An observational study in Interface, Mask, Continuous Positive Airway Pressure (CPAP) and Non Invasive Ventilation (NIV), sponsored by University Hospital, Montpellier. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by University Hospital, Montpellier · Observational
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.
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.
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.
Exclusion Criteria:
* Interface side effects and degree of satisfaction of the patients * Technician evaluation and device measures.
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.
Time frame: 1 day
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day
Compliance
During a scheduled home visit of the technician : Device software data: compliance (hour per day) over the last 3 months
Time frame: 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)
Time frame: 1 day
Residual AHI
During a scheduled home visit of the technician : Device software data: residual AHI (event/hour)
Time frame: 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).
Time frame: 1 day
Patient quality of life questionnaire
Patient quality of life questionnaire (EQ-5D 3L, Epworth).
Time frame: 1 day
Date of first installation of the first ventilation device
Date of first installation of the first ventilation device
Time frame: 1 day
Proportion of patient responding to self-help questionnaire without assistance
Proportion of patient responding to self-help questionnaire without assistance
Time frame: 1 day
Proportion of patients able to position the interface without assistance
Proportion of patients able to position the interface without assistance
Time frame: 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.
Time frame: 1 day
Proportion of patient waiting for a new interface
Proportion of patient waiting for a new interface
Time frame: 1 day
Proportion of patients wishing to participate in research on the subject.
Proportion of patients wishing to participate in research on the subject.
Time frame: 1 day
Plan to share: Undecided
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University Hospital, Montpellier