Preoperative Noninvasive Hemoglobin Monitoring in Pediatric Patients

July 16, 2018 updated by: Yong-Hee Park, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

The Accuracy of the Noninvasive Hemoglobin Monitoring for Preoperative Evaluation for Pediatric Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

There are not enough data comparing the noninvasive hemoglobin and venous hemoglobin in pediatric patients during preoperative period. The investigators will collect the venous sample and the noninvasive hemoglobin data from masimo within 1 hour. Without any additional medication, the patients will visit preanesthetic room and attach the probe of masimo on index finger. The R 20L or R25L will be used based on their weight. The parameter will be stabilized within 2 minutes and the SpHb and perfusion index will be recorded.

Study Type

Observational

Enrollment (Anticipated)

177

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • ASA class 1,2

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
single arm study
No treatment or intervention will given to the patients
Other: No treatment
Attach adhesive probe on thumb or index finger

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemoglobin
Time Frame: once, preoperative visit anesthetic office
no F/U is needed
once, preoperative visit anesthetic office

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Yong-Hee Park, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

March 6, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • C2014202(1399)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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