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Prehospital Non-invasive Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Recruiting
18 years of age
Both
Phase N/A

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Overview

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.

Eligibility

Inclusion Criteria:

  1. Age greater than or equal to 18 years.
  2. Medical history of COPD.
  3. Unable to give informed consent ("Inhabil" in Danish) based on the criteria below
  4. Respiratory acidosis with a PaCO2 of > 6,0 kPa and a pH of < 7,30.

    And one of the following:

  5. Respiratory rate of > 25 per minute.
  6. Hypoxia with a PaO2 < 7 kPa and/or a saturation < 88% without oxygen administered.

Exclusion Criteria:

  1. Upper gastrointestinal hemorrhage or vomiting.
  2. Anatomical abnormality that precludes the use of an oro-nasal interface.
  3. Suspicion of pneumothorax.
  4. Cardiac or respiratory arrest.
  5. Uncontrollable malignant arrhythmia.
  6. Refractory shock (systolic blood pressure < 90 mmHg) despite fluids and/or vasoactive drugs given.
  7. Required orotracheal intubation.
  8. Suspected upper airway obstruction.
  9. No indication for life-prolonging treatment with NIV.

Study details

COPD Exacerbation, COPD Exacerbation Acute, Noninvasive Ventilation, Emergency Medical Services

NCT06211920

Central Denmark Region

26 January 2024

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