CPAP and NIV Interfaces : Side-effects in Home Care Patients (InterfaceVent)

January 24, 2021 updated by: University Hospital, Montpellier

Descriptional Study of the Side Effects Related to the Use of the Interface in Home Care Patients Treated for at Least 3 Months by Continuous Positive Pressure or Non-Invasive Ventilation.

Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are delivered to the patient via an interface.

The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the device. Because the comfort and degree of satisfaction of the patients to its interface is a key factor of the observance, side-effects and satisfaction of patients need to be continuously evaluated with available interfaces for CPAP and NIV treated patients.

The purpose of the research is the evaluation of interface side-effects and the degree of satisfaction of home care patients treated for at least three months with CPAP or NIV.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway Pressure or CPAP (the level of pressure delivered being constant) and Non Invasive Ventilation or NIV (pressure level varies from an expiratory pressure to an inspiratory pressure). Whether for CPAP or NIV, pressures are delivered to the patient via an interface. Many manufacturers produce interfaces and these interfaces are the subject of regular technological innovations with the introduction on the market of new product ranges.

Because of the lack of dedicated and actualized studies, there is poor evidence based of difference between old and new interfaces, there is also poor evidence based of differences between manufacturer products.

The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the device. Because the comfort and degree of satisfaction of the patients to its interface is a key factor of the observance, side-effects and satisfaction of patients need to be continuously evaluated with available interfaces for CPAP and NIV treated patients.

The purpose of the research is the evaluation of interface side-effects and the degree of satisfaction of home care patients treated for at least three months with CPAP or NIV. A visual analog scale is used to assess the patient perception of its interface. A measure of the quality of life and a home care technician evaluation are performed simultaneously. Using the device manufacturer software, a measure of the observance, level of pressure and leak is realised.

A first intermediate analysis will be made after approximately 1000 inclusions (the Sleepileaks (determinants of residual excessive sleapiness), Threshleaks (high leak levels and machine adherence as defined by the American Thoracic Society) and Complileaks studies (all leaks and machine adherence as continuous variables)). A second validating analysis will be made at the end of inclusions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6000

Contacts and Locations

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

Study Locations

  • France
      • Montpellier, France, 34295
        • Centre Hospitalier Universitaire de Montpellier
      • Saint-Etienne, France, 42055
        • CHU Saint-Etienne

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

The patients included in the study corresponded to the annual cohort of patients cared by the APARD home care provider. Patients are were treated with CPAP or VIN for more than 3 months according to the criteria of care and reimbursement of the French Social Security rules.

Description

Inclusion Criteria:

  • Written informed consent
  • Age more than 18 years (inclusive)
  • Patient treated with CPAP or NIV for at least three months,and eligible for care and for the reimbursement by the French Social Security rules.
  • Patient presents during a scheduled home visit of the technician for the continuation of CPAP or NIV treatment according to the French Social Security rules.

Exclusion Criteria:

  • Pregnancy, intention of being pregnant, breastfeeding.
  • Inability to understand the nature and aims of the study or to communicate with the investigator
  • Simultaneous participation in another trial with an exclusion clause to participate to an other trial.
  • No affiliation to the French social security
  • Loss of personal capacity resulting in state protection
  • Deprivation of liberty by judicial or administrative decision

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Interface side effects and degree of satisfaction of the patients
Time Frame: 1 day
During a scheduled home visit of the technician. The primary endpoint is a composite criterion corresponding to the patients' responses to a self-administered questionnaire.
1 day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Identification by the technician of the problems of pain
Time Frame: 1 day
During a scheduled home visit of the technician : Identification by the technician of the problems of pain, erythema and leak, localization of these problems.
1 day
Percentage of patients with oxygen therapy, heated humidifier, chinstrap.
Time Frame: 1 day
During a scheduled home visit of the technician : Percentage of patients with oxygen therapy, heated humidifier, chinstrap.
1 day
Collection by technician of the type of interface
Time Frame: 1 day
During a scheduled home visit of the technician : Collection by technician of the type of interface (nasal pillows, nasal and oronasal, custom made interface), manufacturer name and interface size, type (CPAP/NIV) and manufacturer name of the device.
1 day
Compliance
Time Frame: 1 day
During a scheduled home visit of the technician : Device software data: compliance (hour per day) over the last 3 months
1 day
Average level of intentional or unintentional leakage
Time Frame: 1 day
During a scheduled home visit of the technician : Device software data: average level of intentional or unintentional leakage (l/min)
1 day
Residual AHI
Time Frame: 1 day
During a scheduled home visit of the technician : Device software data: residual AHI (event/hour)
1 day
Average pressure level and pressure
Time Frame: 1 day
During a scheduled home visit of the technician :Device software data: average pressure level and pressure at the 90/95th percentile (cmH2O).
1 day
Patient quality of life questionnaire
Time Frame: 1 day
Patient quality of life questionnaire (EQ-5D 3L, Epworth).
1 day
Date of first installation of the first ventilation device
Time Frame: 1 day
Date of first installation of the first ventilation device
1 day
Proportion of patient responding to self-help questionnaire without assistance
Time Frame: 1 day
Proportion of patient responding to self-help questionnaire without assistance
1 day
Proportion of patients able to position the interface without assistance
Time Frame: 1 day
Proportion of patients able to position the interface without assistance
1 day
Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.
Time Frame: 1 day
Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.
1 day
Proportion of patient waiting for a new interface
Time Frame: 1 day
Proportion of patient waiting for a new interface
1 day
Proportion of patients wishing to participate in research on the subject.
Time Frame: 1 day
Proportion of patients wishing to participate in research on the subject.
1 day

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dany JAFFUEL, MD, PhD, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL16_0337

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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