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

NCT ID: NCT06211920

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-08
• Study Completion Date: 2025-01-30

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 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-invasive ventilation (NIV) + standard medical treatment

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.

Group Type: EXPERIMENTAL

Non-invasive ventilation

Intervention Type: OTHER

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.

Standard medical treatment alone

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%.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Standard medical treatment alone

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Denmark Region

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesper H Haunstrup Brendel, MD

Role: PRINCIPAL_INVESTIGATOR

Research and development, The Prehospital Department in The Central Denmark Region

Locations

Prehospital Emegency Medical Service, Central Denmark Region, Denmark

Aarhus N, Central Jutland, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jesper H Brendel, MD.

Role: CONTACT

jespholb@rm.dk

004530504012

Facility Contacts

Jesper H Brendel, MD

Role: primary

jespholb@rm.dk

004530504012

Other Identifiers

97289

Identifier Type: -

Identifier Source: org_study_id