NCT02484365

Brief Summary

The preoperative evaluation including sampling blood in pediatric patients is hard to perform. However, the knowledge of the baseline cell blood count is important to prepare unexpected surgical bleeding etc.. The invasive procedure for blood sampling in small children is often failed and sometimes induces iatrogenic blood loss and parent's complaints. The Pulse Co-oximetry (Masimo) is recently developed device which can provide noninvasive hemoglobin value. However, the accuracy is controversial. There are studies in pediatric patients during surgery and in ICU. However, the comparison for preoperative evaluation is not analysed. Therefore, the investigators want to evaluate the accuracy for preoperative preparation in pediatric patients.

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
177

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Longer than P75 for all trials

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

Study Start

First participant enrolled

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

4 years

First QC Date

March 6, 2015

Last Update Submit

July 16, 2018

Conditions

Surgery

Keywords

HemoglobinsMonitoring, OutpatientPreoperative PeriodPediatrics

Outcome Measures

Primary Outcomes (1)

  • hemoglobin

    no F/U is needed

    once, preoperative visit anesthetic office

Study Arms (1)

single arm study

No treatment or intervention will given to the patients

Other: No treatment

Interventions

No treatmentOTHER

Attach adhesive probe on thumb or index finger

single arm study

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pediatric patients age under 18 years planning to receive elective surgery under general anesthesia people live in South Korea

You may qualify if:

  • ASA class 1,2

You may not qualify if:

  • Poor peripheral circulation
  • Infection or trauma on the sensor contact region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital

Seoul, South Korea

RECRUITING

Related Publications (1)

  • Jung YH, Lee J, Kim HS, Shin SH, Sohn JA, Kim EK, Choi JH. The efficacy of noninvasive hemoglobin measurement by pulse CO-oximetry in neonates. Pediatr Crit Care Med. 2013 Jan;14(1):70-3. doi: 10.1097/PCC.0b013e318260117d.

    PMID: 23132397RESULT

Study Officials

  • Yong-Hee Park

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong-Hee Park

CONTACT

82dada822@naver.com

Study Design

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

Study Record Dates

First Submitted

March 6, 2015

First Posted

June 29, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2018

Study Completion

March 1, 2019

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

KR(1)