ApneaSafeSedNCT02968797
Clinical Comparative Study to Validate Performance of SafeSed Prototype Monitoring Endoscopy Under Sedation
An observational study of Apnea, run by Meir Medical Center at 1 site in Israel.
Trial summary
SafeSed prototype monitors respiratory parameters by tracking chest movements with optical and accelerometer markers. The respiratory parameters are compared to respiratory parameters measured by a spirometer and a capnograph. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Apnea
- What is being tested?
- SafeSed
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2016to 1 Dec 2019
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled to perform endoscopy procedures under sedation
Who may be able to join
- class 1-3 per American Society Anesthesiologists Physical Status Classification
- Subject signed Informed Concent Form
Who cannot join
- Pregnancy
- Unresolved pulmonary infection requiring active treatment
- Chronic pulmonary disease
- Any othe medical condition, that treating physician determines participating in the study is unadvisable
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir Medical Center
Kfar Saba, 4428331
Brian Fredman, MD, +97297471545, Fredman.brian@clalit.org.il
Edna Zohar, MD, +97297471545, Zohar.edna@clalit.org.il
About this study
Official title: SafeSed Validation Study, Comparing Performance to Capnography, as a Monitoring Technology of Respiratory Parameters
SafeSed prototype monitors respiratory parameters by tracking chest movements with optical and accelerometer markers. The respiratory parameters are compared to respiratory parameters measured by a spirometer and a capnograph.
Read the detailed description
Patients performing endoscopy procedures under sedation at the gastro clinic will be monitored by SafeSed in addition to being monitored by capnography, used by an anaesthetist. All patients will be monitored using the same two techniques (SafeSed and Capnography). No clinical decisions will be made based upon the data generated by the SafeSed system.
The data from all sources will be compared (post factum) to validate SafeSed performance.
The data collected on the SafeSed prototype will not be used for treatment of the patient.
The comparative analysis will be free vto be used by the sponsor.
- Conditions
- Apnea
- Being tested
- SafeSed
- Medical subject headings
- Apnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SafeSedDevice
Monitor respiratory parameters
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparative data of monitoring respiratory by 2 technologies
Validation of SafeSed performance by comparing to capnography. The respiratory rate (RR) and end tidal carbon dioxide (ETCO2) levels will be collected into a personal computer, and stored with a continuous time-stamp. RR, tidal volume (TD) and minute ventilatio (MV) calculations using the SafeSed markers chest movements will be stored at the same PC using the same time-stamp. Comparison will show correlation between deterioration events of respiratory parameters. This comparison will be the outcome of off-line analysis.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ApneaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Fredman, MD, Principal investigator, Israel: Clalit Health bServices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968797
- Sponsor's protocol ID
- 0143-16-MMC
- Acronym
- SafeSed
- Status last verified
- Mar 2018
- First submitted
- 7 Sep 2016
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SafeSed Validation Study, Comparing Performance to Capnography, as a Monitoring Technology of Respiratory Parameters
- ClinicalTrials.gov ID
- NCT02968797
- Acronym / sponsor ID
- SafeSed / 0143-16-MMC
- Conditions
- Apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 21 Nov 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.
SafeSed prototype monitors respiratory parameters by tracking chest movements with optical and accelerometer markers. The respiratory parameters are compared to respiratory parameters measured by a spirometer and a capnograph.
Detailed description
Patients performing endoscopy procedures under sedation at the gastro clinic will be monitored by SafeSed in addition to being monitored by capnography, used by an anaesthetist. All patients will be monitored using the same two techniques (SafeSed and Capnography). No clinical decisions will be made based upon the data generated by the SafeSed system.
The data from all sources will be compared (post factum) to validate SafeSed performance.
The data collected on the SafeSed prototype will not be used for treatment of the patient.
The comparative analysis will be free vto be used by the sponsor.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled to perform endoscopy procedures under sedation
Key inclusion criteria (2 listed)
- class 1-3 per American Society Anesthesiologists Physical Status Classification
- Subject signed Informed Concent Form
Key exclusion criteria (4 listed)
- Pregnancy
- Unresolved pulmonary infection requiring active treatment
- Chronic pulmonary disease
- Any othe medical condition, that treating physician determines participating in the study is unadvisable
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 |
|---|---|---|
| SafeSedMonitor respiratory parameters | Device | – |
Primary outcome
Comparative data of monitoring respiratory by 2 technologies
Time frame: 4 months
Validation of SafeSed performance by comparing to capnography. The respiratory rate (RR) and end tidal carbon dioxide (ETCO2) levels will be collected into a personal computer, and stored with a continuous time-stamp. RR, tidal volume (TD) and minute ventilatio (MV) calculations using the SafeSed markers chest movements will be stored at the same PC using the same time-stamp. Comparison will show correlation between deterioration events of respiratory parameters. This comparison will be the outcome of off-line analysis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Brian Fredman, MD principal investigator
Israel: Clalit Health bServices
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea, run by Meir Medical Center at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Mar 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Fredman, MD (052-278-5127, fredman.brian@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparative data of monitoring respiratory by 2 technologies (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2018.