Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

Recruiting

• Conditions: Chronic Respiratory Failure; Non-invasive Ventilation
• Interventions: Device: Non-invasive ventilation

• Registration Number: NCT05756387
• Lead Sponsor: University Medical Center Groningen

Brief Summary

The aim of the data collection is to create an advanced reliable method to remotely monitor patient on chronic home non-invasive ventilation (NIV), both regarding ventilatory efficacy and patient comfort, both in the hospital and at home by assessing gas exchange, lung mechanics and the interaction between the patient and the ventilator.

For this purpose, we will set-up of databank of synchronously acquired datasets of already standard care monitored parameters during NIV (transcutaneous monitoring of gas exchange; ventilator data including data on PVA), and newly non-invasively acquired data on patient effort (EMG, patient ratings) and lung (hyper)inflation (EIT), during the set-up and follow-up of standard care chronic NIV.

Detailed Description

Can be provided on request as the registry rules are no in Dutch

Study Timeline

• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-06
• Status Verified: 2024-12
• Study Start: 2024-12-01
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2028-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• COPD patients indicated for chronic home NIV

Exclusion Criteria

• not able to read the written information and/or sign the informed consent form
• no possibility to perfrom measurements at home

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD patients with Chronic Respiratory Failure	Non-invasive ventilation	-

Primary Outcome Measures

Name	Time	Method
Sleep quality	6 months	Sleep quality assessing sleep depth and sleep stages
Patient comfort	6 months	Patient comfort assessed by VAS scale
AECOPD	4 months	Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
Gas exchange	6 months	Transcutaneous monitoring of gas exchange
Hospitalisations for AECOPD	6 months	Hospitalisations for acute exacerbations of COPD

Trial Locations

Locations (1)

UMCG; 🇳🇱 Groningen, Netherlands