Sleep Apnea, ObstructiveJAWACNCT02909309
Pilot Study : New Sensors to Monitor Apnea During Sedation
A study testing JAWAC system + Capnoline + Spo2 in people with Sleep Apnea, Obstructive and Anesthesia, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea, Obstructive, Anesthesia
- What is being tested?
- JAWAC system + Capnoline + Spo2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2017to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any adult patient scheduled for a sleep apnea provocation test under sedation by propofol
- Hospital Erasme during the period of the study.
Who cannot join
- Patient Refusal
- Patient Age: 18 years and under 80 years
- Intervention earlier in the mandible or thorax
- A history of facial burn
- Allergy tape
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study : Evaluation of a Mandibular and Abdominal Motion Detection Sensors (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode
Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode
Read the 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.
- Conditions
- Sleep Apnea, Obstructive, Anesthesia
- Being tested
- JAWAC system + Capnoline + Spo2
- Keywords
- Propofol, Deep Sedation, Anoxia, Hypercapnia
- Medical subject headings
- Sleep Apnea, Obstructive, Hypoxia, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAWAC system + Capnoline + Spo2Device
measure mandibular mouvements + etCO2 + pulse oxymetry, respectively
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: JAWAC system + Capnoline + Spo2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at time of anesthesia
Secondary outcomes (1)
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.
Measured: at time of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start1 Mar 2017
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Barvais, Erasme University Hospital
- Investigators
- Luc Barvais, Study director, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909309
- Sponsor's protocol ID
- P2016/329
- Acronym
- JAWAC
- Status last verified
- Aug 2018
- First submitted
- 13 Sep 2016
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 2508510Senny 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.
PubMed 18232350Niklewski 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.
PubMed 25232693Ponthieu 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.
PubMed 30610518
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study : Evaluation of a Mandibular and Abdominal Motion Detection Sensors (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode
- ClinicalTrials.gov ID
- NCT02909309
- Acronym / sponsor ID
- JAWAC / P2016/329
- Conditions
- Sleep Apnea, Obstructive, Anesthesia
- Keywords
- Propofol, Deep Sedation, Anoxia, Hypercapnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of a Mandibular and Abdominal Motion Detection Sensor (JAWAC) to Prevent Apnea During Sedation With Propofol in TCI Mode
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALL INCLUDED PATIENTS | Other | Device: JAWAC system + Capnoline + Spo2A 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any adult patient scheduled for a sleep apnea provocation test under sedation by propofol
- Hospital Erasme during the period of the study.
Key exclusion criteria (5 listed)
- Patient Refusal
- Patient Age: 18 years and under 80 years
- Intervention earlier in the mandible or thorax
- A history of facial burn
- Allergy tape
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JAWAC system + Capnoline + Spo2measure mandibular mouvements + etCO2 + pulse oxymetry, respectively | Device | ALL INCLUDED PATIENTS |
Primary outcome
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.
1 secondary outcome
Time limit between the detection of each system and the episode of désaturation
Time frame: at time of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Background: PubMed 2508510Tinker 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.
- Background: PubMed 18232350Senny 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.
- Background: PubMed 25232693Niklewski 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.
- Derived from this study: PubMed 30610518Ponthieu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc Barvais study director
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JAWAC system + Capnoline + Spo2 in people with Sleep Apnea, Obstructive and Anesthesia, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal JAWAC signal threshold detecting obstructive apnea (time frame: at time of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02909309, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.