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OpenTrials
Completed

NCT Number: NCT00885898

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

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.

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Key information

Conditions

Respiratory Insufficiency Respiration Disorders Respiratory Failure Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EMS

Göttingen, Lower Saxony, 37073, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-invasive-ventilation

Procedure

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

Conventional treatment

Procedure

oxygen, diuretics, bronchodilators, positive inotropic drugs

Primary outcomes

  1. 28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications

    Time frame: 30 days after enrollment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Göttingen

Other

Registry information

Official study title

Out-of-Hospital Non-Invasive Ventilation in Patients With Acute Respiratory Insufficiency

Acronym: NIV

Important dates

Study start
2005
Primary completion
2007
Study completion
2009
First posted
Apr 22, 2009
Registry last updated
Apr 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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