Pilot Study : New Sensors to Monitor Apnea During Sedation

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive; Anesthesia
• Interventions: Device: JAWAC system + Capnoline + Spo2

• Registration Number: NCT02909309
• Lead Sponsor: Erasme University Hospital

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.

Study Timeline

• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-18
• Study First Posted: 2016-09-21
• Study Start: 2017-03-01
• Primary Completion: 2017-07-31
• Study Completion: 2017-07-31
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALL INCLUDED PATIENTS	JAWAC system + Capnoline + Spo2	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Erasme Hospital; 🇧🇪 Brussels, Belgium