Efficacy of an Advanced Auto-titrating NIV in COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-04

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease Severe

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

12 weeks sequential (pre/post) study. Participants will receive usual NIV treatment for 6 weeks followed by novel ventilator for 6 weeks.

There will be a randomised crossover element for one night at the midpoint of the study to assess sleep parameters on the two ventilation modalities.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Usual non-invasive ventilation

The usual therapy the participant is receiving via non-invasive ventilator.

Group Type NO_INTERVENTION

No interventions assigned to this group

Auto-titrating non-invasive ventilation

A novel auto-titrating non-invasive ventilator

Group Type EXPERIMENTAL

Auto-titrating non-invasive ventilation

Intervention Type DEVICE

A non-invasive ventilator designed to auto-adjust the expiratory positive airway pressure according to expiratory flow limitation, measured using the forced oscillation technique.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes