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

Central Denmark Region

Status: Enrolling

Conditions: Noninvasive Ventilation; COPD Exacerbation Acute; Emergency Medical Services; COPD Exacerbation

Treatments: Other: Non-invasive ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT06211920

97289

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Non-invasive ventilation (NIV) + standard medical treatment

Experimental group

Description:

The intervention will consist of application of NIV through a facemask. This will happen 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. These settings are preset on the ventilator used in the physician manned mobile emergency care unit (MECU) in the Central Denmark Region. 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. NIV will be administered together with standard medical treatment described below.

Treatment:

Other: Non-invasive ventilation

Standard medical treatment alone

No Intervention group

Description:

The standard treatment may include inhaled bronchodilators, intravenous corticosteroids, and titrated oxygen supplementation. Although this treatment is based on regional standard operating procedures (SOP), it may differ from patient to patient because it is based on the clinical judgement by the emergency physician in the MECU. Inhaled bronchodilators can be given in the form of Fenoterol and Ipratropium as a combination drug and/or Salbutamol. Both as a nebulizer solution. One dose (4 ml) of the combination drug contains 1,25 mg Fenoterol and 0,5 mg Ipratropium. Salbutamol will be administered in a concentration of 1 mg/ml. Five mg will be given initially, which can be repeated if necessary. Corticosteroids can be given in the form of Methylprednisolone 40-80 mg administered intravenously after establishing an intravenous access. Oxygen therapy will be delivered through a nasal cannula if possible or a non-rebreather mask to maintain an arterial saturation of 88-92%.