NCT04291326

Brief Summary

Little is known about how implementation of pneumoperitoneum contributes to cerebral blood flow in pediatrics. We investigated this question in patients undergoing laparoscopic surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

March 20, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2021

Completed
Last Updated

March 16, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

February 28, 2020

Last Update Submit

March 15, 2021

Conditions

Cerebral Blood Flow

Outcome Measures

Primary Outcomes (1)

  • Cerebral blood flow

    cerebral blood flow measurement using transfontanelle ultrasound

    intraoperative

Interventions

Transfontanelle ultrasoundDIAGNOSTIC_TEST

cerebral blood flow measurement using transfontanelle ultrasound

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients undergoing general anesthesia for laparoscopic surgery

You may qualify if:

  • pediatric patients undergoing laparoscopic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 2, 2020

Study Start

March 20, 2020

Primary Completion

December 28, 2021

Study Completion

December 28, 2021

Last Updated

March 16, 2021

Record last verified: 2021-03

Locations

KR(1)