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

NCT ID: NCT05167201

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2024-01-26

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.

Conditions

Chronic Hypercapnic Respiratory Failure; Chronic Obstructive Pulmonary Disease; Obesity Hypoventilation Syndrome (OHS); Nasal High Flow; Health-related Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nasal High Flow

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: collaborator

Royal Free Charity

UNKNOWN

Sponsor Role: collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Swapna Mandal, MBBS,PhD

Role: STUDY_CHAIR

Chief Investigator

Locations

Royal Free Hospital

Hampstead, London, United Kingdom

Countries

United Kingdom

Other Identifiers

307348

Identifier Type: -

Identifier Source: org_study_id