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

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: Completed
• Conditions: Interface, Mask; Continuous Positive Airway Pressure (CPAP); Non Invasive Ventilation (NIV); Hyperventilation Anxiety; Sleep Apnea Syndrome (OSAS)
• Intervention / Treatment: Other: self questionnaire

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: Observational
• Enrollment (Actual): 6000

Contacts and Locations

Study Locations

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

Participation Criteria

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

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interface side effects and degree of satisfaction of the patients	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

Outcome Measure	Measure Description	Time Frame
Identification by the technician of the problems of pain	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.	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	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	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	During a scheduled home visit of the technician : Device software data: average level of intentional or unintentional leakage (l/min)	1 day
Residual AHI	During a scheduled home visit of the technician : Device software data: residual AHI (event/hour)	1 day
Average pressure level and pressure	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	Patient quality of life questionnaire (EQ-5D 3L, Epworth).	1 day
Date of first installation of the first ventilation device	Date of first installation of the first ventilation device	1 day
Proportion of patient responding to self-help questionnaire without assistance	Proportion of patient responding to self-help questionnaire without assistance	1 day
Proportion of patients able to position the interface without assistance	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 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	Proportion of patient waiting for a new interface	1 day
Proportion of patients wishing to participate in research on the subject.	Proportion of patients wishing to participate in research on the subject.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Dany JAFFUEL, MD, PhD, University Hospital, Montpellier

Publications and helpful links

General Publications

• Rotty MC, Mallet JP, Suehs CM, Martinez C, Borel JC, Rabec C, Bourdin A, Molinari N, Jaffuel D. Is the 2013 American Thoracic Society CPAP-tracking system algorithm useful for managing non-adherence in long-term CPAP-treated patients? Respir Res. 2019 Sep 12;20(1):209. doi: 10.1186/s12931-019-1150-7.
• Rotty MC, Suehs CM, Mallet JP, Martinez C, Borel JC, Rabec C, Bertelli F, Bourdin A, Molinari N, Jaffuel D. Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study. Respir Res. 2021 Jan 15;22(1):17. doi: 10.1186/s12931-021-01618-x.

Helpful Links

• InterfaceVent on the Open Science Framework

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: December 23, 2016
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (Estimate): January 6, 2017

Study Record Updates

• Last Update Posted (Actual): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 24, 2021
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Hyperventilation
• Other Study ID Numbers: RECHMPL16_0337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED