT00885898

Brief Title

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

Acronym

NIV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Göttingen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Insufficiency, Respiratory Failure

Keywords

Respiratory Insufficiency, Respiratory Failure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

"Non-invasive ventilation"

Arm Title

Arm Type

Active Comparator

Arm Description

"Conventional"

Intervention Type

Procedure

Intervention Name(s)

Non-invasive-ventilation

Intervention Description

increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation

Intervention Type

Procedure

Intervention Name(s)

conventional treatment

Intervention Description

oxygen, diuretics, bronchodilators, positive inotropic drugs

Primary Outcome Measure Information:

Title

28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications

Time Frame

30 days after enrollment

Secondary Outcome Measure Information:

Title

out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure

Time Frame

30 days after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markus S Roessler, Dr. med., M.D., D.E.A.A., EDIC

Organizational Affiliation

Department of Anesthesiology, Emergency- and Intensive Care Medicine, Georg-August-University Goettingen, Germany

Official's Role

Study Director

Facility Information:

Facility Name

EMS

City

Goettingen

State/Province

Lower Saxony

ZIP/Postal Code

37073

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

18409119

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.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs