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

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Tufts Medical Center
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Updated on 16 February 2024
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pulmonary disease
dyspnea
respiratory distress
wheezing
cough
obstruction
carbon dioxide
respiratory symptoms
respiratory symptom
acute exacerbation of chronic obstructive pulmonary disease
acute copd exacerbations
blood carbon dioxide
acute disease
throat
acute exacerbation of copd
lung disorder

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 C) 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.

Details
Condition Chronic Obstructive Lung Disease, Chronic Obstructive Lung Disease, COPD Exacerbation, Airflow Obstruction
Age 18years - 100years
Treatment High Flow Nasal Cannula
Clinical Study IdentifierNCT04217746
SponsorTufts Medical Center
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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pulmonary disease
dyspnea
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wheezing
cough
obstruction
carbon dioxide
respiratory symptoms
respiratory symptom
acute exacerbation of chronic obstructive pulmonary disease
acute copd exacerbations
blood carbon dioxide
acute disease
throat
acute exacerbation of copd
lung disorder

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