Trials / Unknown
UnknownNCT06211920
Prehospital Non-invasive Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Prehospital Use of Non-invasive Ventilation for Acute Respiratory Failure Due to Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Central Denmark Region · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 obstructive pulmonary disease (AECOPD) based on in-hospital criteria, should be used in the prehospital setting. This is performed with the introduction of prehospital arterial blood gas analyzation. The primary objective is: • To determine if early prehospital applied NIV together with standard medical treatment will affect arterial pH at hospital arrival in patients with ARF due to AECOPD. Participants in the intervention will receive Non-invasive ventilation together with standard medical treatment. The intervention will be compared to standard medical treatment alone, that may include inhaled bronchodilators, intravenous corticosteroids, and titrated oxygen supplementation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Non-invasive ventilation | The application of NIV will be performed using af a facemask as soon as possible after the patient has been randomized by opening the opaque envelope. All patients will receive the same standardized ventilator settings at initiation. The IPAP will be set at 12 cm H2O and the PEEP at 5 cm H2O. Oxygen delivery will be adjusted to an arterial oxygen saturation of 88-92%. Further adjustment of ventilator settings and evaluation of treatment effect will be at the discretion of the prehospital physician. |
Timeline
- Start date
- 2023-12-08
- Primary completion
- 2024-12-31
- Completion
- 2025-01-30
- First posted
- 2024-01-18
- Last updated
- 2024-01-18
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT06211920. Inclusion in this directory is not an endorsement.