Heated High Humidity After COPD Exacerbation

NCT03772626 | Unknown

• 1 other identifier: Heated Humidity after COPDE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD Exacerbation

Keywords

COPD; Heated humidified high-flow nasal cannula; Exacerbation of COPD

Outcome Measures

Primary Outcomes (1)

• ER use or hospitalization for COPD

  ER visits or hospital admissions for COPD during the 60 day treatment period

  Length of study participation (60 days after hospital discharge)

Secondary Outcomes (2)

• Hospital length of stay

  Collected throughout inpatient enrollment period until last enrolled patient discharged (Expected total of 70 days)

• Use of home-care resources

  Length of study participation (60 days after hospital discharge)

Other Outcomes (5)

• Average daily use of heated humidified high-flow nasal cannula

  Length of study participation (60 days after hospital discharge)

• Number of eligible patients who consent to the trial

  Collected throughout inpatient enrollment period (total of 60 days)

• Drop out rate

  Length of study participation (60 days after hospital discharge)

Study Arms (1)

Heated humidified high-flow

EXPERIMENTAL

Heated Humidified High-flow Nasal Cannula

Device: Heated Humidified High-flow Nasal Cannula

Interventions

Heated Humidified High-flow Nasal Cannula DEVICE

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

Heated humidified high-flow

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (15)

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• Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joshua Wald, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Department of Medicine

Model Details: Single group non-randomized open label study of efficacy and feasibility. Comparison will be to historical controls.

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 11, 2018
• Study Start: February 25, 2019
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)