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Domiciliary Nasal High Flow and Patient Outcomes in Chronic Hypercapnic Respiratory Failure in the United Kingdom

Primary Purpose

Chronic Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome (OHS)

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Nasal High Flow
Sponsored by
Royal Free Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hypercapnic Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All patients with chronic obstructive pulmonary disease (COPD) who meet these criteria for domiciliary NIV:

    - Diagnosis of COPD based on spirometry; The ration of the forced expiratory volume in the first one second (FEV1) to the forced vital capacity (FVC) of the lungs (FEV1/FVC ratio), of ⩽ 0.70

    And either of:

    • i) Recent inpatient admission with acute hypercapnic respiratory failure with persistent hypercapnia (pH ≥ 7.35 and PaCO2 ≥ 6 kilopascal (kPa)) 2-4 weeks after the acute episode or
    • ii) COPD with evidence nocturnal hypoventilation (sleep study demonstrating time under 90% saturations for 30% of the sleep time) or
    • iii) Stable CHRF (paO2 ⩽ 8 kPa and paCO2 ≥ 6 kPa)

    OR

  2. All patients with OHS who meet these criteria for domiciliary NIV i) Diagnosis of OHS based on Body Mass Index > 30 kg/m2, daytime hypercapnia (PaCO2 ≥ 6kPa) and significant nocturnal hypoventilation (saturations ⩽ 90% for 30% of the total sleep time) or ii) Inpatient admission with acute hypercapnic respiratory failure requiring NIV referred for consideration of domiciliary treatment

who have been offered treatment with NIV and have:

3)

  • discontinued or demonstrated poor compliance with domiciliary NIV (defined as ⩽ 4 hours usage for 70% of the nights at 4 months with all reasonable measures taken to address barriers to treatment use)
  • evidence of sleep disordered breathing on a sleep study
  • over or equal to 18 years of age
  • able to provide informed consent
  • able to participate for the duration of the study
  • have an expected survival for greater than three months

All patients must meet inclusion criteria for 1 or 2 and all of 3

Exclusion Criteria:

  • Unstable psychiatric disease
  • Unable to return for review appointments e.g due to move home or lives a long distance from the study site
  • Pregnancy
  • Receiving home NIV treatment at time of inclusion to study
  • Receiving home NIV treatment for other medical illnesses, for example neuromuscular disease
  • Unable to read English

Sites / Locations

  • Royal Free HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nasal High Flow

Arm Description

The Nasal High Flow device is an integrated flow generator that delivers warmed and humidified air to spontaneously breathing patients through a variety of patient interfaces. Flow rates up to 60 litres/minute are available to the user, depending on the patient interface and mode of operation.

Outcomes

Primary Outcome Measures

Health-Related Quality of Life (HRQOL) measured by the Severe Respiratory Insufficiency Questionnaire (SRI)
SRI is a validated tool to assess HRQOL in patients with chronic respiratory failure receiving home mechanical ventilation, and has been shown to be applicable to different respiratory diseases. It consists of eight subscales measuring different aspects of health status with lower scores (0 to 100) indicating poorer health or higher disability.

Secondary Outcome Measures

Self-reported breathlessness measured by the Modified Borg Dyspnoea Scale (MBD scale)
The Modified Borg Dyspnoea scale measures the perceived rate of difficulty of breathing on a 0 to 10 rated numerical score, which can be used during submaximal exercise in addition. A higher score indicates higher perceived breathlessness and the aim is to compare this from baseline to the end of the study.
Excessive Daytime Sleepiness measured by the Epworth Sleepiness Score (ESS)
The ESS is a self-administered questionnaire with 8 questions and respondents are asked to rate, on a 4 point scale (0-3), their usual chances of dosing off or falling asleep. The ESS score can range from 0 to 24 and the higher the score, the higher that person's average sleep propensity in daily life or their 'daytime sleepiness'. The aim is to compare this from baseline to the end of the study.
Mean overnight arterial oxygenation (PaO2)
The aim to is to evaluate the efficacy of NHF regarding overnight arterial oxygenation and all participants will have overnight oximetry performed twice on nasal high flow during the study, which will be compared to their baseline off treatment.
Mean overnight transcutaneous carbon dioxide monitoring (PaCO2)
The aim is to evaluate the efficacy of NHF regarding overnight arterial carbon dioxide monitoring and all participants will have overnight carbon dioxide monitoring performed twice on nasal high flow during the study which will be compared to their baseline off treatment.
Health Care Utilisation Questionnaire
We will collect health resource usage by a health utilisation questionnaire based on the 10 core items of Standardised Resource Use Measure to capture core items of health resource use. from hospital admissions, to general practice and community settings, as well as home visits and medications. This will allow us to present simple cost consequence data of nasal high flow and to review how it compares from baseline to the end of the study.
Tolerability of Nasal High Flow
Assessing tolerability of nasal high flow use.
Acceptability of Nasal High Flow
Assessing the overall experience of using nasal high flow at home.

Full Information

First Posted
November 1, 2021
Last Updated
November 11, 2022
Sponsor
Royal Free Hospital NHS Foundation Trust
Collaborators
Fisher and Paykel Healthcare, Royal Free Charity
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1. Study Identification

Unique Protocol Identification Number
NCT05167201
Brief Title
Domiciliary Nasal High Flow and Patient Outcomes in Chronic Hypercapnic Respiratory Failure in the United Kingdom
Official Title
Does Domiciliary Nasal High Flow (NHF) Therapy Improve Patient Outcomes in Chronic Hypercapnic Respiratory Failure (CHRF) in the United Kingdom (UK): A Pre and Post Interventional Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Free Hospital NHS Foundation Trust
Collaborators
Fisher and Paykel Healthcare, Royal Free Charity

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic hypercapnic respiratory failure (CHRF) in the context of Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS) is associated with increased mortality. The availability and effectiveness of domiciliary Non-invasive ventilation (NIV) treatment (when indicated) is key as this treatment can improve quality of life and reduce health-care costs from associated burden of disease. The emerging obesity epidemic means that there is now increased home mechanical ventilation set-ups in patients with obesity related respiratory failure (ORRF), yet there are no alternative treatments for patients struggling with domiciliary NIV. Domiciliary NHF has been shown to improve health related quality of life in stable CHRF in patients with COPD and improve cost effectiveness yet there are no current studies looking at the use of domiciliary NHF and its outcomes in ORRF. The study aims to deliver a pre and post intervention study evaluating patient reported and clinical outcomes in patients using NHF over twelve weeks, who have either COPD or OHS and have been unable to use domiciliary NIV. The study wishes to address key outcomes such as quality of life, clinical effectiveness, compliance and acceptability with the use of domiciliary NHF in both of these patient populations.
Detailed Description
This study is an investigator-initiated, unblinded, multi-centre, one arm pre and post interventional study evaluating the use of nasal high flow over twelve weeks, upon self-reported quality of life in adults aged 18 and above, with COPD or OHS and CHRF. This is not a comparator trial and will provide preliminary information on the intervention in a group of individuals who cannot comply with current guideline recommended therapy (with all strategies used to address any barriers to current treatment usage). This study will therefore aim to evaluate if this treatment offers effective outcomes in this difficult to treat population thus reflecting the variations in practice and choices that occur for this group of individuals in real practice. Ethical approval will be obtained from the research ethical committee of Brighton and Sussex. Informed consent will be obtained from all willing participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome (OHS), Nasal High Flow, Health-related Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm pre and post intervention study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nasal High Flow
Arm Type
Experimental
Arm Description
The Nasal High Flow device is an integrated flow generator that delivers warmed and humidified air to spontaneously breathing patients through a variety of patient interfaces. Flow rates up to 60 litres/minute are available to the user, depending on the patient interface and mode of operation.
Intervention Type
Device
Intervention Name(s)
Nasal High Flow
Intervention Description
High flow nasal cannula (NHF) is a device that delivers warmed and humid air through a high air flow rate, through the nose. It is used as a non-invasive ventilatory approach, which is relatively comfortable, in the management of respiratory failure and has been investigated in several studies evaluating the outcomes as domiciliary treatment in patients with COPD.
Primary Outcome Measure Information:
Title
Health-Related Quality of Life (HRQOL) measured by the Severe Respiratory Insufficiency Questionnaire (SRI)
Description
SRI is a validated tool to assess HRQOL in patients with chronic respiratory failure receiving home mechanical ventilation, and has been shown to be applicable to different respiratory diseases. It consists of eight subscales measuring different aspects of health status with lower scores (0 to 100) indicating poorer health or higher disability.
Time Frame
Twelve weeks
Secondary Outcome Measure Information:
Title
Self-reported breathlessness measured by the Modified Borg Dyspnoea Scale (MBD scale)
Description
The Modified Borg Dyspnoea scale measures the perceived rate of difficulty of breathing on a 0 to 10 rated numerical score, which can be used during submaximal exercise in addition. A higher score indicates higher perceived breathlessness and the aim is to compare this from baseline to the end of the study.
Time Frame
Twelve weeks
Title
Excessive Daytime Sleepiness measured by the Epworth Sleepiness Score (ESS)
Description
The ESS is a self-administered questionnaire with 8 questions and respondents are asked to rate, on a 4 point scale (0-3), their usual chances of dosing off or falling asleep. The ESS score can range from 0 to 24 and the higher the score, the higher that person's average sleep propensity in daily life or their 'daytime sleepiness'. The aim is to compare this from baseline to the end of the study.
Time Frame
Twelve weeks
Title
Mean overnight arterial oxygenation (PaO2)
Description
The aim to is to evaluate the efficacy of NHF regarding overnight arterial oxygenation and all participants will have overnight oximetry performed twice on nasal high flow during the study, which will be compared to their baseline off treatment.
Time Frame
Twelve weeks
Title
Mean overnight transcutaneous carbon dioxide monitoring (PaCO2)
Description
The aim is to evaluate the efficacy of NHF regarding overnight arterial carbon dioxide monitoring and all participants will have overnight carbon dioxide monitoring performed twice on nasal high flow during the study which will be compared to their baseline off treatment.
Time Frame
Twelve weeks
Title
Health Care Utilisation Questionnaire
Description
We will collect health resource usage by a health utilisation questionnaire based on the 10 core items of Standardised Resource Use Measure to capture core items of health resource use. from hospital admissions, to general practice and community settings, as well as home visits and medications. This will allow us to present simple cost consequence data of nasal high flow and to review how it compares from baseline to the end of the study.
Time Frame
Twelve weeks
Title
Tolerability of Nasal High Flow
Description
Assessing tolerability of nasal high flow use.
Time Frame
Twelve weeks
Title
Acceptability of Nasal High Flow
Description
Assessing the overall experience of using nasal high flow at home.
Time Frame
Twelve weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with chronic obstructive pulmonary disease (COPD) who meet these criteria for domiciliary NIV: - Diagnosis of COPD based on spirometry; The ration of the forced expiratory volume in the first one second (FEV1) to the forced vital capacity (FVC) of the lungs (FEV1/FVC ratio), of ⩽ 0.70 And either of: i) Recent inpatient admission with acute hypercapnic respiratory failure with persistent hypercapnia (pH ≥ 7.35 and PaCO2 ≥ 6 kilopascal (kPa)) 2-4 weeks after the acute episode or ii) COPD with evidence nocturnal hypoventilation (sleep study demonstrating time under 90% saturations for 30% of the sleep time) or iii) Stable CHRF (paO2 ⩽ 8 kPa and paCO2 ≥ 6 kPa) OR All patients with OHS who meet these criteria for domiciliary NIV i) Diagnosis of OHS based on Body Mass Index > 30 kg/m2, daytime hypercapnia (PaCO2 ≥ 6kPa) and significant nocturnal hypoventilation (saturations ⩽ 90% for 30% of the total sleep time) or ii) Inpatient admission with acute hypercapnic respiratory failure requiring NIV referred for consideration of domiciliary treatment who have been offered treatment with NIV and have: 3) discontinued or demonstrated poor compliance with domiciliary NIV (defined as ⩽ 4 hours usage for 70% of the nights at 4 months with all reasonable measures taken to address barriers to treatment use) evidence of sleep disordered breathing on a sleep study over or equal to 18 years of age able to provide informed consent able to participate for the duration of the study have an expected survival for greater than three months All patients must meet inclusion criteria for 1 or 2 and all of 3 Exclusion Criteria: Unstable psychiatric disease Unable to return for review appointments e.g due to move home or lives a long distance from the study site Pregnancy Receiving home NIV treatment at time of inclusion to study Receiving home NIV treatment for other medical illnesses, for example neuromuscular disease Unable to read English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anita Saigal, BM,BSc,MRCP
Phone
02077940500
Email
anita.saigal@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swapna Mandal, MBBS,PhD
Organizational Affiliation
Chief Investigator
Official's Role
Study Chair
Facility Information:
Facility Name
Royal Free Hospital
City
Hampstead
State/Province
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Saigal, BM,BSc,MRCP
Phone
02077940500
Email
anita.saigal@nhs.net

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
All study data will be disseminated at the end of the study through appropriate publication and conference abstracts.

Learn more about this trial

Domiciliary Nasal High Flow and Patient Outcomes in Chronic Hypercapnic Respiratory Failure in the United Kingdom

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