Status:
SUSPENDED
Efficacy of an Advanced Auto-titrating NIV in COPD
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Chronic Obstructive Pulmonary Disease Severe
Eligibility:
All Genders
18+ years
Phase:
NA
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 breathl...
Eligibility Criteria
Inclusion
- Patient
- 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
- 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
Key Trial Info
Start Date :
May 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04848012
Start Date
May 4 2021
End Date
January 1 2025
Last Update
April 3 2024
Active Locations (1)
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1
Guys and St Thomas NHS Foundation Trust
London, United Kingdom, SE1 7EH