NCT05756387

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Dec 2024Dec 2028

First Submitted

Initial submission to the registry

February 13, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

February 13, 2023

Last Update Submit

December 9, 2024

Conditions

Chronic Respiratory FailureNon-invasive Ventilation

Keywords

Monitoring

Outcome Measures

Primary Outcomes (15)

  • Gas exchange

    Transcutaneous monitoring of gas exchange

    baseline

  • Gas exchange

    Transcutaneous monitoring of gas exchange

    2 months

  • Gas exchange

    Transcutaneous monitoring of gas exchange

    4 months

  • Gas exchange

    Transcutaneous monitoring of gas exchange

    6 months

  • Patient comfort

    Patient comfort assessed by VAS scale

    baseline

  • Patient comfort

    Patient comfort assessed by VAS scale

    2 months

  • Patient comfort

    Patient comfort assessed by VAS scale

    4 months

  • Patient comfort

    Patient comfort assessed by VAS scale

    6 months

  • AECOPD

    Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)

    2 months, 4 months, 6 months

  • AECOPD

    Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)

    2 months

  • AECOPD

    Acute exacerbations of COPD (defines as deterioration of symptoms requiring a course of/increase in Prednisolone dose and/or antibiotics)

    4 months

  • Hospitalisations for AECOPD

    Hospitalisations for acute exacerbations of COPD

    6 months

  • Sleep quality

    Sleep quality assessing sleep depth and sleep stages

    2 months

  • Sleep quality

    Sleep quality assessing sleep depth and sleep stages

    4 months

  • Sleep quality

    Sleep quality assessing sleep depth and sleep stages

    6 months

Study Arms (1)

COPD patients with Chronic Respiratory Failure

Device: Non-invasive ventilation

Interventions

Non-invasive ventilationDEVICE

NIV as in standard care

COPD patients with Chronic Respiratory Failure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COPD patients with chronic hypercapnic respiratory failure needing chronic NIV will be included

You may qualify if:

  • COPD patients indicated for chronic home NIV

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMCG

Groningen, Netherlands

RECRUITING

MeSH Terms

Interventions

Noninvasive Ventilation

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Marieke L Duiverman

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marieke L Duiverman, MD PhD

CONTACT

0031503613200m.l.duiverman@umcg.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

March 6, 2023

Study Start

December 1, 2024

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

December 13, 2024

Record last verified: 2024-12

Locations

NL(1)