A Comparison of Three Methods of Hemoglobin Monitoring in Pediatric Patients Undergoing Major Surgery

NCT ID: NCT02634099

Last Updated: 2018-08-07

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-05

Study Completion Date

2016-11-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Child

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hemoglobine monitoring

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

Group Type OTHER

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Paediatric patients scheduled for major orthopaedi or neurosurgical process under general anesthesia Arterial catheter necessary in the anesthetic protocol. BMI\<30 No opposition holders of parental authority and children.

Exclusion Criteria

Hemoglobin disease Pretreatment with erytropoietin or iron
Minimum Eligible Age

1 Month

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Claude MEISTELMAN, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU NANCY

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chru Nancy

Vandœuvre-lès-Nancy, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-A00916-43

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.