COPD Exacerbation, COPD Exacerbation Acute, Emergency Medical Services, Noninvasive Ventilation
Conditions
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.
Interventions
OTHERNon-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.
Sponsors
Central Denmark Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the intervention, the clinicians performing the intervention cannot be blinded. This is also the case for patients along with any legally designated representatives at the scene. As it is common to note the prehospital treatment in the patient's medical records clinicians at the ED and/or ICU will not necessarily be blinded either. For the same reason, investigators involved in data entry will also not be blinded meaning that outcomes such as change in arterial pH are entered without blinding. However, there is little - if any - subjectivity in evaluating these outcomes and blinding is therefore likely of minor importance. A patient - or alternatively the consenting legally designated representatives - will not be informed of the allocation until the end of follow-up and only per request on the consent form.
Intervention model description
Investigator-initiated, randomized 1:1, clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | During the prehospital treatment for a maximum of 2 hours. | 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 |
| Correlation between venous and arterial pH. | During the prehospital treatment for a maximum of 2 hours. | — |
| Correlation between PaCO2 and the partial pressure of CO2 in venous blood (PvCO2). | During the prehospital treatment for a maximum of 2 hours. | — |
Countries
Denmark
Contacts
Primary ContactJesper H Brendel, MD.
Outcome results
None listed