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Completed

NCT Number: NCT02909309

Pilot Study : New Sensors to Monitor Apnea During Sedation

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

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Key information

Conditions

Sleep Apnea, Obstructive Anesthesia Apnea Dyssomnias Hypercapnia Hypoxia Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasme Hospital

Brussels, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

JAWAC system + Capnoline + Spo2

Device

measure mandibular mouvements + etCO2 + pulse oxymetry, respectively

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Acronym: JAWAC

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2016
Registry last updated
Aug 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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