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

COPD Exacerbation Clinical Trial

— PRENIV  

Official title:

Prehospital Use of Non-invasive Ventilation for Acute Respiratory Failure Due to Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06211920
• Other study ID #: 97289
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: January 2024
• Source: Central Denmark Region
• Contact: Jesper H Brendel, MD.
• Phone: 004530504012
• Email: jespholb[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: January 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• COPD Exacerbation
• COPD Exacerbation Acute
• Emergencies
• Emergency Medical Services
• Lung Diseases, Obstructive
• Noninvasive Ventilation
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
Denmark	Prehospital Emegency Medical Service, Central Denmark Region, Denmark	Aarhus N	Central Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Central Denmark Region

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between venous and arterial pH.		During the prehospital treatment for a maximum of 2 hours.
Other	Correlation between PaCO2 and the partial pressure of CO2 in venous blood (PvCO2).		During the prehospital treatment for a maximum of 2 hours.
Other	Correlation between "venous to arterial conversion" (v-TAC) and the results from the actual arterial blood gas analysis regarding pH, PaCO2 and PaO2 in all enrolled patients.	We will use a mathematical model (v-TAC) to arterialize the results from all the venous blood gas analysis from each enrolled patient. We will correlate these results regarding pH, PaCO2 and PaO2 with the results from the actual ABG analysis	During the prehospital treatment for a maximum of 2 hours.
Primary	The change in pH observed during the prehospital treatment period.	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.	During the prehospital treatment for a maximum of 2 hours.
Secondary	Overall time with a NIV-mask on.	NIV treatment time will be registrered in both groups on a schematic form. The outcome will be compared between the two groups.	From time of randomization and during the entire admission. Assessed up to 30 days.
Secondary	Proportion treated with invasive respiratory treatment.	The outcome will be compared between the two groups.	During both the prehospital treatment and the entire hospital admission. Assessed up to 30 days.
Secondary	Length of hospital stay.	The outcome will be compared between the two groups.	From time of admission and up until discharge. Assessed up to 30 days.
Secondary	The change in pH 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.	2 hours from the initial prehospital ABG analysis.
Secondary	Mortality (in-hospital and 30 days after admission).	The outcome will be compared between the two groups.	During the length of hospital stay and up until 30 days after admission.
Secondary	Prehospital treatment time (both on-scene time and transport time).	The outcome will be compared between the two groups.	During the prehospital treatment for a maximum of 2 hours.