Monitoring of Patients With Chronic Respiratory Failure Treated With Non-invasive Home Ventilation: Contribution of New Monitoring Tools

• Conditions: Chronic Hypercapnic Respiratory Failure
• Interventions: Device: NIV cards; Other: Medical file

• Registration Number: NCT04872062
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

Single-center retrospective study conducted on a population of patients with chronic hypercapnic respiratory failure treated by non-invasive ventilation at home, followed at the CHRU of Nancy. The objective is to assess the contribution of reading the NIV card with a standardized grid in their follow-up. The main objective is to assess the inter-observer agreement of a standardized NIV card reading grid, the secondary objective is to compare the results of NIV card reading between the usual NIV card reading method in the service and this same method completed by the addition of the standardized reading grid. The hypothesis is that the use of a standardized NIV card reading grid improves patient follow-up by standardizing their care.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2021-04-21
• Status Verified: 2021-05
• Primary Completion: 2021-05
• Study Completion: 2021-05
• Study First Submitted QC: 2021-05-01
• Last Update Submitted: 2021-05-01
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Major patients
• Patients with chronic hypercapnic respiratory failure with a validated indication of long-term NIV
• Follow-up at the CHRU of Nancy at "Unité de Médecine Ambulatoire" (UMA) department between 11/01/2020 and 05/30/2021

Exclusion Criteria

• Data not usable / missing
• Tracheal ventilation
• Patients' opposition to the use of their data for the purposes of this research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic hypercapnic respiratory failure treated by home non-invasive ventilation (NIV)	NIV cards	-
Chronic hypercapnic respiratory failure treated by home non-invasive ventilation (NIV)	Medical file	-

Primary Outcome Measures

Name	Time	Method
Agreement of responses to a standardized NIV reading grid between 2 observers	Day 0

Secondary Outcome Measures

Name	Time	Method
Comparison of the results between two observers between the method of reading NIV card usually performed in the department and this same method supplemented with a standardized NIV reading grid	Day 0

Trial Locations

Locations (1)

CHRU de Nancy - Site de Brabois; 🇫🇷 Nancy, France