AnesthesiaNCT03865316
Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
A study testing SedLine Vs Comparator Test Group in people with Anesthesia, run by Masimo Corporation at 1 site in United States.
Trial summary
The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia
- What is being tested?
- SedLine Vs Comparator Test Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 11 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years old and older at the time of consent.
- ASA status I, II, or III.
- English-speaking subjects.
- Scheduled for surgical and non-surgical procedures scheduled under general anesthesia (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc.).
Who cannot join
- Any deformities or devices that may prevent application of EEG Sensor to forehead with a proper fit.
- Subjects who are developmentally delayed.
- Subjects deemed not suitable for study at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared.
- Conditions
- Anesthesia
- Being tested
- SedLine Vs Comparator Test Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SedLine Vs Comparator Test GroupDevice
Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
| Study group | Role | What they receive |
|---|---|---|
| SedLine Vs Comparator Test Group | Experimental | Not described Receives: Device: SedLine Vs Comparator Test Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Sedation Indices Performance Across Anesthesia Range
The correlation was computed using 1 min average values between the PSi and the comparator's sedation index.
Measured: Duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2019
- Study start25 Jan 2019
- Primary completion11 Mar 2021
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865316
- Sponsor's protocol ID
- APPL0009
- Status last verified
- Mar 2022
- First submitted
- 4 Feb 2019
- Last updated
- 11 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Jones JH, Nittur VR, Fleming N, Applegate RL 2nd. Simultaneous comparison of depth of sedation performance between SedLine and BIS during general anesthesia using custom passive interface hardware: study protocol for a prospective, non-blinded, non-randomized trial. BMC Anesthesiol. 2021 Apr 6;21(1):105. doi: 10.1186/s12871-021-01326-5.
PubMed 33823811
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
- ClinicalTrials.gov ID
- NCT03865316
- Acronym / sponsor ID
- APPL0009
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 6 Mar 2019 (actual)
- Results
- Posted 11 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SedLine Vs Comparator Test Group | Experimental | Device: SedLine Vs Comparator Test Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 18 years old and older at the time of consent.
- ASA status I, II, or III.
- English-speaking subjects.
- Scheduled for surgical and non-surgical procedures scheduled under general anesthesia (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc.).
Key exclusion criteria (3 listed)
- Any deformities or devices that may prevent application of EEG Sensor to forehead with a proper fit.
- Subjects who are developmentally delayed.
- Subjects deemed not suitable for study at the discretion of the investigator.
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 |
|---|---|---|
| SedLine Vs Comparator Test GroupSubjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system. | Device | SedLine Vs Comparator Test Group |
Primary outcome
Correlation of Sedation Indices Performance Across Anesthesia Range
Time frame: Duration of surgery
The correlation was computed using 1 min average values between the PSi and the comparator's sedation index.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33823811Jones JH, Nittur VR, Fleming N, Applegate RL 2nd. Simultaneous comparison of depth of sedation performance between SedLine and BIS during general anesthesia using custom passive interface hardware: study protocol for a prospective, non-blinded, non-randomized trial. BMC Anesthesiol. 2021 Apr 6;21(1):105. doi: 10.1186/s12871-021-01326-5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SedLine Vs Comparator Test Group in people with Anesthesia, run by Masimo Corporation at 1 site in United States.
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 4 inclusion and 3 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 11 Apr 2022. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Correlation of Sedation Indices Performance Across Anesthesia Range (time frame: Duration of surgery). 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 NCT03865316, which also lists 1 linked publication.
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 11 Apr 2022.