Pilot Study : New Sensors to Monitor Apnea During Sedation

Erasme University Hospital21 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Sleep Apnea, Obstructive Anesthesia

Interventions

JAWAC system + Capnoline + Spo2DEVICE

measure mandibular mouvements + etCO2 + pulse oxymetry, respectively

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Erasme Hospital

Brussels, Belgium

Outcomes

Primary Outcomes

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.

Time frame: at time of anesthesia

Secondary Outcomes

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.

Time frame: at time of anesthesia

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.