Pilot Study : New Sensors to Monitor Apnea During Sedation

Anesthesia Clinical Trial

— JAWAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909309
• Other study ID #: P2016/329
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2018
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Apnea
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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):848-56. doi: 10.1213/ANE.0000000000000371. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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