Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339580
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-03-25
Brief Title:
Assessment of Volume-targeted Ventilation in Patients With Neuromuscular Disease
Sponsor:
Guys and St Thomas NHS Foundation Trust
Organization:
Guys and St Thomas NHS Foundation Trust
Study Overview
Official Title:
A Proof-on-concept Study to Investigate the Potential Use of Volume-targeted Ventilation in Patients With Slowly Progressive Neuromuscular Disease
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VT-NMD
Brief Summary:
Assessment of safety and efficacy of volume-targeted ventilation in patients with neuromuscular disease
Detailed Description:
Patients with neuromuscular diseases NMD can suffer from breathing difficulties requiring treatment with a breathing device known as non-invasive ventilation NIV NIV aims to support the lungs in removing the waste gas carbon dioxide CO2 This is important because patients with high CO2 levels tend to have worse clinical outcomes
NIV delivers different pressures to the airway when the patient breathes in and when they breathe out Usually the pressures it delivers are fixed ie they do not change breath-to-breath Newer technology allows the machine to independently change the pressures depending on various patient factors it can measure There are a small number of studies that suggested that these auto-titrating machines may improve control of carbon dioxide but further work is needed One of these modes allows us to set a target volume that should be delivered to the patient each breath and the machine changes settings to deliver this target volume in response to changing patient parameters We aim to investigate the safety and efficacy of this volume-targeted NIV VT-NIV in order to generate data to design a randomised controlled trial to compare VT-NIV with fixed-NIV
Patients with NMD who use fixed-NIV will be admitted for a two-night stay to our centre On the first night their CO2 control will be assessed on their current ventilator On the second night they will be switched to the VT-NIV mode They will be discharged and asked to use the new mode for three months Individuals with well-controlled CO2 with their usual mode will allow us to assess the safety of VT-NIV and individuals with poorly-controlled CO2 will allow us to assess its efficacy At three months they will attend an outpatient visit where use of the new mode will be assessed through data download from the machine and completion of questionnaires
NIV delivers different pressures to the airway when the patient breathes in and when they breathe out Usually the pressures it delivers are fixed ie they do not change breath-to-breath Newer technology allows the machine to independently change the pressures depending on various patient factors it can measure There are a small number of studies that suggested that these auto-titrating machines may improve control of carbon dioxide but further work is needed One of these modes allows us to set a target volume that should be delivered to the patient each breath and the machine changes settings to deliver this target volume in response to changing patient parameters We aim to investigate the safety and efficacy of this volume-targeted NIV VT-NIV in order to generate data to design a randomised controlled trial to compare VT-NIV with fixed-NIV
Patients with NMD who use fixed-NIV will be admitted for a two-night stay to our centre On the first night their CO2 control will be assessed on their current ventilator On the second night they will be switched to the VT-NIV mode They will be discharged and asked to use the new mode for three months Individuals with well-controlled CO2 with their usual mode will allow us to assess the safety of VT-NIV and individuals with poorly-controlled CO2 will allow us to assess its efficacy At three months they will attend an outpatient visit where use of the new mode will be assessed through data download from the machine and completion of questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None