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

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04872062
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 8.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hypercapnic Respiratory Failure	Device: NIV cards; Other: Medical file

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Monitoring of Patients With Chronic Respiratory Failure Traeted With Non-invasive Home Ventilation: Contribution of New Monitoring Tools
• Actual Study Start Date: Nov 1, 2020
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: May 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Chronic hypercapnic respiratory failure treated by home non-invasive ventilation (NIV)	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

Outcome Measures

Primary Outcome Measures

1. Agreement of responses to a standardized NIV reading grid between 2 observers [Day 0]

Secondary Outcome Measures

1. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHRU de Nancy - Site de Brabois	Nancy		France	54000

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

• Study Director: Julien Soler, CentraHNF

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SOLER Julien, Hospital practitioner, Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT04872062
• Other Study ID Numbers: 2020PI282
• First Posted: May 4, 2021
• Last Update Posted: May 4, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by SOLER Julien, Hospital practitioner, Central Hospital, Nancy, France: chronic hypercapnic respiratory failure; non-invasive ventilation; standardized NIV reading grid
• Additional relevant MeSH terms: Respiratory Insufficiency; Hypercapnia

Study Results

No Results Posted as of May 4, 2021