Automated oxygen adjustment for patients with acute COPD exacerbation
Reduction of Length of Stay by Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop
This study tests if using a device to automatically adjust oxygen levels can help people with acute COPD flare-ups leave the hospital sooner compared to those who get oxygen adjusted manually.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Quebec) |
| Trial ID | NCT03835741 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the FreeO2 device for automated oxygen adjustment in patients experiencing acute exacerbations of COPD. It compares the outcomes of patients managed with automated titration against those receiving manual oxygen titration. The primary focus is to determine if the automated approach can reduce the length of hospital stays for these patients. Participants will be randomly assigned to either the FreeO2 group or the manual titration group, and their hospital stay duration will be monitored and analyzed.
Who should consider this trial
Good fit: Ideal candidates are adults over 40 with a history of COPD or suspected COPD experiencing an acute exacerbation.
Not a fit: Patients with COPD exacerbations related to conditions like pulmonary embolism or those requiring advanced respiratory support will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly shorten hospital stays for patients with acute COPD exacerbations.
How similar studies have performed: Other studies have shown promise in using automated oxygen titration, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * COPD or suspected COPD ( Age\>40, active or smoking history \> 10pack/years), - * Acute exacerbation (increasing dyspnea recently) * One or more of the following criteria: increased sputum, modification of sputum purulence,increased dyspnea, * Moderate oxygen therapy: Oxygen flow \< 8 lpm (or FiO2 \< 0.60) to maintain a SpO2 \>or = 92% (for long term oxygen therapy, the oxygen flow must be greater than baseline flow to maintain SpO2 \> or = 92%) Exclusion Criteria: * Patient refusal * COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiac pulmonary edema, pneumothorax or sedative overdose * No SpO2 signal * Encephalopathy score \> 2 * Delirium * Other respiratory support needed (intubation or NIV) * Patient on withdrawal life support * Advance neoplasia (palliative stage) or terminal respiratory distress * Unavailability of FreeO2 device at the randomisation * Non optimal patient collaboration
Where this trial is running
Quebec
- Institut Universitaire de Cardiologie et de Pneumologie de Québec — Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: François Lellouche
- Email: francois.lellouche@criucpq.ulaval.ca
- Phone: 4186568711
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.