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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04217746
• Other study ID #: IRB#13356
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: February 1, 2025

Study information

• Verified date: September 2023
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airflow Obstruction
• Chronic Obstructive Pulmonary Disease
• COPD Exacerbation
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• High Flow Nasal Cannula
The HFNC group will receive heated and humidified oxygenated gas delivered at high flow.

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Sputum sample will be collected at time = 0 hours (baseline)
Primary	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.	Sputum sample will be collected at time = 6 +/- 2 hours
Primary	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.	Sputum sample will be collected at time = 24 +/- 2 hours
Primary	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.	Sputum sample will be collected at time = 0 hours (baseline)
Primary	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.	Sputum sample will be collected at time = 6 +/-2 hours
Primary	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.	Sputum sample will be collected at time = 24 +/-2 hours
Secondary	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.	Visual analogue score regarding cough severity will be obtained at time = 0 hours (baseline), and time = 24 hours.
Secondary	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.	Breathlessness, Cough and Sputum Scale (BCSS) regarding cough frequency and ease will be obtained at time = 0 hours (baseline), and time = 24 hours.
Secondary	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.	Need for escalation will be documented at any time throughout subject's participation which is upto 24 hours.