Pilot Study : New Sensors to Monitor Apnea During Sedation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Sleep Apnea, Obstructive Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ALL INCLUDED PATIENTS

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).

Group Type OTHER

JAWAC system + Capnoline + Spo2

Intervention Type DEVICE

measure mandibular mouvements + etCO2 + pulse oxymetry, respectively

Interventions

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JAWAC system + Capnoline + Spo2

measure mandibular mouvements + etCO2 + pulse oxymetry, respectively

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No