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Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05756387
Acronym
NOCTIVENT
Enrollment
100
Registered
2023-03-06
Start date
2024-12-01
Completion date
2028-12-01
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Respiratory Failure, Non-invasive Ventilation

Keywords

Monitoring

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

Interventions

DEVICENon-invasive ventilation

NIV as in standard care

Sponsors

University Medical Center Groningen
Lead SponsorOTHER
University of Twente
CollaboratorOTHER
Löwenstein BV
CollaboratorUNKNOWN
Vivisol
CollaboratorOTHER
Sencure BV
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Gas exchangebaselineTranscutaneous monitoring of gas exchange
Patient comfortbaselinePatient comfort assessed by VAS scale
AECOPD2 months, 4 months, 6 monthsAcute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
Hospitalisations for AECOPD6 monthsHospitalisations for acute exacerbations of COPD
Sleep quality2 monthsSleep quality assessing sleep depth and sleep stages

Countries

Netherlands

Contacts

CONTACTMarieke L Duiverman, MD PhD
m.l.duiverman@umcg.nl0031503613200
PRINCIPAL_INVESTIGATORMarieke L Duiverman

University Medical Center Groningen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026