COPD ExacerbationPRENIVNCT06211920
Prehospital Non-invasive Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing Non-invasive ventilation in people with COPD Exacerbation and COPD Exacerbation Acute, run by Central Denmark Region at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Exacerbation, COPD Exacerbation Acute, Noninvasive Ventilation
- What is being tested?
- Non-invasive ventilation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Dec 2023to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years.
- Medical history of COPD.
- Unable to give informed consent ("Inhabil" in Danish) based on the criteria below
- Respiratory acidosis with a PaCO2 of > 6,0 kPa and a pH of < 7,30.
- And one of the following:
- Respiratory rate of > 25 per minute.
- Hypoxia with a PaO2 < 7 kPa and/or a saturation < 88% without oxygen administered.
Who cannot join
- Upper gastrointestinal hemorrhage or vomiting.
- Anatomical abnormality that precludes the use of an oro-nasal interface.
- Suspicion of pneumothorax.
- Cardiac or respiratory arrest.
- Uncontrollable malignant arrhythmia.
- Refractory shock (systolic blood pressure < 90 mmHg) despite fluids and/or vasoactive drugs given.
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- Required orotracheal intubation.
- Suspected upper airway obstruction.
- No indication for life-prolonging treatment with NIV.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Prehospital Emegency Medical Service, Central Denmark Region, Denmark
Aarhus N, Central Jutland, 8200
Jesper H Brendel, MD, 004530504012, jespholb@rm.dk
Jesper Haunstrup Brendel, MD
About this study
Official title: Prehospital Use of Non-invasive Ventilation for Acute Respiratory Failure Due to Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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
- Being tested
- Non-invasive ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilationOther
Also called Standard medical treatment alone
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive ventilation (NIV) + standard medical treatment | Experimental | 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. Receives: Other: Non-invasive ventilation |
| Standard medical treatment alone | No intervention | 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%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the prehospital treatment for a maximum of 2 hours.
Secondary outcomes (6)
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.
Measured: From time of randomization and during the entire admission. Assessed up to 30 days.
Proportion treated with invasive respiratory treatment.
The outcome will be compared between the two groups.
Measured: During both the prehospital treatment and the entire hospital admission. Assessed up to 30 days.
Length of hospital stay.
The outcome will be compared between the two groups.
Measured: From time of admission and up until discharge. Assessed up to 30 days.
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.
Measured: 2 hours from the initial prehospital ABG analysis.
Mortality (in-hospital and 30 days after admission).
The outcome will be compared between the two groups.
Measured: During the length of hospital stay and up until 30 days after admission.
Prehospital treatment time (both on-scene time and transport time).
The outcome will be compared between the two groups.
Measured: During the prehospital treatment for a maximum of 2 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start8 Dec 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Investigator-initiated, randomized 1:1, clinical trial
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Denmark Region
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesper H Haunstrup Brendel, MD, Principal investigator, Research and development, The Prehospital Department in The Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211920
- Sponsor's protocol ID
- 97289
- Acronym
- PRENIV
- Status last verified
- Jan 2024
- First submitted
- 7 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing. Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. Data will be completely anonymized according to Danish law. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data.
Publications
Brendel JH, Andersen LW, Skaarup SH, Dissing T, Nielsen AG, Milandt NF, Espelund US, Irion LF, Mortensen LR, Larsen KM, Petersen JAK. Prehospital Use of Non-Invasive Ventilation for Acute Respiratory Failure due to Acute Exacerbation of Chronic Obstructive Pulmonary Disease. A Randomised Trial. Acta Anaesthesiol Scand. 2026 Jul;70(6):e70269. doi: 10.1111/aas.70269.
PubMed 42219224
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehospital Use of Non-invasive Ventilation for Acute Respiratory Failure Due to Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06211920
- Acronym / sponsor ID
- PRENIV / 97289
- Conditions
- COPD Exacerbation, COPD Exacerbation Acute, Noninvasive Ventilation, Emergency Medical Services
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Central Denmark RegionUniversity, hospital or other
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Investigator-initiated, randomized 1:1, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Non-invasive ventilation (NIV) + standard medical treatment | Experimental | Other: Non-invasive ventilationThe 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. |
| Standard medical treatment alone | No intervention | –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%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age greater than or equal to 18 years.
- Medical history of COPD.
- Unable to give informed consent ("Inhabil" in Danish) based on the criteria below
- Respiratory acidosis with a PaCO2 of > 6,0 kPa and a pH of < 7,30.
- Respiratory rate of > 25 per minute.
Key exclusion criteria (9 listed)
- Upper gastrointestinal hemorrhage or vomiting.
- Anatomical abnormality that precludes the use of an oro-nasal interface.
- Suspicion of pneumothorax.
- Cardiac or respiratory arrest.
- Uncontrollable malignant arrhythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive ventilationAlso: Standard medical treatment aloneThe 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. | Other | Non-invasive ventilation (NIV) + standard medical treatment |
Primary outcome
The change in pH observed during the prehospital treatment period.
Time frame: 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.
6 secondary outcomes
Overall time with a NIV-mask on.
Time frame: From time of randomization and during the entire admission. Assessed up to 30 days.
Proportion treated with invasive respiratory treatment.
Time frame: During both the prehospital treatment and the entire hospital admission. Assessed up to 30 days.
Length of hospital stay.
Time frame: From time of admission and up until discharge. Assessed up to 30 days.
The change in pH 2 hours from the initial prehospital ABG analysis.
Time frame: 2 hours from the initial prehospital ABG analysis.
Mortality (in-hospital and 30 days after admission).
Time frame: During the length of hospital stay and up until 30 days after admission.
Prehospital treatment time (both on-scene time and transport time).
Time frame: During the prehospital treatment for a maximum of 2 hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Derived from this study: PubMed 42219224Brendel JH, Andersen LW, Skaarup SH, Dissing T, Nielsen AG, Milandt NF, Espelund US, Irion LF, Mortensen LR, Larsen KM, Petersen JAK. Prehospital Use of Non-Invasive Ventilation for Acute Respiratory Failure due to Acute Exacerbation of Chronic Obstructive Pulmonary Disease. A Randomised Trial. Acta Anaesthesiol Scand. 2026 Jul;70(6):e70269. doi: 10.1111/aas.70269.
- Individual participant dataSharing planned: Yes. Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing. Procedures, including re-coding of key variables, will be put in place to allow for complete de-identification of the data. Data will be completely anonymized according to Danish law. All relevant trial-related documents, including the protocol, data dictionary, and the main statistical code, will be shared along with the data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper H Haunstrup Brendel, MD principal investigator
Research and development, The Prehospital Department in The Central Denmark Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive ventilation in people with COPD Exacerbation and COPD Exacerbation Acute, run by Central Denmark Region at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesper H Brendel, MD. (004530504012, jespholb@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in pH observed during the prehospital treatment period. (time frame: During the prehospital treatment for a maximum of 2 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06211920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.