RecruitingPhase 2NCT06339580

Assessment of Volume-targeted Ventilation in Patients With Neuromuscular Disease

A Proof-on-concept Study to Investigate the Potential Use of Volume-targeted Ventilation in Patients With Slowly Progressive Neuromuscular Disease

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrollment

30 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

Neuromuscular Diseases

Summary

Assessment of safety and efficacy of volume-targeted ventilation in patients with neuromuscular disease.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

Slowly progressive neuromuscular disease
Established on fixed bi-level ventilation
Documented clinical respiratory stability by supervising clinician (no hospitalizations, respiratory infections or change to ventilator settings in preceding 6 weeks)

Exclusion Criteria6

Rapidly progressive neuromuscular disease
Decompensated respiratory failure (pH < 7.35)
Pregnancy
Aged <18, >80
Poor adherence to NIV (<4hrs per night)
Significant physical or psychiatric co-morbidity that would prevent compliance with trial protocol

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Interventions

DEVICEVolume-targeted non-invasive ventilation

A target tidal volume is set on the ventilation device, and the device will then automatically adjust delivered pressures to reach this target tidal volume.