Clinical trial NCT06211920: Prehospital Non-invasive Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official title: Prehospital Use of Non-invasive Ventilation for Acute Respiratory Failure Due to Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD Exacerbation
COPD Exacerbation Acute
Noninvasive Ventilation
Emergency Medical Services
Lead sponsor: Central Denmark Region
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Investigator-initiated, randomized 1:1, clinical trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The change in pH observed during the prehospital treatment period.
timeFrame: During the prehospital treatment for a maximum of 2 hours.
Secondary outcomes:
measure: Overall time with a NIV-mask on.
timeFrame: From time of randomization and during the entire admission. Assessed up to 30 days.
measure: Proportion treated with invasive respiratory treatment.
timeFrame: During both the prehospital treatment and the entire hospital admission. Assessed up to 30 days.
measure: Length of hospital stay.
timeFrame: From time of admission and up until discharge. Assessed up to 30 days.
measure: The change in pH 2 hours from the initial prehospital ABG analysis.
timeFrame: 2 hours from the initial prehospital ABG analysis.
measure: Mortality (in-hospital and 30 days after admission).
timeFrame: During the length of hospital stay and up until 30 days after admission.
measure: Prehospital treatment time (both on-scene time and transport time).
timeFrame: During the prehospital treatment for a maximum of 2 hours.
Other outcomes:
measure: Correlation between venous and arterial pH.
timeFrame: During the prehospital treatment for a maximum of 2 hours.
measure: Correlation between PaCO2 and the partial pressure of CO2 in venous blood (PvCO2).
timeFrame: During the prehospital treatment for a maximum of 2 hours.
measure: 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.
timeFrame: During the prehospital treatment for a maximum of 2 hours.
Locations:
city: Aarhus N
country: Denmark
facility: Prehospital Emegency Medical Service, Central Denmark Region, Denmark
state: Central Denmark Region
Study officials:
affiliation: Research and development, The Prehospital Department in The Central Denmark Region
name: Jesper H Haunstrup Brendel, MD
role: PRINCIPAL_INVESTIGATOR
References: