Continuous Positive Airway Pressure (CPAP) Clinical Trial
— InterfaceVentOfficial title:
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.
| Verified date | April 2019 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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.
| Status | Completed |
| Enrollment | 6000 |
| Est. completion date | April 1, 2019 |
| Est. primary completion date | April 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Universitaire de Montpellier | Montpellier | |
| France | CHU Saint-Etienne | Saint-Etienne |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
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 — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Compliance | During a scheduled home visit of the technician : Device software data: compliance (hour per day) over the last 3 months | 1 day | |
| Secondary | 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 | |
| Secondary | Residual AHI | During a scheduled home visit of the technician : Device software data: residual AHI (event/hour) | 1 day | |
| Secondary | 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 | |
| Secondary | Patient quality of life questionnaire | Patient quality of life questionnaire (EQ-5D 3L, Epworth). | 1 day | |
| Secondary | Date of first installation of the first ventilation device | Date of first installation of the first ventilation device | 1 day | |
| Secondary | Proportion of patient responding to self-help questionnaire without assistance | Proportion of patient responding to self-help questionnaire without assistance | 1 day | |
| Secondary | Proportion of patients able to position the interface without assistance | Proportion of patients able to position the interface without assistance | 1 day | |
| Secondary | 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 | |
| Secondary | Proportion of patient waiting for a new interface | Proportion of patient waiting for a new interface | 1 day | |
| Secondary | Proportion of patients wishing to participate in research on the subject. | Proportion of patients wishing to participate in research on the subject. | 1 day |