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

NCT ID: NCT00885898

Last Updated: 2009-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2009-04-30

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.

Conditions

Respiratory Insufficiency; Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

"Non-invasive ventilation"

Group Type: ACTIVE_COMPARATOR

Non-invasive-ventilation

Intervention Type: PROCEDURE

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

2

"Conventional"

Group Type: ACTIVE_COMPARATOR

conventional treatment

Intervention Type: PROCEDURE

oxygen, diuretics, bronchodilators, positive inotropic drugs

Interventions

Non-invasive-ventilation

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

Intervention Type: PROCEDURE

conventional treatment

oxygen, diuretics, bronchodilators, positive inotropic drugs

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Göttingen

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Anesthesiology, Emergency- & Int. Care Med., Univ. Med. Goettingen, Germany

Principal Investigators

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

Role: STUDY_DIRECTOR

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

Locations

EMS

Göttingen, Lower Saxony, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 18409119 (View on PubMed)

Other Identifiers

40/11/04 UGoettingen

Identifier Type: -

Identifier Source: org_study_id