NCT02909309

Pilot Study : New Sensors to Monitor Apnea During Sedation

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea, Obstructive
• Anesthesia

Interventions

Type	Name	Description
DEVICE	JAWAC system + Capnoline + Spo2	measure mandibular mouvements + etCO2 + pulse oxymetry, respectively

Timeline

• Start date: 2017-03-01
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2016-09-21
• Last updated: 2018-08-23

Locations

1 site across 1 country: Belgium