Pilot Study : New Sensors to Monitor Apnea During Sedation (JAWAC)

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

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

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Anesthesia
• Intervention / Treatment: Device: JAWAC system + Capnoline + Spo2

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Erasme hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at time of anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at time of anesthesia

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Investigators: Study Director: Luc Barvais, Erasme University Hospital

Publications and helpful links

General Publications

• Tinker JH, Dull DL, Caplan RA, Ward RJ, Cheney FW. Role of monitoring devices in prevention of anesthetic mishaps: a closed claims analysis. Anesthesiology. 1989 Oct;71(4):541-6. doi: 10.1097/00000542-198910000-00010.
• Senny F, Destine J, Poirrier R. Midsagittal jaw movement analysis for the scoring of sleep apneas and hypopneas. IEEE Trans Biomed Eng. 2008 Jan;55(1):87-95. doi: 10.1109/TBME.2007.899351.
• Niklewski PJ, Phero JC, Martin JF, Lisco SJ. A novel index of hypoxemia for assessment of risk during procedural sedation. Anesth Analg. 2014 Oct;119(4):848-856. doi: 10.1213/ANE.0000000000000371.
• Ponthieu N, Coeckelenbergh S, Engelman E, Tuna T, Van Obbergh L, Barvais L. Synchronized mandibular movement and capnography: a novel approach to obstructive airway detection during procedural sedation-a post hoc analysis of a prospective study. J Clin Monit Comput. 2019 Dec;33(6):1065-1070. doi: 10.1007/s10877-018-00250-3. Epub 2019 Jan 4.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: September 13, 2016
• First Submitted That Met QC Criteria: September 18, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): August 23, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Propofol; Hypercapnia; Deep Sedation; Anoxia
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: P2016/329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No