Heated High Humidity After COPD Exacerbation

April 6, 2022 updated by: Joshua Wald, McMaster University

The Feasibility and Efficacy of Heated Humidified Nasal Cannula (AIRVOTM) in Hospital and at Home - An Open-Label, Non-Randomized Pilot Study.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

COPD is a respiratory condition that is often associated with cigarette smoking, and defined by incompletely reversible airflow obstruction and complicated by exacerbations. Mucous hypersecretion with impaired mucociliary transport are frequently present, and are associated with infective AECOPD, and death related to pulmonary infection. COPD is both common, affecting 1 in 6 Canadians, and burdensome, being the 4th leading cause of death, in the Canadian population.

In Canada, the most common primary diagnosis associated with admission to hospital is acute exacerbation of COPD (AECOPD). For moderate to severe COPD, the average patient will have more than 2 AECOPD per year. A single episode conveys a poor prognosis, being associated with death, further AECOPD events, and reduced health-related quality of life. Despite multiple guideline-based management strategies, 1 in 3 patients with AECOPD will have another episode within 8 weeks.

Although the technology for heated humidified high-flow nasal cannula (HFNC) has been available for two decades, it has only recently become widely available for adults. The rapid humidification of gas allows this system to achieve flow rates of up to 60 liters per minute. These two factors, in combination, allow for a higher achieved fraction of inspired oxygen, and benefit the expectoration of secretions and ventilatory efficiency. Randomised clinical trials of ICU patients have demonstrated that HFNC is non-inferior to non-invasive ventilation both in the setting of acute hypoxemic respiratory failure and as an adjunct therapy post-extubation.

HFNC is a promising treatment for patients with COPD as it can counteract potentially harmful mucous abnormalities by reducing mucous viscosity and restoring mucociliary transport. Randomised studies have also demonstrated that HFNC administered at home results in an increased the time to first exacerbation, fewer AECOPD, improved quality-of-life, and reduced PaCO2. However, the efficacy of HFNC during hospital admission, when mucous abnormalities and poor expectoration could be most pronounced, has not yet been studied. Furthermore, the feasibility and efficacy of this device as a patient transitions from the hospital to the community after an AECOPD remains to be elucidated.

The objectives of this study are to test the efficacy of a heated humidified high-flow nasal cannula used during and after a hospital admission for AECOPD to reduce the risk of return to ER or readmission, and the feasibility of implementing such a device starting in hospital with transition to the home environment.

This is an open-label, non-randomized pilot study of in-hospital and home HFNC in patients with COPD. Patients who consent to participate will have an a heated humidified high-flow nasal cannula device configured by a respiratory therapist and available at their bedside in hospital. Fraction of inspired oxygen will be adjusted as needed to obtain a pulse oximetry reading between 88-92%. If hypoxemia is not present (peripheral oxygen saturation (SpO2) ≥88%) on room air, then the device will be used without supplemental oxygen. Temperature and flow rate will be titrated for patient comfort with a target temperature of 37 degrees Celsius and flow rate of ≥20 liters per minute if tolerated. Participants will be instructed to use the device overnight and as much as they like during the day targeting at least 6 hours of use per 24 hour period.

At discharge, subjects will be provided with a heated humidified high-flow nasal cannula home device. Targeted use and oxygen titration will remain unchanged from inpatient use. A respiratory therapist from will perform a home visit within 24 hours of hospital discharge to educate the patient on home use and ensure proper set up of the device, and an additional visit 2 weeks post-discharge. Patients will have access to a 24 hour emergency telephone number if they have any concerns. The duration of the trial will be 60 days post-discharge after which the device will be returned.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
        • St. Joseph's Healthcare Hamilton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Length of study participation (60 days after hospital discharge)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Collected throughout inpatient enrollment period until last enrolled patient discharged (Expected total of 70 days)
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
Length of study participation (60 days after hospital discharge)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Length of study participation (60 days after hospital discharge)
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
Collected throughout inpatient enrollment period (total of 60 days)
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
Length of study participation (60 days after hospital discharge)
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.
Collected at end of study participartion (60 days after hospital discharge)
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.
Collected throughout inpatient enrollment period (total of 60 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Joshua Wald, MD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 6, 2018

First Submitted That Met QC Criteria

December 10, 2018

First Posted (Actual)

December 11, 2018

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Heated Humidity after COPDE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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