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High Flow Nasal Cannula for COPD

N/A
Waitlist Available
Led By Nicholas Hill, MD
Research Sponsored by Tufts Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Hospital admission for acute exacerbation of COPD defined by 2018 GOLD report as acute worsening of respiratory symptoms (more than baseline cough, sputum purulence or volume, dyspnea or wheeze) that result in additional therapy
Known COPD or high probability of the disease according to treating physician based on clinical history, physical examination and chest imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sputum sample will be collected at time = 24 +/-2 hours
Awards & highlights

Study Summary

This trial is investigating whether high flow nasal cannula (HFNC), which is a modality that provides humidified and warm oxygenated air at flow of upto 60L/min, can help with sputum clearance in COPD patients during an acute exacerbation.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly stated here, potential side effects of using HFNC may include discomfort in the nose or throat due to airflow pressure; dryness despite humidification; possible nosebleeds; and skin irritation around the nostrils.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was hospitalized for a severe worsening of my COPD symptoms.
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My doctor suspects or has diagnosed me with COPD based on my symptoms and chest scans.
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I have more sputum than usual, it's changed color, or I'm having trouble coughing it up.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sputum sample will be collected at time = 6 +/-2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and sputum sample will be collected at time = 6 +/-2 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clearability of sputum sample at 24 hours
Clearability of sputum sample at 6 hours
Clearability of sputum sample at baseline
+3 more
Secondary outcome measures
Change in cough frequency and easiness
Change in cough severity
Number of participants with need for escalation of care

Trial Design

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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Flow Nasal Cannula
2016
N/A
~270

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityOTHER
700 Previous Clinical Trials
22,886,733 Total Patients Enrolled
Tufts Medical CenterLead Sponsor
256 Previous Clinical Trials
255,697 Total Patients Enrolled
Nicholas Hill, MDPrincipal InvestigatorTufts Medical Center
2 Previous Clinical Trials
127 Total Patients Enrolled
~5 spots leftby Feb 2025
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