Status:
RECRUITING
Prehospital Non-invasive Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Central Denmark Region
Conditions:
COPD Exacerbation
COPD Exacerbation Acute
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test if treatment with prehospital Non-invasive ventilation (NIV) for patients with acute respiratory failure (ARF), due to acute exacerbation of chronic obstruct...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years.
- Medical history of COPD.
- Unable to give informed consent ("Inhabil" in Danish) based on the criteria below
- Respiratory acidosis with a PaCO2 of \> 6,0 kPa and a pH of \< 7,30.
- And one of the following:
- Respiratory rate of \> 25 per minute.
- Hypoxia with a PaO2 \< 7 kPa and/or a saturation \< 88% without oxygen administered.
Exclusion
- Upper gastrointestinal hemorrhage or vomiting.
- Anatomical abnormality that precludes the use of an oro-nasal interface.
- Suspicion of pneumothorax.
- Cardiac or respiratory arrest.
- Uncontrollable malignant arrhythmia.
- Refractory shock (systolic blood pressure \< 90 mmHg) despite fluids and/or vasoactive drugs given.
- Required orotracheal intubation.
- Suspected upper airway obstruction.
- No indication for life-prolonging treatment with NIV.
Key Trial Info
Start Date :
December 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06211920
Start Date
December 8 2023
End Date
January 30 2025
Last Update
January 18 2024
Active Locations (1)
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1
Prehospital Emegency Medical Service, Central Denmark Region, Denmark
Aarhus N, Central Jutland, Denmark, 8200