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

April 20, 2009
April 21, 2009
March 2005
January 2007   (final data collection date for primary outcome measure)
28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications [ Time Frame: 30 days after enrollment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00885898 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Out-of-Hospital Non-Invasive Ventilation for Patients With Acute Respiratory Failure
Out-of-Hospital Non-Invasive Ventilation in Patients With Acute Respiratory Insufficiency

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Respiratory Insufficiency
  • Respiratory Failure
  • 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
  • Active Comparator: 1
    "Non-invasive ventilation"
    Intervention: Procedure: Non-invasive-ventilation
  • Active Comparator: 2
    "Conventional"
    Intervention: Procedure: conventional treatment
Roessler M. [Non-invasive ventilation in prehospital emergency medicine] Anasthesiol Intensivmed Notfallmed Schmerzther. 2008 Apr;43(4):264-6. German.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
April 2009
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00885898
40/11/04 UGoettingen
No
Dr. med. Markus Roessler, M.D., D.E.A.A., EDIC, Dept. of Anesthesiology, Emergency- & Int. Care Med., Univ. Med. Goettingen, Germany
University of Göttingen
Not Provided
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
University of Göttingen
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP