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

This study has been completed.
Sponsor:
Information provided by:
University of Göttingen
ClinicalTrials.gov Identifier:
NCT00885898
First received: April 20, 2009
Last updated: April 21, 2009
Last verified: April 2009
History of Changes
  Purpose

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.


Condition Intervention
Respiratory Insufficiency
Respiratory Failure
 Procedure: Non-invasive-ventilation
Procedure: conventional treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Out-of-Hospital Non-Invasive Ventilation in Patients With Acute Respiratory Insufficiency

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Göttingen:

Primary Outcome Measures:
  • 28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications [ Time Frame: 30 days after enrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure [ Time Frame: 30 days after enrollment ] [ Designated as safety issue: Yes ]

Enrollment: 51
Study Start Date: March 2005
Study Completion Date: April 2009
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
"Non-invasive ventilation"
 Procedure: Non-invasive-ventilation
increased oxygen fraction, continuous positive pressure ventilation, if necessary pressure support ventilation or even intermittent positive pressure ventilation
Active Comparator: 2
"Conventional"
 Procedure: conventional treatment
oxygen, diuretics, bronchodilators, positive inotropic drugs

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885898

Locations
Germany
EMS
Goettingen, Lower Saxony, Germany, 37073
Sponsors and Collaborators
University of Göttingen
Investigators
Study Director: Markus S Roessler, Dr. med., M.D., D.E.A.A., EDIC Department of Anesthesiology, Emergency- and Intensive Care Medicine, Georg-August-University Goettingen, Germany
  More Information

Publications:

Responsible Party: Dr. med. Markus Roessler, M.D., D.E.A.A., EDIC, Dept. of Anesthesiology, Emergency- & Int. Care Med., Univ. Med. Goettingen, Germany
ClinicalTrials.gov Identifier: NCT00885898     History of Changes
Other Study ID Numbers: 40/11/04 UGoettingen
Study First Received: April 20, 2009
Last Updated: April 21, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by University of Göttingen:
Respiratory Insufficiency
Respiratory Failure

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013