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Recruiting NCT05756387

Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

— Observational Chronic Respiratory Failure Non-invasive Ventilation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-invasive ventilation.
Who it may be relevant to
Registry conditions: Chronic Respiratory Failure, Non-invasive Ventilation. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Device Non-invasive ventilation
    NIV as in standard care

Primary outcome measures

  • Gas exchange [Time frame: baseline]
  • Gas exchange [Time frame: 2 months]
  • Gas exchange [Time frame: 4 months]
  • Gas exchange [Time frame: 6 months]
  • Patient comfort [Time frame: baseline]
  • Patient comfort [Time frame: 2 months]
  • Patient comfort [Time frame: 4 months]
  • Patient comfort [Time frame: 6 months]
  • AECOPD [Time frame: 2 months, 4 months, 6 months]
  • AECOPD [Time frame: 2 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • UMCG — Groningen

Identifiers

NCT: NCT05756387 · 16013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗