Closed Loop Oxygen Control in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Nasal High Flow in the Hospital
Closed Loop Oxygen Control in COPD Patients Treated With Nasal High Flow in the Hospital
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 22 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether the Airvo 3 device in OptiO2 mode keeps blood oxygen levels in the target range better than oxygen adjusted by hand. It is for adults in the hospital with COPD, a long-term lung disease, who have low blood oxygen or trouble breathing and need high-flow oxygen through the nose.
The trial aims to evaluate whether the Airvo 3 device in OptiO2 mode can maintain patients' SpO2 levels within the target range better than manual oxygen titration in hospitalized COPD patients with hypoxemia/respiratory distress.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Can understand the study and agree to take part.
- Are age 22 or older.
- Are in the hospital with low blood oxygen or trouble breathing.
- Have COPD, a long-term lung disease.
- Use or qualify for high-flow air through the nose with added oxygen, at least 25 liters per minute, as judged by the study doctor.
- Are expected to need oxygen and high-flow treatment for more than 24 hours, even if there are breaks.
Who can't join
- Use or need noninvasive ventilation, a treatment that helps breathing through a mask, under the listed medical guidelines.
- Have a top blood pressure number below 90, or need medicines to support blood pressure or heart pumping.
- Are receiving end-of-life care.
- Have nose or face problems that prevent high-flow treatment, or cannot use a stick-on finger sensor to measure blood oxygen, as judged by the study doctor.
- Are pregnant or breastfeeding.
- Have problems with thinking or staying aware that prevent understanding and agreeing to the study.
- Have another condition the study doctor believes makes joining unsafe, or an active illness likely to greatly affect your health in the next 30 days.
- Have already taken part in this trial.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Has cognitive ability to provide informed consent * Aged 22 years or older * Hospitalized with hypoxemia/respiratory distress * Diagnosis of COPD * Candidate for/currently prescribed nasal high flow (flow rate of at least 25 L/min) with supplemental oxygen, as assessed by the investigator * Expected duration of oxygen and nasal high flow therapy \>24 hours (not necessarily continuous) Exclusion Criteria: * Receiving Non Invasive Ventilation (NIV) or indicated for NIV as per European Respiratory Society /American Thoracic Society guidelines * Hemodynamic instability (systolic blood pressure \<90mmHg or requirement for vasopressor or inotropic support) * Patient receiving end of life care * Nasal or facial conditions precluding use of nasal high flow * Pregnancy or breastfeeding * Cognitive impairment or impaired consciousness precluding informed consent * Unsuitable for adhesive finger pulse oximetry, as assessed by the investigator * Any other condition which, at the investigator's discretion, is believed to present a safety risk to the patient if included * The presence of any active comorbidities that affect the patient's condition importantly in the next 30 days, as assessed by the investigator * Has already participated in this clinical trial
Study sites (4)
AL
- The University of Alabama at Birmingham · Birmingham, AL 35294Raymond C Wade · Study contact · 205-934-2490 · rcwade@uab.eduMore trials in Birmingham
IA
- Central Iowa Hospital Corp - UnityPoint Health · Des Moines, IA 50309Matthew Trump · Study contact · 515-205-4013 · mtrump@iowaclinic.comMore trials in Des Moines
NY
- Icahn School of Medicine at Mount Sinai · New York, NY 10029Kathryn Dubowski · Study contact · 212-420-2377 · Kathryn.Dubowski@mountsinai.orgMore trials in New York
PA
- Temple University Hospital · Philadelphia, PA 19140Gerard Criner · Study contact · 215-707-8113 · Gerard.Criner@tuhs.temple.eduMore trials in Philadelphia