AnesthesiaNCT03128931
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
A study testing Pediatric SedLine forehead EEG sensor in people with Anesthesia, run by Masimo Corporation at 1 site in United States.
Trial summary
The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation. Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Pediatric SedLine forehead EEG sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2016to 29 Nov 2018
- 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 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients 17 years old and younger
- ASA status I, II, or III.
- Scheduled for surgical and non-surgical procedures scheduled under general anesthesia or sedation (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc. Surgery can be open, laparoscopic, or robotic).
Who cannot join
- Any deformities or devices that may prevent application of SedLine Array to forehead with a proper fit.
- Cases in which a rapid sequence induction is indicated (emergency, full stomach precautions).
- 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
Lucille Packard Children's Hospital
Stanford, California, 94305
About this study
The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation.
- Conditions
- Anesthesia
- Being tested
- Pediatric SedLine forehead EEG sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric SedLine forehead EEG sensorDevice
Pediatric EEG sensor.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor. Receives: Device: Pediatric SedLine forehead EEG sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants For Whom the EEG Data Collection Was Completed
EEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions.
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 posted25 Apr 2017
- Study start23 Dec 2016
- Primary completion29 Nov 2018
- Study completion29 Nov 2018
Why it stopped: Study was terminated as enrollment rate did not meet the requirement of the Sponsor.
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.
- 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
- 45 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
- NCT03128931
- Sponsor's protocol ID
- HAMM0001
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2017
- Last updated
- 7 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
- ClinicalTrials.gov ID
- NCT03128931
- Acronym / sponsor ID
- HAMM0001
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated as enrollment rate did not meet the requirement of the Sponsor.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2016 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 25 Apr 2017 (actual)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Pediatric SedLine forehead EEG sensorThe subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor. |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients 17 years old and younger
- ASA status I, II, or III.
- Scheduled for surgical and non-surgical procedures scheduled under general anesthesia or sedation (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc. Surgery can be open, laparoscopic, or robotic).
Key exclusion criteria (4 listed)
- Any deformities or devices that may prevent application of SedLine Array to forehead with a proper fit.
- Cases in which a rapid sequence induction is indicated (emergency, full stomach precautions).
- 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 |
|---|---|---|
| Pediatric SedLine forehead EEG sensorPediatric EEG sensor. | Device | Test Group |
Primary outcome
Number of Participants For Whom the EEG Data Collection Was Completed
Time frame: Duration of surgery
EEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 Pediatric SedLine forehead EEG sensor 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 3 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: stopped early, as of the sponsor's last update on 7 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 7 Jul 2020). 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?
Number of Participants For Whom the EEG Data Collection Was Completed (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?
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 7 Apr 2022.