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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014