Monitoring of Patients With Chronic Respiratory Failure Treated With Non-invasive Home Ventilation: Contribution of New Monitoring Tools
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2020
CompletedFirst Submitted
Initial submission to the registry
April 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedFirst Posted
Study publicly available on registry
May 4, 2021
CompletedMay 4, 2021
May 1, 2021
6 months
April 21, 2021
May 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Agreement of responses to a standardized NIV reading grid between 2 observers
Day 0
Secondary Outcomes (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
Study Arms (1)
Chronic hypercapnic respiratory failure treated by home non-invasive ventilation (NIV)
Interventions
Reading the data available on the NIV cards
Using the data available in the medical file including clinical data, blood gas results, nocturnal oximetry results
Eligibility Criteria
Adult patients with chronic hypercapnic respiratory failure, treated with NIV at home, followed at the CHRU of Nancy in the UMA department between 11/01/2020 and 05/30/2021
You may qualify if:
- 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
You may not qualify if:
- Data not usable / missing
- Tracheal ventilation
- Patients' opposition to the use of their data for the purposes of this research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHRU de Nancy - Site de Brabois
Nancy, 54000, France
Study Officials
- STUDY DIRECTOR
Julien Soler
CentraHNF
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hospital practitioner
Study Record Dates
First Submitted
April 21, 2021
First Posted
May 4, 2021
Study Start
November 1, 2020
Primary Completion
May 1, 2021
Study Completion
May 1, 2021
Last Updated
May 4, 2021
Record last verified: 2021-05