High Flow Nasal Cannula for COPD

Overseen By Nicholas S Hill, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts Medical Center

Disqualifiers: Bronchiectasis, Cystic fibrosis, Coma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 24 hours

40 Participants Needed

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.

Research Team

Nicholas S Hill, MD

Principal Investigator

Tufts Medical Center

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to receive either high flow nasal cannula (HFNC) or conventional flow nasal oxygen (CFNO) for 24 hours

24 hours

Continuous monitoring during hospital stay

Follow-up

Participants are monitored for changes in sputum clearability and wettability, as well as cough severity and frequency

24 hours

Monitoring at baseline, 6 hours, and 24 hours

Post-treatment observation

Participants are observed for any need for escalation of care, including non-invasive ventilation or transfer to higher level of care

Up to 24 hours

Treatment Details

Interventions

• High Flow Nasal Cannula

Trial Overview 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.

Participant Groups

Group I: High flow nasal cannula (HFNC) group Experimental Treatment 1 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) group Active Control 1 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).

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+