Efficacy of an Advanced Auto-titrating NIV in COPD

NCT04848012 | Suspended

• 1 other identifier: 279564
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease Severe

Outcome Measures

Primary Outcomes (1)

• Adherence to ventilation therapy

  Number of hours spent on nocturnal ventilation therapy

  6 weeks

Secondary Outcomes (11)

• Mean nocturnal transcutaneous carbon dioxide level

  1 night during single night admission

• Maximal nocturnal transcutaneous carbon dioxide level

  1 night during single night admission

• Sleep parameters

  1 night during single night admission

• Sleep parameters

  1 night during single night admission

• Sleep parameters

  1 night during single night admission

Study Arms (2)

Usual non-invasive ventilation

NO INTERVENTION

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

Auto-titrating non-invasive ventilation

EXPERIMENTAL

A novel auto-titrating non-invasive ventilator

Device: Auto-titrating non-invasive ventilation

Interventions

Auto-titrating non-invasive ventilation 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.

Auto-titrating non-invasive ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys and St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Study Officials

• Neeraj Shah

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Nicholas Hart

  Guy's and St Thomas' NHS Foundation Trust

  STUDY CHAIR

• Patrick Murphy

  Guy's and St Thomas' NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: April 19, 2021
• Study Start: May 4, 2021
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)