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

Not Applicable

Recruiting

• Conditions: COPD Exacerbation; Noninvasive Ventilation; COPD Exacerbation Acute; Emergency Medical Services
• Interventions: Other: Non-invasive ventilation

• Registration Number: NCT06211920
• Lead Sponsor: Central Denmark Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-07
• Study Start: 2023-12-08
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-09
• Last Update Submitted: 2024-01-09
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-invasive ventilation (NIV) + standard medical treatment	Non-invasive ventilation	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.

Primary Outcome Measures

Name	Time	Method
The change in pH observed during the prehospital treatment period.	During the prehospital treatment for a maximum of 2 hours.	pH will be measured before randomization in the prehospital setting and at arrival at the emergency department. The change in pH will be compared between the two groups.

Secondary Outcome Measures

Name	Time	Method
Proportion treated with invasive respiratory treatment.	During both the prehospital treatment and the entire hospital admission. Assessed up to 30 days.	The outcome will be compared between the two groups.
Length of hospital stay.	From time of admission and up until discharge. Assessed up to 30 days.	The outcome will be compared between the two groups.
Mortality (in-hospital and 30 days after admission).	During the length of hospital stay and up until 30 days after admission.	The outcome will be compared between the two groups.
Prehospital treatment time (both on-scene time and transport time).	During the prehospital treatment for a maximum of 2 hours.	The outcome will be compared between the two groups.
Overall time with a NIV-mask on.	From time of randomization and during the entire admission. Assessed up to 30 days.	NIV treatment time will be registrered in both groups on a schematic form. The outcome will be compared between the two groups.
The change in pH 2 hours from the initial prehospital ABG analysis.	2 hours from the initial prehospital ABG analysis.	pH will be measured before randomization in the prehospital setting and again after 2 hours. The change in pH will be compared between the two groups.

Trial Locations

Locations (1)

Prehospital Emegency Medical Service, Central Denmark Region, Denmark; 🇩🇰 Aarhus N, Central Denmark Region, Denmark