A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients

NCT ID: NCT03624140

Last Updated: 2019-02-27

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

Clinical Phase

NA

Total Enrollment

195 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-31

Study Completion Date

2023-05-31

Brief Summary

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Investigators compare the accuracy of the SpHb and hemocue with blood Hb levels

Detailed Description

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The goal of the study is to compare 3 methods of hemoglobin measurement in pediatric patients undergoing major surgery. During general anesthesia investigators will measure and compare at different periods of time blood hemoglobin levels obtained from a radial artery catheter with 2 non invasive methods of measurement using hemocue and SpHb

Conditions

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Child

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blood measurement
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hemoglobin monitoring

3 different techniques will be used for hemoglobine monitoring : hemocue, pulse co-oxymeter (SpHb) and blood measurement

Group Type EXPERIMENTAL

blood measurement

Intervention Type DEVICE

Hemoglobin measurement

pulse co-oxymeter (SpHb)

Intervention Type DEVICE

non invasive method of hemoglobin measurement

hemoCue

Intervention Type DEVICE

non invasive method of hemoglobin measurement

Interventions

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blood measurement

Hemoglobin measurement

Intervention Type DEVICE

pulse co-oxymeter (SpHb)

non invasive method of hemoglobin measurement

Intervention Type DEVICE

hemoCue

non invasive method of hemoglobin measurement

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Paediatric patients scheduled for surgery under general anesthesia
* Arterial catheter necessary in the anesthetic protocol
* BMI\<30
* Written consent of holders of parental authority
* No opposition of children

Exclusion Criteria

\- Hemoglobine disease
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Claude MEISTELMAN, PhD

Role: CONTACT

00 33 3 83 15 41 66

Camille BIENTZ

Role: CONTACT

00 33 6 44 28 96 76

Other Identifiers

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2018-A01379-46

Identifier Type: -

Identifier Source: org_study_id

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