NCT02634099

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
19 days until next milestone

Study Start

First participant enrolled

January 5, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2016

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

December 8, 2015

Last Update Submit

August 6, 2018

Conditions

Child

Keywords

major pediatric surgeryhemoglobin measurement

Outcome Measures

Primary Outcomes (1)

  • comparison of hemoglobin measurement using 3 different techniques at the time of transfusion decision

    comparison of blood hemoglobin obtained by arterial samples with 2 non invasive methods of measurement using hemocue and SpHb

    within the day of surgery

Study Arms (1)

hemoglobine monitoring

OTHER

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

Device: blood measurementDevice: pulse co-oxymeter (SpHb)Device: hemoCue

Interventions

blood measurementDEVICE

Hemoglobin measurement

hemoglobine monitoring
pulse co-oxymeter (SpHb)DEVICE

non invasive method of hemoglobin measurement

hemoglobine monitoring
hemoCueDEVICE

non invasive method of hemoglobin measurement

hemoglobine monitoring

Eligibility Criteria

Age1 Month - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Hemoglobin disease Pretreatment with erytropoietin or iron

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chru Nancy

Vandœuvre-lès-Nancy, France

Location

Study Officials

  • Claude MEISTELMAN, MD

    CHRU NANCY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2015

First Posted

December 17, 2015

Study Start

January 5, 2016

Primary Completion

November 23, 2016

Study Completion

November 23, 2016

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

FR(1)