Efficacy of an Advanced Auto-titrating NIV in COPD

Clinical Validation, Safety & Efficacy Study of an Advanced Auto-titrating Non-invasive Ventilator in Patients With Severe Chronic Obstructive Pulmonary Disease

Patients with chronic obstructive pulmonary disease (COPD) can eventually progress to respiratory failure, where they cannot adequately exchange oxygen and carbon dioxide, leading to worsening breathlessness, frequent hospitalisations and death. Non-invasive ventilation (NIV) is a ventilator therapy that is used in COPD patients who suffer from respiratory failure. Studies have demonstrated that using NIV at night regularly can result in improved clinical outcomes.

Adherence to this therapy is variable, however. This can be due to poor synchrony between the device and the lungs. A novel ventilator has been designed that delivers NIV but is also incorporated with technology to assess for aberrations in respiratory physiology and correct them, breath-by-breath.

The investigators aim to assess the efficacy, safety and tolerability of this novel ventilator. The primary research question is whether the novel ventilator can improve adherence to therapy, when compared with the usual ventilator.

Patients with COPD who use ventilation at home will be screened for inclusion in the study. Participation will involve a screening visit, and a further two visits to the Lane Fox Respiratory Unit. The first will require a two-night admission and the second a single-night admission. They will undergo detailed assessment of their daytime and overnight respiratory and sleep physiology during these admissions. These visits will be separated by a six-week period during which they will be asked to use the novel ventilator at home.

Patients will be recruited into a sub-study to evaluate the performance of the ventilator in a daytime physiological assessment. This will involve detailed invasive physiological assessment of expiratory flow limitation and how the machine is able to adjust settings to optimise respiratory support.

Study Overview

• Status: Suspended
• Conditions: Chronic Obstructive Pulmonary Disease Severe
• Intervention / Treatment: Device: Auto-titrating non-invasive ventilation

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Guys and St Thomas NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Patient Inclusion Criteria:

• Age ≥ 18 years
• BMI <30 kg/m¬2
• Confirmed diagnosis of COPD
• Currently using domiciliary NIV with average reported compliance of at least 3hours
• Ability to provide informed consent
• Medical stability confirmed by recruiting physician
• Free of exacerbations for at least 2 weeks prior to enrolment
• Presence of expiratory flow limitation on forced oscillation technique criteria

Exclusion Criteria:

• Current acute illness as determined by recruiting physician e.g. upper respiratory tract infection
• Presence of major medical comorbidity, e.g. severe heart failure (LVEF <30%), active malignancy, end-stage renal failure (CKD 4), and neuromuscular disease
• Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
• Psychosocial factors that would prevent compliance with study protocol

Healthy participant inclusion criteria:

• Age ≥ 18 years
• No expiratory flow limitation on forced oscillation testing
• No acute illness on study day
• Ability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual non-invasive ventilation; The usual therapy the participant is receiving via non-invasive ventilator.
Experimental: Auto-titrating non-invasive ventilation; A novel auto-titrating non-invasive ventilator	Device: Auto-titrating non-invasive ventilation; A non-invasive ventilator designed to auto-adjust the expiratory positive airway pressure according to expiratory flow limitation, measured using the forced oscillation technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to ventilation therapy	Number of hours spent on nocturnal ventilation therapy	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean nocturnal transcutaneous carbon dioxide level	Mean nocturnal transcutaneous carbon dioxide level measured on single night admission	1 night during single night admission
Maximal nocturnal transcutaneous carbon dioxide level	Maximal nocturnal transcutaneous carbon dioxide level measured on single night admission	1 night during single night admission
Sleep parameters	Sleep efficiency, measured by polysomnography	1 night during single night admission
Sleep parameters	Wake after sleep onset, measured by polysomnography	1 night during single night admission
Sleep parameters	Time in rapid eye movement/non rapid eye movement sleep, measured by polysomnography	1 night during single night admission
Sleep parameters	Apnoea/hypopnoea index, measured by polysomnography	1 night during single night admission
Sleep parameters	4 per cent oxygen desaturation index, measured by polysomnography	1 night during single night admission
Inspiratory capacity	Inspiratory capacity following 6 weeks of each NIV device	6 weeks
Health-related quality of life	Measured using COPD Assessment Test	6 weeks
Health-related quality of life	Measured using Severe Respiratory Insufficiency Questionnaire	6 weeks
Daytime physical activity	Measured using wrist actigraphs during the final 2 weeks of each 6 week arm	2 weeks

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Principal Investigator: Neeraj Shah, Guy's and St Thomas' NHS Foundation Trust; Study Chair: Nicholas Hart, Guy's and St Thomas' NHS Foundation Trust; Study Director: Patrick Murphy, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: April 15, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 279564

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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