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

Completed

• Conditions: Hyperventilation Anxiety; Non Invasive Ventilation (NIV); Interface, Mask; Continuous Positive Airway Pressure (CPAP); Sleep Apnea Syndrome (OSAS)

• Registration Number: NCT03013283
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-12-23
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Study Start: 2017-02-07
• Status Verified: 2019-04
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Last Update Submitted: 2021-01-24
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interface side effects and degree of satisfaction of the patients	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.

Secondary Outcome Measures

Name	Time	Method
Compliance	1 day	During a scheduled home visit of the technician : Device software data: compliance (hour per day) over the last 3 months
Average level of intentional or unintentional leakage	1 day	During a scheduled home visit of the technician : Device software data: average level of intentional or unintentional leakage (l/min)
Collection by technician of the type of interface	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.
Residual AHI	1 day	During a scheduled home visit of the technician : Device software data: residual AHI (event/hour)
Patient quality of life questionnaire	1 day	Patient quality of life questionnaire (EQ-5D 3L, Epworth).
Date of first installation of the first ventilation device	1 day	Date of first installation of the first ventilation device
Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.	1 day	Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.
Identification by the technician of the problems of pain	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.
Proportion of patients able to position the interface without assistance	1 day	Proportion of patients able to position the interface without assistance
Proportion of patient waiting for a new interface	1 day	Proportion of patient waiting for a new interface
Proportion of patients wishing to participate in research on the subject.	1 day	Proportion of patients wishing to participate in research on the subject.
Percentage of patients with oxygen therapy, heated humidifier, chinstrap.	1 day	During a scheduled home visit of the technician : Percentage of patients with oxygen therapy, heated humidifier, chinstrap.
Average pressure level and pressure	1 day	During a scheduled home visit of the technician :Device software data: average pressure level and pressure at the 90/95th percentile (cmH2O).
Proportion of patient responding to self-help questionnaire without assistance	1 day	Proportion of patient responding to self-help questionnaire without assistance

Trial Locations

Locations (2)

CHU Saint-Etienne; 🇫🇷 Saint-Etienne, France

Centre Hospitalier Universitaire de Montpellier; 🇫🇷 Montpellier, France