SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation

Sponsor
Masimo Corporation (Industry)
Overall Status
Terminated
CT.gov ID
NCT03128931
Collaborator
(none)
45
1
1
23.2
1.9

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
  • Device: Pediatric SedLine forehead EEG sensor
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation
Actual Study Start Date :
Dec 23, 2016
Actual Primary Completion Date :
Nov 29, 2018
Actual Study Completion Date :
Nov 29, 2018

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

  1. 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

Ages Eligible for Study:
12 Months to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Responsible Party:
Masimo Corporation
ClinicalTrials.gov Identifier:
NCT03128931
Other Study ID Numbers:
  • HAMM0001
First Posted:
Apr 25, 2017
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes

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

1. Primary Outcome
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

[Not Specified]

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
Email clinicalresearchdept@masimo.com
Responsible Party:
Masimo Corporation
ClinicalTrials.gov Identifier:
NCT03128931
Other Study ID Numbers:
  • HAMM0001
First Posted:
Apr 25, 2017
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022