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Heated High Humidity After COPD Exacerbation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772626
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
Joshua Wald, McMaster University

Brief Summary:
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease usually caused by exposure to tobacco smoke which leads to chronic symptoms of shortness of breath, cough, and phlegm. COPD is one of the leading causes of disability and death in Canada. Individuals with COPD often have periodic worsening of their disease, called exacerbations, consisting of increased shortness of breath and often an increase in cough and phlegm. These exacerbations often lead to hospital admission and are associated with worsening symptoms and lung function over time. After an exacerbation individuals with COPD usually take several weeks to return to their previous state of health and many people with an exacerbation who are discharged from hospital return to the ER within 60. Heated humidified air has been shown to improve the clearance of mucous in the lungs for people with chronic lung disease. By providing patients at St. Joseph's Hospital who are discharged after a COPD exacerbation with a device for delivering heated high humidity air to use overnight it is hoped that these individuals will be able to more easily keep their lungs and airways free of mucous. This in turn may lead to improvement in their symptoms of shortness of breath, cough, and phlegm production as well as decreasing obstruction of the airways to reduce the risk of having to return to the emergency room or hospital.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Device: Heated Humidified High-flow Nasal Cannula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group non-randomized open label study of efficacy and feasibility. Comparison will be to historical controls.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Feasibility and Efficacy of Heated Humidified Nasal Cannula (AIRVOTM) in Hospital and at Home - An Open-Label, Non-Randomized Pilot Study.
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Heated humidified high-flow
Heated Humidified High-flow Nasal Cannula
Device: Heated Humidified High-flow Nasal Cannula
Patients will receive heated high humidity air through the AIRVO(TM) device starting in hospital and continuing for 60 days after hospital discharge. Oxygen will be titrated to target SpO2 between 88-92%, patients not requiring oxygen will receive heated high humidity air without oxygen. Temperature and flow rate will titrated to patient comfort with a target temperature 37 degree Celsius and flow rate of ≥20 l/minute. Patients will be encouraged to use the device overnight and when needed during the day with a target duration of at least 6 hours per night




Primary Outcome Measures :
  1. ER use or hospitalization for COPD [ Time Frame: Length of study participation (60 days after hospital discharge) ]
    ER visits or hospital admissions for COPD during the 60 day treatment period


Secondary Outcome Measures :
  1. Hospital length of stay [ Time Frame: Collected throughout inpatient enrollment period until last enrolled patient discharged (Expected total of 70 days) ]
    Total length of stay in hospital during index admission for COPD

  2. Use of home-care resources [ Time Frame: Length of study participation (60 days after hospital discharge) ]
    Total number of unplanned home visits during study period


Other Outcome Measures:
  1. Average daily use of heated humidified high-flow nasal cannula [ Time Frame: Length of study participation (60 days after hospital discharge) ]
    number of hours of machine use divided by days enrolled in study

  2. Number of eligible patients who consent to the trial [ Time Frame: Collected throughout inpatient enrollment period (total of 60 days) ]
    Proportion of eligible patients who consent will be calculated

  3. Drop out rate [ Time Frame: Length of study participation (60 days after hospital discharge) ]
    Proportion of patients who enroll in the trial who successfully complete the trial

  4. Patient satisfaction with heated humidified high-flow nasal cannula [ Time Frame: Collected at end of study participartion (60 days after hospital discharge) ]
    brief survey created for the study to measure patient satisfaction with the device. 5 questions, each individual item will be rated on a 5 part Likert scale from 1 = strongly agree to 5 = strongly disagree with a 1 indicating the highest satisfaction and a 5 indicating the lowest satisfaction. Results for each question will be reported separately.

  5. Nursing satisfaction with heated humidified high-flow nasal cannula in hospital [ Time Frame: Collected throughout inpatient enrollment period (total of 60 days) ]
    Anonymous satisfaction survey given to nurses on medical units, brief survey created for the study to measure nursing satisfaction with the device. 5 questions, each individual item will be rated on a 5 part Likert scale from 1 = strongly agree to 5 = strongly disagree with a 1 indicating the highest satisfaction and a 5 indicating the lowest satisfaction. Results for each question will be reported separately.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to Hospital with a primary diagnosis of exacerbation of COPD
  • Greater then or equal to 20 pack year history of smoking
  • Participating in Integrated Comprehensive Care (ICC) home care program

Exclusion Criteria:

  • Requirement for acute non-invasive ventilation in hospital
  • Use of nocturnal non-invasive ventilation prior to hospitalization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772626


Contacts
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Contact: Joshua Wald, MD 905-522-1155 ext 37036 waldj3@mcmaster.ca

Locations
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Canada, Ontario
St. Joseph's Healthcare Hamilton Recruiting
Hamilton, Ontario, Canada, L8N 4A6
Contact: Joshua Wald, MD    905-522-1155 ext 37036    waldj3@mcmaster.ca   
Contact: Terence Ho, MD    905-522-1155 ext 35873    terence.ho@medportal.ca   
Sponsors and Collaborators
McMaster University
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Joshua Wald, MD McMaster University
Publications:

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Responsible Party: Joshua Wald, Assistant Professor Department of Medicine, McMaster University
ClinicalTrials.gov Identifier: NCT03772626    
Other Study ID Numbers: Heated Humidity after COPDE
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Joshua Wald, McMaster University:
COPD
Heated humidified high-flow nasal cannula
Exacerbation of COPD
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases