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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ sputum sample will be collected at time = 6 +/-2 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sputum sample will be collected at time = 6 +/-2 hours
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 moreSecondary 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
698 Previous Clinical Trials
22,884,968 Total Patients Enrolled
Tufts Medical CenterLead Sponsor
253 Previous Clinical Trials
253,358 Total Patients Enrolled
Nicholas Hill, MDPrincipal InvestigatorTufts Medical Center
2 Previous Clinical Trials
127 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are enrolled in this research investigation?
"Affirmative, according to clinicaltrials.gov this medical investigation is currently accepting participants; it was initially posted on February 1st 2020 and the most current update came March 18th 2022. 40 patients must be recruited from one trial location."
Answered by AI
Is this research still enrolling participants?
"Affirmative. Clinicaltrials.gov has evidence that this clinical experiment is presently recruiting participants, with the original post made on February 1st 2020 and latest updates as of March 18th 2022. 40 individuals are being sought after from a single medical center."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
How old are they?
65+
18 - 65
What site did they apply to?
Tufts Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Most responsive sites:
- Tufts Medical Center: < 24 hours
Average response time
- < 2 Days
Typically responds via
Email
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