NOCTIVENT: Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

Sponsor

University Medical Center Groningen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05756387

Collaborator

University of Twente (Other), Löwenstein BV (Other), Vivisol (Other), Sencure BV (Other)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Respiratory Failure Non-invasive Ventilation	Device: Non-invasive ventilation

Detailed Description

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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2028

Anticipated Study Completion Date :

Sep 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
COPD patients with Chronic Respiratory Failure	Device: Non-invasive ventilation NIV as in standard care

Arm

Intervention/Treatment

COPD patients with Chronic Respiratory Failure

Device: Non-invasive ventilation

NIV as in standard care

Outcome Measures

Primary Outcome Measures

Gas exchange [baseline]
Transcutaneous monitoring of gas exchange
Gas exchange [2 months]
Transcutaneous monitoring of gas exchange
Gas exchange [4 months]
Transcutaneous monitoring of gas exchange
Gas exchange [6 months]
Transcutaneous monitoring of gas exchange
Patient comfort [baseline]
Patient comfort assessed by VAS scale
Patient comfort [2 months]
Patient comfort assessed by VAS scale
Patient comfort [4 months]
Patient comfort assessed by VAS scale
Patient comfort [6 months]
Patient comfort assessed by VAS scale
AECOPD [2 months, 4 months, 6 months]
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
AECOPD [2 months]
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
AECOPD [4 months]
Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)
Hospitalisations for AECOPD [6 months]
Hospitalisations for acute exacerbations of COPD
Sleep quality [2 months]
Sleep quality assessing sleep depth and sleep stages
Sleep quality [4 months]
Sleep quality assessing sleep depth and sleep stages
Sleep quality [6 months]
Sleep quality assessing sleep depth and sleep stages

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Medical Center Groningen
University of Twente
Löwenstein BV
Vivisol
Sencure BV

Investigators

Principal Investigator: Marieke L Duiverman, University Medical Center Groningen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT05756387

Other Study ID Numbers:

16013

First Posted:

Mar 6, 2023

Last Update Posted:

Mar 6, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by University Medical Center Groningen

Monitoring

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Mar 6, 2023