Using non-invasive ventilation before hospital for COPD flare-ups
Prehospital Use of Non-invasive Ventilation for Acute Respiratory Failure Due to Acute Exacerbation of Chronic Obstructive Pulmonary Disease
This study is testing if using a breathing machine before going to the hospital can help people with COPD flare-ups breathe better and feel improved when they arrive at the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Denmark Region Academic / other |
| Locations | 1 site (Aarhus N, Central Denmark Region) |
| Trial ID | NCT06211920 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of prehospital non-invasive ventilation (NIV) for patients experiencing acute respiratory failure due to exacerbations of chronic obstructive pulmonary disease (COPD). The study will compare the outcomes of patients receiving NIV alongside standard medical treatment to those receiving standard treatment alone. Key measurements will include arterial blood gas levels, particularly pH, upon hospital arrival. The trial seeks to determine if early intervention with NIV can improve patient outcomes in emergency settings.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a history of COPD who are experiencing acute respiratory failure.
Not a fit: Patients with conditions such as upper gastrointestinal hemorrhage, cardiac arrest, or those requiring intubation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved respiratory function and better outcomes for patients with acute COPD exacerbations.
How similar studies have performed: Other studies have shown promising results with non-invasive ventilation in similar acute settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aarhus N, Central Denmark Region
- Prehospital Emegency Medical Service, Central Denmark Region, Denmark — Aarhus N, Central Denmark Region, Denmark (Recruiting)
Study contacts
- Principal investigator: Jesper H Haunstrup Brendel, MD — Research and development, The Prehospital Department in The Central Denmark Region
- Study coordinator: Jesper H Brendel, MD.
- Email: jespholb@rm.dk
- Phone: 004530504012
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.