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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

Must not have

Patients presenting with coma (Glasgow coma scale <10) or circulatory shock

Facial deformity or injury leading to difficulty in wearing high flow nasal cannula appropriately

Timeline

Screening 3 weeks

Treatment Varies

Follow Up sputum sample will be collected at time = 24 +/-2 hours

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not in a coma or experiencing severe shock.

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I have a facial condition that makes it hard to use a high flow nasal cannula.

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I have trouble swallowing or coughing because of a muscle disorder.

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I have not experienced severe coughing up of blood.

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I need a machine to help me breathe.

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I have been diagnosed with bronchiectasis or cystic fibrosis.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clearability of sputum sample at 24 hours

Clearability of sputum sample at 6 hours

Clearability of sputum sample at baseline

+3 more

Secondary study objectives

Change in cough frequency and easiness

Change in cough severity

Number of participants with need for escalation of care

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~320

0 / 10Eligibility criteria met