Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach (NOCTIVENT)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Respiratory Failure; Non-invasive Ventilation
• Intervention / Treatment: Device: Non-invasive ventilation

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Marieke L Duiverman, MD PhD; Phone Number: 0031503613200; Email: m.l.duiverman@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: University of Twente; Vivisol; Löwenstein BV; Sencure BV
• Investigators: Principal Investigator: Marieke L Duiverman, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Monitoring
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 16013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No