Pilot Study : New Sensors to Monitor Apnea During Sedation (JAWAC)
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|ClinicalTrials.gov Identifier: NCT02909309|
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : August 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive Anesthesia||Device: JAWAC system + Capnoline + Spo2||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study : Evaluation of a Mandibular and Abdominal Motion Detection Sensors (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||July 31, 2017|
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).
Device: JAWAC system + Capnoline + Spo2
measure mandibular mouvements + etCO2 + pulse oxymetry, respectively
- Optimal JAWAC signal threshold detecting obstructive apnea [ Time Frame: 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.
- Time limit between the detection of each system and the episode of désaturation [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909309
|Brussels, Belgium, 1070|
|Study Director:||Luc Barvais||Erasme University Hospital|