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

• Sponsor: Erasme University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02909309
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arm: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive; Anesthesia	Device: JAWAC system + Capnoline + Spo2	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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: Mar 1, 2017
• Actual Primary Completion Date: Jul 31, 2017
• Actual Study Completion Date: Jul 31, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasme Hospital	Brussels		Belgium	1070

Sponsors and Collaborators

• Erasme University Hospital

Investigators

• Study Director: Luc Barvais, Erasme University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• Senny F, Destiné 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.
• 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.

• Responsible Party: Luc Barvais, Professor and head of the cardiothoracic and vascular anesthesia Clinics, Erasme University Hospital
• ClinicalTrials.gov Identifier: NCT02909309
• Other Study ID Numbers: P2016/329
• First Posted: Sep 21, 2016
• Last Update Posted: Aug 23, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Luc Barvais, Professor and head of the cardiothoracic and vascular anesthesia Clinics, Erasme University Hospital: Propofol; Deep Sedation; Anoxia; Hypercapnia
• Additional relevant MeSH terms: Apnea; Sleep Apnea, Obstructive

Study Results

No Results Posted as of Aug 23, 2018