Nasal high-flow therapy for COPD exacerbations
Nasal High-Flow Therapy to Treat COPD Exacerbations: a Matter of Monitoring and Controlling Settings?
NA · University Medical Center Groningen · NCT03564236
This study is testing if nasal high-flow therapy can help hospitalized patients with COPD recover better from flare-ups compared to standard care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Sex | All |
| Sponsor | University Medical Center Groningen (other) |
| Locations | 3 sites (Arnhem and 2 other locations) |
| Trial ID | NCT03564236 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy of nasal high-flow therapy (nHFT) in enhancing recovery from COPD exacerbations in hospitalized patients. It is a multicenter, randomized controlled trial comparing nHFT to standard care, aiming to include 136 patients. The study will also explore the underlying mechanisms of nHFT through neuromechanical and anatomical investigations. By understanding how nHFT works, the study seeks to optimize its application for COPD patients experiencing exacerbations.
Who should consider this trial
Good fit: Ideal candidates are hospitalized patients with COPD (GOLD stage II to IV) experiencing exacerbations and showing signs of compensated respiratory failure.
Not a fit: Patients with stable COPD or those not experiencing exacerbations may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve recovery times and quality of life for patients suffering from COPD exacerbations.
How similar studies have performed: Preliminary evidence suggests nHFT may be effective in stable COPD patients, but this approach in exacerbations is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients have to fulfil all of the following inclusion criteria: * History of COPD Global Initiative of Obstructive Lung Diseases (GOLD) stage II to IV (FEV1\< 80% of predicted with an FEV1/forced vital capacity (FVC) ratio \<70), with a history of at least 10 pack years smoking. * Being admitted to the hospital with a COPD exacerbation * Signs of compensated respiratory failure (hypercapnia (partial arterial carbon dioxide pressure (PaCO2) ≥ 6.0 kPa and/or hypoxemia (partial arterial oxygen pressure (PaO2) ≤ 8.0 kPa at room air), with pH \> 7.34 * At least 2 COPD exacerbations in the year prior to the index hospital admission (exacerbation defined as worsening of pulmonary symptoms requiring oral steroids and/or antibiotics and/or hospital admission) * Written informed consent is obtained Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * No lung function data available * The presence of another acute condition (e.g. pneumonia, acute congestive heart failure, pulmonary embolus) explaining or significantly contributing to the index admission * Inability to comply with the tests * The presence of another chronic lung disease (e.g. asthma, restrictive lung disease).
Where this trial is running
Arnhem and 2 other locations
- Rijnstate Hospital — Arnhem, Netherlands (RECRUITING)
- Albert Schweizer ziekenhuis — Dordrecht, Netherlands (RECRUITING)
- University Medical Center Groningen — Groningen, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Marieke L Duiverman, MD PhD
- Email: m.l.duiverman@umcg.nl
- Phone: 0031-50-3613200
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.
Conditions: COPD Exacerbation