Pilot Study : New Sensors to Monitor Apnea During Sedation (JAWAC)

Free University of Brussels (ULB)

Status: Completed

Conditions: Sleep Apnea, Obstructive; Anesthesia

Treatments: Device: JAWAC system + Capnoline + Spo2

Study type: Interventional

Funder types: Other

Identifiers

NCT02909309

P2016/329

Details and patient eligibility

About

Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

ALL INCLUDED PATIENTS

Other group

Description:

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).

Treatment:

Device: JAWAC system + Capnoline + Spo2