Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

NCT ID: NCT05756387

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-01

Study Completion Date

2028-12-01

Brief Summary

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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

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

Conditions

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Chronic Respiratory Failure Non-invasive Ventilation

Keywords

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Monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD patients with Chronic Respiratory Failure

Non-invasive ventilation

Intervention Type DEVICE

NIV as in standard care

Interventions

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Non-invasive ventilation

NIV as in standard care

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Twente

OTHER

Sponsor Role collaborator

Löwenstein BV

UNKNOWN

Sponsor Role collaborator

Vivisol

OTHER

Sponsor Role collaborator

Sencure BV

UNKNOWN

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marieke L Duiverman

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

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UMCG

Groningen, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Marieke L Duiverman, MD PhD

Role: CONTACT

Phone: 0031503613200

Email: [email protected]

Facility Contacts

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Marieke Duiverman, MD PhD

Role: primary

Other Identifiers

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16013

Identifier Type: -

Identifier Source: org_study_id