Clinical trial NCT02909309: Pilot Study : New Sensors to Monitor Apnea During Sedation
Official title: Pilot Study : Evaluation of a Mandibular and Abdominal Motion Detection Sensors (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Anesthesia
Keywords: Propofol
Deep Sedation
Anoxia
Hypercapnia
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2016-09-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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:

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

Primary outcomes:
measure: Optimal JAWAC signal threshold detecting obstructive apnea
timeFrame: at time of anesthesia
Secondary outcomes:
measure: Time limit between the detection of each system and the episode of désaturation
timeFrame: at time of anesthesia
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Erasme University Hospital
name: Luc Barvais
role: STUDY_DIRECTOR
References:
citation: Tinker JH, Dull DL, Caplan RA, Ward RJ, Cheney FW. Role of monitoring devices in prevention of anesthetic mishaps: a closed claims analysis. Anesthesiology. 1989 Oct;71(4):541-6. doi: 10.1097/00000542-198910000-00010.
citation: Senny F, Destine J, Poirrier R. Midsagittal jaw movement analysis for the scoring of sleep apneas and hypopneas. IEEE Trans Biomed Eng. 2008 Jan;55(1):87-95. doi: 10.1109/TBME.2007.899351.
citation: Niklewski PJ, Phero JC, Martin JF, Lisco SJ. A novel index of hypoxemia for assessment of risk during procedural sedation. Anesth Analg. 2014 Oct;119(4):848-856. doi: 10.1213/ANE.0000000000000371.
citation: Ponthieu N, Coeckelenbergh S, Engelman E, Tuna T, Van Obbergh L, Barvais L. Synchronized mandibular movement and capnography: a novel approach to obstructive airway detection during procedural sedation-a post hoc analysis of a prospective study. J Clin Monit Comput. 2019 Dec;33(6):1065-1070. doi: 10.1007/s10877-018-00250-3. Epub 2019 Jan 4.