Preoperative Noninvasive Hemoglobin Monitoring in Pediatric Patients

• Conditions: Surgery
• Interventions: Other: No treatment

• Registration Number: NCT02484365
• Lead Sponsor: Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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.

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-29
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18
• Primary Completion: 2018-12
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

• ASA class 1,2

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
single arm study	No treatment	No treatment or intervention will given to the patients

Primary Outcome Measures

Name	Time	Method
hemoglobin	once, preoperative visit anesthetic office	no F/U is needed

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine : Chung-Aung University Hospital; 🇰🇷 Seoul, Korea, Republic of