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

NCT05167201 | Unknown

• 1 other identifier: 307348
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Self-reported breathlessness measured by the Modified Borg Dyspnoea Scale (MBD scale)

  Twelve weeks

• Excessive Daytime Sleepiness measured by the Epworth Sleepiness Score (ESS)

  Twelve weeks

• Mean overnight arterial oxygenation (PaO2)

  Twelve weeks

• Mean overnight transcutaneous carbon dioxide monitoring (PaCO2)

  Twelve weeks

• Health Care Utilisation Questionnaire

  Twelve weeks

Study Arms (1)

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.

Device: Nasal High Flow

Interventions

Nasal High Flow 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.

Nasal High Flow

Eligibility Criteria

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

You may qualify if:

• 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)
• 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:
• 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

You may not qualify if:

• 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 for other medical illnesses, for example neuromuscular disease
• Unable to read English

Sponsors & Collaborators

• Royal Free Hospital NHS Foundation Trust: lead
• Fisher and Paykel Healthcare: collaborator
• Royal Free Charity: collaborator

Study Sites (1)

Royal Free Hospital

Hampstead, London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Swapna Mandal, MBBS,PhD

  Chief Investigator

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm pre and post intervention study

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: December 22, 2021
• Study Start: March 28, 2022
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)