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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Hypercapnic Respiratory Failure; Health-related Quality of Life; Obesity Hypoventilation Syndrome (OHS); Nasal High Flow
• Intervention / Treatment: Device: Nasal High Flow

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London
    • Hampstead, London, United Kingdom, NW3 2QG
      • Royal Free Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nasal High Flow; 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.	Device: Nasal High Flow; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Twelve weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Twelve weeks
Tolerability of Nasal High Flow	Assessing tolerability of nasal high flow use.	Twelve weeks
Acceptability of Nasal High Flow	Assessing the overall experience of using nasal high flow at home.	Twelve weeks

Collaborators and Investigators

• Sponsor: Royal Free Hospital NHS Foundation Trust
• Collaborators: Fisher and Paykel Healthcare; Royal Free Charity
• Investigators: Study Chair: Swapna Mandal, MBBS,PhD, Chief Investigator

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Estimated): January 26, 2024
• Study Completion (Estimated): January 26, 2024

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: December 7, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Disease Attributes; Overnutrition; Nutrition Disorders; Overweight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Obesity; Sleep Apnea, Obstructive; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Insufficiency; Hypoventilation; Obesity Hypoventilation Syndrome; Hypercapnia
• Other Study ID Numbers: 307348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All study data will be disseminated at the end of the study through appropriate publication and conference abstracts.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No