Anesthesia, Sleep Apnea, Obstructive
Conditions
Keywords
Propofol, Deep Sedation, Anoxia, Hypercapnia
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.
Interventions
DEVICEJAWAC system + Capnoline + Spo2
measure mandibular mouvements + etCO2 + pulse oxymetry, respectively
Sponsors
Erasme University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
1. Patient Refusal 2. Patient Age: 18 years and under 80 years 3. Intervention earlier in the mandible or thorax 4. A history of facial burn 5. Allergy tape
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal JAWAC signal threshold detecting obstructive apnea | at time of anesthesia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time limit between the detection of each system and the episode of désaturation | at time of anesthesia | 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. |
Countries
Belgium
Outcome results
None listed