Pilot Study : New Sensors to Monitor Apnea During Sedation

Study Overview
=================
Brief Summary
-----------------
Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode

Detailed Description
-----------------
In 2016 , monitoring of propofol sedation , currently recommended by the American Society of Anaesthesiology and European companies includes among others, a pulse oximeter (SpO2) and a continuous measurement of CO2 exhaled by an appropriate device (CapnoLine). This monitoring does not allow to anticipate the occurrence of obstructive apnea . The anticipation of the occurrence of apnea or airway obstruction using this type of monitoring could allow the anesthesiologist to act earlier on the titration of propofol and maintaining the airway. This would avoid the side effects associated with hypoxemia and hypercapnia and therefore further improve patient safety . This pilot study tests the JAWAC system to detect those apneas. This is an interventional diagnostic study on the JAWAC monitoring system validation in a prospective cohort of patients undergoing sedation in order to provoke sleep apnea. Indeed , sedation technique is already used with propofol during snoring provocation tests in patients at risk for sleep apnea.

Official Title
-----------------
Pilot Study : Evaluation of a Mandibular and Abdominal Motion Detection Sensors (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode

Conditions
-----------------
Sleep Apnea, Obstructive, Anesthesia

Intervention / Treatment
-----------------
* Device: JAWAC system + Capnoline + Spo2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient scheduled for a sleep apnea provocation test under sedation by propofol Hospital Erasme during the period of the study. Exclusion Criteria: Patient Refusal Patient Age: 18 years and under 80 years Intervention earlier in the mandible or thorax A history of facial burn Allergy tape

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ALL INCLUDED PATIENTS<br>A single arm for this study. All the patients benefit of both systems. The participants are their own control. Non invasive sensors are used to monitor and record data of those two systems in a synchron way ( JAWAC / Capnoline + Spo2). | Device: JAWAC system + Capnoline + Spo2<br>* measure mandibular mouvements + etCO2 + pulse oxymetry, respectively<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimal JAWAC signal threshold detecting obstructive apnea | The apnea is defined clinically by the anesthesiologist with the help of the capnoLine/Spo2. The purpose is to define the optimal signal detection during a continuous record of the system JAWAC associated with the occurrence of obstructive apnea. The results will give a variation in centimeters for a certain amount of time. It is possible that the optimal signal detection will be a combination of different sensors. The sensibility, specificity versus precocity of the signal will be studied. | at time of anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time limit between the detection of each system and the episode of désaturation | The assumption is that the signal JAWAC enable an earlier response of the anesthetist and a priori reduce the occurrence of desaturation at the onset of obstructive apnea compared to the capnoLine/spo2 system. | at time of anesthesia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Propofol, Deep Sedation, Anoxia, Hypercapnia