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

University of Göttingen

Status: Completed

Conditions: Respiratory Failure; Respiratory Insufficiency

Treatments: Procedure: conventional treatment; Procedure: Non-invasive-ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00885898

40/11/04 UGoettingen

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

1

Active Comparator group

Description:

"Non-invasive ventilation"

Treatment:

Procedure: Non-invasive-ventilation

2

Active Comparator group

Description:

"Conventional"

Treatment:

Procedure: conventional treatment