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

May 1, 2021 updated by: SOLER Julien, Central Hospital, Nancy, France

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nancy, France, 54000
        • Recruiting
        • CHRU de Nancy - Site de Brabois
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Agreement of responses to a standardized NIV reading grid between 2 observers
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Study Director: Julien Soler, CentraHNF

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

April 21, 2021

First Submitted That Met QC Criteria

May 1, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

May 1, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI282

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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