Status:

UNKNOWN

Volume Mode Non-invasive Ventilation in Amyotrophic Lateral Sclerosis

Lead Sponsor:

University Hospitals Coventry and Warwickshire NHS Trust

Conditions:

Amyotrophic Lateral Sclerosis

Respiratory Failure

Eligibility:

All Genders

18-100 years

Phase:

NA

Brief Summary

The purpose of this study is to assess the efficacy of using intelligent volume assured pressure support (iVAPS-AE) versus spontaneous timed (ST) modes of non-invasive ventilation (NIV) in patients di...

Detailed Description

Amyotrophic lateral sclerosis (ALS) is one of five motor neurone diseases (MNDs). It is a rare, incurable disease characterised by progressive destruction of nerve cells called motor neurones that ins...

Eligibility Criteria

Inclusion

  • Patients with respiratory failure secondary to ALS (diagnosed either at an MND MDT or specialist neurology clinic) according to criteria set out in the NICE guideline (NG42) (2016); Motor neurone disease: assessment and management.
  • Patients able to provide informed consent to take part in the research study.
  • Patients not contraindicated to commence NIV in accordance with local protocol.
  • Patients not currently enrolled in another research study that could alter disease progression.

Exclusion

  • Acutely unwell or medically complicated patients as assessed by lead investigator. These patients will be urgently reviewed by a dedicated Consultant Physician. The Principal Investigator will be immediately informed.
  • An inability to provide informed consent.
  • An inability to use NIV.
  • Patients whom are contraindicated to commence NIV in accordance with local protocol.

Key Trial Info

Start Date :

March 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 15 2024

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT05328492

Start Date

March 15 2022

End Date

March 15 2024

Last Update

June 1 2023

Active Locations (1)

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1

University Hospital Coventry and Warwickshire NHS Trust

Coventry, West Midlands, United Kingdom, CV2 2DX