Chronic Hypercapnic Respiratory FailureNCT05167201
Domiciliary Nasal High Flow and Patient Outcomes in Chronic Hypercapnic Respiratory Failure in the United Kingdom
A study testing Nasal High Flow in people with Chronic Hypercapnic Respiratory Failure and Chronic Obstructive Pulmonary Disease, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome (OHS)
- What is being tested?
- Nasal High Flow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Mar 2022to 26 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 17Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome (OHS), Nasal High Flow, Health-related Quality of Life
- Being tested
- Nasal High Flow
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal High FlowDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Nasal High Flow | Experimental | 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. Receives: Device: Nasal High Flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Twelve weeks
Secondary outcomes (7)
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.
Measured: Twelve weeks
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.
Measured: Twelve weeks
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.
Measured: Twelve weeks
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.
Measured: Twelve weeks
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.
Measured: Twelve weeks
Tolerability of Nasal High Flow
Assessing tolerability of nasal high flow use.
Measured: Twelve weeks
Acceptability of Nasal High Flow
Assessing the overall experience of using nasal high flow at home.
Measured: Twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start28 Mar 2022
- Primary completion26 Jan 2024 (estimated)
- Study completion26 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pre and post intervention study
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Free Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare, Royal Free Charity
- Responsible party
- Sponsor
- Investigators
- Swapna Mandal, MBBS,PhD, Study chair, Chief Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167201
- Sponsor's protocol ID
- 307348
- Status last verified
- Dec 2023
- First submitted
- 1 Nov 2021
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All study data will be disseminated at the end of the study through appropriate publication and conference abstracts.
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05167201
- Acronym / sponsor ID
- 307348
- Conditions
- Chronic Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome (OHS), Nasal High Flow, Health-related Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Royal Free Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare, Royal Free Charity
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 26 Jan 2024 (estimated)
- Study completion
- 26 Jan 2024 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pre and post intervention study
| Arm | Type | Receives |
|---|---|---|
| Nasal High Flow | Experimental | Device: Nasal High FlowThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- All patients with chronic obstructive pulmonary disease (COPD) who meet these criteria for domiciliary NIV:
- 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
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal High FlowHigh 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. | Device | Nasal High Flow |
Primary outcome
Health-Related Quality of Life (HRQOL) measured by the Severe Respiratory Insufficiency Questionnaire (SRI)
Time frame: Twelve weeks
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.
7 secondary outcomes
Self-reported breathlessness measured by the Modified Borg Dyspnoea Scale (MBD scale)
Time frame: Twelve weeks
Excessive Daytime Sleepiness measured by the Epworth Sleepiness Score (ESS)
Time frame: Twelve weeks
Mean overnight arterial oxygenation (PaO2)
Time frame: Twelve weeks
Mean overnight transcutaneous carbon dioxide monitoring (PaCO2)
Time frame: Twelve weeks
Health Care Utilisation Questionnaire
Time frame: Twelve weeks
Tolerability of Nasal High Flow
Time frame: Twelve weeks
Acceptability of Nasal High Flow
Time frame: Twelve weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No. All study data will be disseminated at the end of the study through appropriate publication and conference abstracts.
Related trials for Chronic Hypercapnic Respiratory Failure
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Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
RecruitingObservational study
RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
Pulmonary Disease, Chronic Obstructive (COPD), Chronic Respiratory Failure With Hypercapnia
Recruiting
HFNC Versus NIV in Hypercapneic COPD Patients
COPD (Chronic Obstructive Pulmonary Disease)
Not yet recruiting
Extracorporeal Carbon Dioxide Removal Plus Noninvasive Ventilation in Patients With COPD Not Eligible for Intubation
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Recruiting
Nasal High Flow Versus Non-invasive Ventilation for Early Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Hypercapnic Acidosis
Acute Exacerbation of Chronic Obstructive Pulmonary Disease, Hypercapnic Acidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swapna Mandal, MBBS,PhD study chair
Chief Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal High Flow in people with Chronic Hypercapnic Respiratory Failure and Chronic Obstructive Pulmonary Disease, run by Royal Free Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (HRQOL) measured by the Severe Respiratory Insufficiency Questionnaire (SRI) (time frame: Twelve weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.