SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
Study Details
Study Description
Brief 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Test Group The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor. |
Device: Pediatric SedLine forehead EEG sensor
Pediatric EEG sensor.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants For Whom the EEG Data Collection Was Completed [Duration of surgery]
EEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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).
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Lucille Packard Children's Hospital | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Masimo Corporation
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- HAMM0001
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Test Group |
---|---|
Arm/Group Description | The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor . Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor. |
Period Title: Overall Study | |
STARTED | 45 |
COMPLETED | 41 |
NOT COMPLETED | 4 |
Baseline Characteristics
Arm/Group Title | Test Group |
---|---|
Arm/Group Description | The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor . Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor. |
Overall Participants | 41 |
Age (Count of Participants) | |
<=18 years |
41
100%
|
Between 18 and 65 years |
0
0%
|
>=65 years |
0
0%
|
Sex: Female, Male (Count of Participants) | |
Female |
9
22%
|
Male |
32
78%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
7
17.1%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
3
7.3%
|
White |
25
61%
|
More than one race |
0
0%
|
Unknown or Not Reported |
6
14.6%
|
Region of Enrollment (participants) [Number] | |
United States |
41
100%
|
Outcome Measures
Title | Number of Participants For Whom the EEG Data Collection Was Completed |
---|---|
Description | EEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions. |
Time Frame | Duration of surgery |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Test Group |
---|---|
Arm/Group Description | The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor . Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor. |
Measure Participants | 41 |
Count of Participants [Participants] |
41
100%
|
Adverse Events
Time Frame | 1 day | |
---|---|---|
Adverse Event Reporting Description | ||
Arm/Group Title | Test Group | |
Arm/Group Description | The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor . Pediatric SedLine forehead EEG sensor: Pediatric EEG sensor. | |
All Cause Mortality |
||
Test Group | ||
Affected / at Risk (%) | # Events | |
Total | 0/45 (0%) | |
Serious Adverse Events |
||
Test Group | ||
Affected / at Risk (%) | # Events | |
Total | 0/45 (0%) | |
Other (Not Including Serious) Adverse Events |
||
Test Group | ||
Affected / at Risk (%) | # Events | |
Total | 0/45 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Vikram Ramakanth |
---|---|
Organization | Masimo Corporation |
Phone | 949-297-7416 |
clinicalresearchdept@masimo.com |
- HAMM0001