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

Chronic Hypercapnic Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04872062
• Other study ID #: 2020PI282
• Status: Recruiting
• Start date: November 1, 2020
• Est. completion date: May 2021

Study information

• Verified date: May 2021
• Source: Central Hospital, Nancy, France
• Contact: Julien Soler
• Phone: +33647961454
• Email: soler.julien[@]yahoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hypercapnic Respiratory Failure
• Hypercapnia
• Respiratory Insufficiency

Intervention

Device:
• NIV cards
Reading the data available on the NIV cards

Other:
• Medical file
Using the data available in the medical file including clinical data, blood gas results, nocturnal oximetry results

Locations

Country	Name	City	State
France	CHRU de Nancy - Site de Brabois	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement of responses to a standardized NIV reading grid between 2 observers		Day 0
Secondary	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