Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

Chronic Respiratory Failure Clinical Trial

— NOCTIVENT  

Official title:

Improving Chronic Nocturnal Noninvasive Ventilation: a Multimodality Approach

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05756387
• Other study ID #: 16013
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: September 1, 2028

Study information

• Verified date: November 2023
• Source: University Medical Center Groningen
• Contact: Marieke L Duiverman, MD PhD
• Phone: 0031503613200
• Email: m.l.duiverman[@]umcg.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2028
• Est. primary completion date: January 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Respiratory Failure
• Non-invasive Ventilation
• Respiratory Insufficiency

Intervention

Device:
• Non-invasive ventilation
NIV as in standard care

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University Medical Center Groningen	Löwenstein BV, Sencure BV, University of Twente, Vivisol

Outcome

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