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Effects of High Flow Nasal Cannula on Sputum Clearance in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD Exacerbation, Airflow Obstruction

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Flow Nasal Cannula
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring high flow nasal cannula, sputum, clearability, wetability, chronic obstructive pulmonary disease, COPD exacerbation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Known COPD or high probability of the disease according to treating physician based on clinical history, physical examination and chest imaging.
  3. 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.
  4. Presence of one or more of following: increase in sputum production, change in sputum color or difficulty in expectorating sputum.

Exclusion Criteria:

  1. Inability to obtain informed consent from the patient or legally authorized representative.
  2. Inability of the subject to cooperate with protocol.
  3. Presence of idiopathic bronchiectasis or cystic fibrosis.
  4. Patients with poor short term prognosis not expected to survive the hospitalization.
  5. Massive hemoptysis.
  6. Patients presenting with coma (Glasgow coma scale <10) or circulatory shock.
  7. Respiratory failure requiring non-invasive ventilation (NIV) or endotracheal intubation.
  8. Severely impaired cough, impaired swallowing or chronic aspiration due to neuromuscular disorder.
  9. Facial deformity or injury leading to difficulty in wearing high flow nasal cannula appropriately.
  10. Enrollment in other investigative protocols with apparent overlap.
  11. Prisoners

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High flow nasal cannula (HFNC) group

Conventional flow nasal oxygen (CFNO) group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Clearability of sputum sample at baseline
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Clearability of sputum sample at 6 hours
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Clearability of sputum sample at 24 hours
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Wettability of sputum sample at baseline
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.
Wettability of sputum sample at 6 hours
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.
Wettability of sputum sample at 24 hours
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.

Secondary Outcome Measures

Change in cough severity
Subjective assessment of change in cough severity using a 0mm to 100mm visual analogue scale (VAS) with 0mm being no cough to 100mm being worse cough ever.
Change in cough frequency and easiness
Subjective assessment of cough frequency and easiness using Breathlessness, Cough and Sputum Scale (BCSS) with score ranging from 0 to 12, 0 being no cough, no difficulty breathing and no trouble due to sputum and 12 being severe difficulty breathing, constant cough and constant trouble due to sputum.
Number of participants with need for escalation of care
Need for escalation of care including non-invasive ventilation (NIV), endotracheal intubation or transfer to higher level of care.

Full Information

First Posted
December 16, 2019
Last Updated
September 6, 2023
Sponsor
Tufts Medical Center
Collaborators
Virginia Commonwealth University
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1. Study Identification

Unique Protocol Identification Number
NCT04217746
Brief Title
Effects of High Flow Nasal Cannula on Sputum Clearance in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Official Title
Effects of High Flow Nasal Cannula on Sputum Clearance in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
Virginia Commonwealth University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and the 4th leading cause of mortality in the world. Acute exacerbation of COPD usually presents with more sputum production leading to worsening airflow obstruction. During an exacerbation, high flow nasal cannula (HFNC) 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. Patients with a diagnosis of acute exacerbation of COPD who are receiving oxygen therapy via conventional nasal cannula or are on room air will be randomized into high flow nasal cannula (HFNC) or conventional flow nasal oxygen (CFNO) group for 24 hours. HFNC group will receive heated (approximately 37 ⁰C) and humidified (100% relative humidity) oxygenated gas delivered at high flow at 50L/min. CFNO group will receive ambient temperate and non-humidified oxygenated gas delivered at flow of up to 8L/min (standard care). Sputum sample will be collected at time = 0 hours (baseline), 4 +/- 1 hours, 8 +/- 2 hours and 24 +/- 2 hours. Visual analogue score (VAS) regarding cough severity and Breathlessness, Cough and Sputum Scale (BCSS) regarding cough frequency and ease will be obtained at time = 0 and 24 hours. Primary outcomes of the study are the difference in clearability and wettability of sputum sample. Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability. Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability. Secondary outcomes include subjective assessment of cough using VAS and BCSS scales, as well as need for escalation of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD Exacerbation, Airflow Obstruction
Keywords
high flow nasal cannula, sputum, clearability, wetability, chronic obstructive pulmonary disease, COPD exacerbation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High flow nasal cannula (HFNC) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional flow nasal oxygen (CFNO) group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Cannula
Other Intervention Name(s)
Fisher and Paykel AIRVO humidified high flow system
Intervention Description
The HFNC group will receive heated and humidified oxygenated gas delivered at high flow.
Primary Outcome Measure Information:
Title
Clearability of sputum sample at baseline
Description
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Time Frame
Sputum sample will be collected at time = 0 hours (baseline)
Title
Clearability of sputum sample at 6 hours
Description
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Time Frame
Sputum sample will be collected at time = 6 +/- 2 hours
Title
Clearability of sputum sample at 24 hours
Description
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Time Frame
Sputum sample will be collected at time = 24 +/- 2 hours
Title
Wettability of sputum sample at baseline
Description
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.
Time Frame
Sputum sample will be collected at time = 0 hours (baseline)
Title
Wettability of sputum sample at 6 hours
Description
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.
Time Frame
Sputum sample will be collected at time = 6 +/-2 hours
Title
Wettability of sputum sample at 24 hours
Description
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.
Time Frame
Sputum sample will be collected at time = 24 +/-2 hours
Secondary Outcome Measure Information:
Title
Change in cough severity
Description
Subjective assessment of change in cough severity using a 0mm to 100mm visual analogue scale (VAS) with 0mm being no cough to 100mm being worse cough ever.
Time Frame
Visual analogue score regarding cough severity will be obtained at time = 0 hours (baseline), and time = 24 hours.
Title
Change in cough frequency and easiness
Description
Subjective assessment of cough frequency and easiness using Breathlessness, Cough and Sputum Scale (BCSS) with score ranging from 0 to 12, 0 being no cough, no difficulty breathing and no trouble due to sputum and 12 being severe difficulty breathing, constant cough and constant trouble due to sputum.
Time Frame
Breathlessness, Cough and Sputum Scale (BCSS) regarding cough frequency and ease will be obtained at time = 0 hours (baseline), and time = 24 hours.
Title
Number of participants with need for escalation of care
Description
Need for escalation of care including non-invasive ventilation (NIV), endotracheal intubation or transfer to higher level of care.
Time Frame
Need for escalation will be documented at any time throughout subject's participation which is upto 24 hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old Known COPD or high probability of the disease according to treating physician based on clinical history, physical examination and chest imaging. 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. Presence of one or more of following: increase in sputum production, change in sputum color or difficulty in expectorating sputum. Exclusion Criteria: Inability to obtain informed consent from the patient or legally authorized representative. Inability of the subject to cooperate with protocol. Presence of idiopathic bronchiectasis or cystic fibrosis. Patients with poor short term prognosis not expected to survive the hospitalization. Massive hemoptysis. Patients presenting with coma (Glasgow coma scale <10) or circulatory shock. Respiratory failure requiring non-invasive ventilation (NIV) or endotracheal intubation. Severely impaired cough, impaired swallowing or chronic aspiration due to neuromuscular disorder. Facial deformity or injury leading to difficulty in wearing high flow nasal cannula appropriately. Enrollment in other investigative protocols with apparent overlap. Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Hill, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Currently there is no plan to share IPD.

Learn more about this trial

Effects of High Flow Nasal Cannula on Sputum Clearance in Acute Exacerbation of Chronic Obstructive Pulmonary Disease

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