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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00885898
Acronym
NIV
Enrollment
51
Registered
2009-04-22
Start date
2005-03-31
Completion date
2009-04-30
Last updated
2009-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure, Respiratory Insufficiency

Keywords

Respiratory Insufficiency, Respiratory Failure

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.

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.

Interventions

PROCEDURENon-invasive-ventilation

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

PROCEDUREconventional treatment

oxygen, diuretics, bronchodilators, positive inotropic drugs

Sponsors

University of Göttingen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
28-day-mortality, ICU-days, respirator-days, SAPS, SOFA II, complications30 days after enrollment

Secondary

MeasureTime frame
out-of-hospital incidence of invasive ventilation, effect on SpO2, CO2, respiratory rate, heart rate and blood pressure30 days after enrollment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026