Efficacy of an Advanced Auto-titrating NIV in COPD

Chronic Obstructive Pulmonary Disease Severe Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04848012
• Other study ID #: 279564
• Status: Suspended
• Phase: N/A
• Start date: May 4, 2021
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 28
• Est. completion date: January 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Severe
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Guys and St Thomas NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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