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Pilot Study : New Sensors to Monitor Apnea During Sedation (JAWAC)

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ClinicalTrials.gov Identifier: NCT02909309
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Luc Barvais, Erasme University Hospital

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

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Anesthesia Device: JAWAC system + Capnoline + Spo2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study : Evaluation of a Mandibular and Abdominal Motion Detection Sensors (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Arm Intervention/treatment
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).

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909309


Locations
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Belgium
Erasme Hospital
Brussels, Belgium, 1070
Sponsors and Collaborators
Erasme University Hospital
Investigators
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Study Director: Luc Barvais Erasme University Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Luc Barvais, Professor and head of the cardiothoracic and vascular anesthesia Clinics, Erasme University Hospital
ClinicalTrials.gov Identifier: NCT02909309    
Other Study ID Numbers: P2016/329
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luc Barvais, Erasme University Hospital:
Propofol
Deep Sedation
Anoxia
Hypercapnia
Additional relevant MeSH terms:
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Apnea
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases