High Flow Nasal Cannula for COPD

Recruiting in Palo Alto (17 mi)

Overseen byNicholas S Hill, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Tufts Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?Acute exacerbation of COPD usually presents with more sputum production leading to worsening airflow obstruction. Often patients complain of sensation of sputum (phlegm) stuck in throat, which leads to worsening cough and respiratory distress. In an acute exacerbation setting high flow nasal cannula (HFNC), which is a modality that provides humidified and warm oxygenated air at flow of upto 60L/min, has shown to reduce blood carbon dioxide level and respiratory rate. However, studies investigating other effects of HFNC in this setting are lacking. To investigators' knowledge, this is the first study investigating effects of HFNC on sputum clearance in COPD patients. The purpose of the study is to determine the effects of HFNC on sputum clearance in acute exacerbation of COPD. Primary objective of the study is to determine whether HFNC improves clearability and wettability of sputum produced during acute exacerbation of COPD. Secondary objectives of the study include subjective assessment of cough severity as well as need for escalation of care after HFNC use versus conventional flow nasal oxygen (CFNO) use.

Eligibility Criteria

This trial is for adults over 18 hospitalized with a worsening of COPD symptoms, like more coughing or changes in sputum. They must have known COPD or a high chance of it based on their doctor's assessment and tests. People can't join if they're bleeding heavily from the lungs, can't follow the study plan, are in other overlapping studies, can't consent, are very unconscious or in shock, need breathing support machines right away, have weak coughs due to muscle issues, face injuries that prevent wearing nasal cannula properly, have certain lung conditions like bronchiectasis or cystic fibrosis, or aren’t expected to survive their hospital stay.

Inclusion Criteria

I was hospitalized for a severe worsening of my COPD symptoms.

My doctor suspects or has diagnosed me with COPD based on my symptoms and chest scans.

I have more sputum than usual, it's changed color, or I'm having trouble coughing it up.

+1 more

Exclusion Criteria

You are not expected to survive the hospital stay.

Inability to obtain informed consent from the patient or legally authorized representative

Enrollment in other investigative protocols with apparent overlap

+8 more

Participant Groups

The study is testing if High Flow Nasal Cannula (HFNC), which gives warm and humid oxygen at high speeds up to 60L/min helps clear out phlegm better during severe COPD flare-ups compared to standard oxygen therapy. It also looks at whether HFNC affects how bad patients' coughs feel and if it reduces the need for more intense treatments.

2Treatment groups

Experimental Treatment

Active Control

Group I: High flow nasal cannula (HFNC) groupExperimental Treatment1 Intervention

The HFNC group will receive heated (approximately 37 ⁰C) and humidified (100% relative humidity) oxygenated gas delivered at high flow at 50L/min. Flow could be decreased to as low as 30L/min and temperature to 31 ⁰C as per patient's tolerance.

Group II: Conventional flow nasal oxygen (CFNO) groupActive Control1 Intervention

The conventional flow nasal oxygen (CFNO) group is the control group which will receive ambient temperature and non-humidified oxygen delivered at flow rates of up to 8L/min (standard care).