NCT03248830

Brief Summary

The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb) compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart disease. The investigators will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2019

Completed
Last Updated

October 1, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

August 10, 2017

Last Update Submit

September 29, 2019

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • non-invasive hemoglobin

    the value of hemoglobin measured by radical-7 device in g/dL

    5 hours

Secondary Outcomes (8)

  • laboratory hemoglobin

    5 hours

  • perfusion index

    5 hours

  • plethysmography variability index

    5 hours

  • systolic blood pressure

    5 hours

  • diastolic blood pressure

    5 hours

  • +3 more secondary outcomes

Interventions

radical-7 pulse co-oximeterDEVICE

Radical-7 pulse co-oximter will be applied to the patient through a special probe attached the the patient digit to measure blood hemoglobin

Also known as: Masimo pulse co-oximeter

Eligibility Criteria

Age1 Month - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study will include children less than 8 years with congenital hear diseases scheduled for surgery or endo-vascular iintervention

You may qualify if:

  • infants and children less than 8 years
  • with congenital heart disease

You may not qualify if:

  • refusal of the patient surrogate to share in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Ahmed Mukhtar, Professor

    Head of research committee section in anesthesia department

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 14, 2017

Study Start

February 20, 2018

Primary Completion

August 1, 2019

Study Completion

September 10, 2019

Last Updated

October 1, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)