Pilot Study : New Sensors to Monitor Apnea During Sedation

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 31, 2017

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.

Interventions

  • Device: JAWAC system + Capnoline + Spo2
    • measure mandibular mouvements + etCO2 + pulse oxymetry, respectively

Arms, Groups and Cohorts

  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Erasme University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Luc Barvais, Professor and head of the cardiothoracic and vascular anesthesia Clinics – Erasme University Hospital
  • Overall Official(s)
    • Luc Barvais, Study Director, Erasme University Hospital

References

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.

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