NCT02909309

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

September 13, 2016

Last Update Submit

August 22, 2018

Conditions

Sleep Apnea, ObstructiveAnesthesia

Keywords

PropofolDeep SedationAnoxiaHypercapnia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Time limit between the detection of each system and the episode of désaturation

    at time of anesthesia

Study Arms (1)

ALL INCLUDED PATIENTS

OTHER

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

Interventions

JAWAC system + Capnoline + Spo2DEVICE

measure mandibular mouvements + etCO2 + pulse oxymetry, respectively

ALL INCLUDED PATIENTS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any adult patient scheduled for a sleep apnea provocation test under sedation by propofol
  • Hospital Erasme during the period of the study.

You may not qualify if:

  • Patient Refusal
  • Patient Age: 18 years and under 80 years
  • Intervention earlier in the mandible or thorax
  • A history of facial burn
  • Allergy tape

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

Related Publications (4)

  • 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.

    PMID: 2508510BACKGROUND

  • 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.

    PMID: 18232350BACKGROUND

  • 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.

    PMID: 25232693BACKGROUND

  • 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.

    PMID: 30610518DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypoxiaHypercapnia

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Luc Barvais

    Erasme University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and head of the cardiothoracic and vascular anesthesia Clinics

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 21, 2016

Study Start

March 1, 2017

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

August 23, 2018

Record last verified: 2018-08

Locations

BE(1)