NCT02498626

Brief Summary

This study was designed to examine if venous saturations from the central venous line and from the venous side of the heart lung machine are interchangeable or not with mixed venous saturation from the pulmonary artery in children undergoing open heart surgery for correction of various congenital heart defects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

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

Study Start

First participant enrolled

July 1, 2009

Completed
6 years until next milestone

First Submitted

Initial submission to the registry

June 24, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

May 10, 2016

Status Verified

February 1, 2016

Enrollment Period

6.5 years

First QC Date

June 24, 2015

Last Update Submit

May 7, 2016

Conditions

Heart Defects, Congenital

Keywords

mixed venous saturationopen heart surgerychildren

Outcome Measures

Primary Outcomes (1)

  • Bland and Altman Analysis was used to plot the difference in mixed oxygen saturation

    The agreement between these samples from the central venous line, venous side of the heart lung machine and from the pulmonary artery were done using bland and Altman Analysis

    intraoperative

Study Arms (1)

venous saturations

venous saturations from the central venous line, venous side of the heart lung machine and from the pulmonary artery

Other: venous saturations

Interventions

venous saturationsOTHER

Samples of venous saturations from the central venous line (CVP), from venous side of the heart lung machine and from the pulmonary artery were taken at 10 min after being on CPB and after correction of the cardiac defects.

venous saturations

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

cardiac surgery for children with congenital heart defects

You may qualify if:

  • Children in the age from 1-15 years undergoing correction for congenital heart defects with cardiopulmonary bypass

You may not qualify if:

  • Any chest renal or hepatic problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

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

Study Officials

  • sayed abd elshafy, MD

    associate professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor (Anesthesiology and Critical Care)- College of Medicine

Study Record Dates

First Submitted

June 24, 2015

First Posted

July 15, 2015

Study Start

July 1, 2009

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

May 10, 2016

Record last verified: 2016-02

Locations

EG(1)