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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00885898
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : April 22, 2009
Information provided by:
University of Göttingen

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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Respiratory Failure Procedure: Non-invasive-ventilation Procedure: conventional treatment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Out-of-Hospital Non-Invasive Ventilation in Patients With Acute Respiratory Insufficiency
Study Start Date : March 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Procedure: conventional treatment
oxygen, diuretics, bronchodilators, positive inotropic drugs

Primary Outcome Measures :
  1. 28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications [ Time Frame: 30 days after enrollment ]

Secondary Outcome Measures :
  1. out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure [ Time Frame: 30 days after enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00885898

Goettingen, Lower Saxony, Germany, 37073
Sponsors and Collaborators
University of Göttingen
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

Responsible Party: Dr. med. Markus Roessler, M.D., D.E.A.A., EDIC, Dept. of Anesthesiology, Emergency- & Int. Care Med., Univ. Med. Goettingen, Germany Identifier: NCT00885898     History of Changes
Other Study ID Numbers: 40/11/04 UGoettingen
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: April 22, 2009
Last Verified: April 2009

Keywords provided by University of Göttingen:
Respiratory Insufficiency
Respiratory Failure

Additional relevant MeSH terms:
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases