Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04872062
Recruitment Status : Recruiting
First Posted : May 4, 2021
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
SOLER Julien, Central Hospital, Nancy, France

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Chronic Hypercapnic Respiratory Failure Device: NIV cards Other: Medical file

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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 : November 1, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Agreement of responses to a standardized NIV reading grid between 2 observers [ Time Frame: 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 [ Time Frame: Day 0 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04872062


Contacts
Layout table for location contacts
Contact: Julien Soler +33647961454 soler.julien@yahoo.fr

Locations
Layout table for location information
France
CHRU de Nancy - Site de Brabois Recruiting
Nancy, France, 54000
Contact: Julien Soler    +33647961454    soler.julien@yahoo.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Layout table for investigator information
Study Director: Julien Soler CentraHNF
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: SOLER Julien, Hospital practitioner, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04872062    
Other Study ID Numbers: 2020PI282
First Posted: May 4, 2021    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SOLER Julien, Central Hospital, Nancy, France:
chronic hypercapnic respiratory failure
non-invasive ventilation
standardized NIV reading grid
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory