Preoperative Noninvasive Hemoglobin Monitoring in Pediatric Patients

NCT ID: NCT02484365

Last Updated: 2018-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

177 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-03-31

Brief Summary

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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

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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.

Conditions

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Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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single arm study

No treatment or intervention will given to the patients

No treatment

Intervention Type OTHER

Attach adhesive probe on thumb or index finger

Interventions

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No treatment

Attach adhesive probe on thumb or index finger

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ASA class 1,2

Exclusion Criteria

* Poor peripheral circulation
* Infection or trauma on the sensor contact region
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Yong-Hee Park

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong-Hee Park

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yong-Hee Park

Role: CONTACT

Facility Contacts

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Yong-Hee Park

Role: primary

References

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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.

Reference Type RESULT
PMID: 23132397 (View on PubMed)

Other Identifiers

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C2014202(1399)

Identifier Type: -

Identifier Source: org_study_id

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