Pilot Study : New Sensors to Monitor Apnea During Sedation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02909309
• Date of registration: 13/09/2016
• Prospective Registration: Yes
• Primary sponsor: Erasme University Hospital
• Public title: Pilot Study : New Sensors to Monitor Apnea During Sedation JAWAC
• Scientific title: Pilot Study : Evaluation of a Mandibular and Abdominal Motion Detection Sensors (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode
• Date of first enrolment: March 1, 2017
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02909309
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium

Contacts

• Name: Luc Barvais
• Affiliation: Erasme University Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sleep Apnea, Obstructive

Anesthesia

Intervention(s)

Device: JAWAC system + Capnoline + Spo2

Primary Outcome(s)

Optimal JAWAC signal threshold detecting obstructive apnea [Time Frame: at time of anesthesia]

Secondary Outcome(s)

Time limit between the detection of each system and the episode of désaturation [Time Frame: at time of anesthesia]

Secondary ID(s)

P2016/329

Source(s) of Monetary Support

Please refer to primary and secondary sponsors