NCT05167201

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Royal Free Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-28
• Primary completion: 2024-01-26
• Completion: 2024-01-26
• First posted: 2021-12-22
• Last updated: 2023-12-14

Locations

1 site across 1 country: United Kingdom