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Completed

NCT Number: NCT02498626

Mixed Venous Oxygen Saturation From Central Venous Line, Venous Side of Heart Lung Machine and the Pulmonary Artery

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.

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Key information

Conditions

Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Diseases

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine

Asyut, Asyut Governorate, Egypt

About this study

Forty children aged from 1-15 years undergoing correction for different congenital heart procedures with cardiopulmonary bypass [CPB] were included in this study. Simultaneous samples were taken from the central venous line, pulmonary artery, and from venous side of the heart lung machine. Samples were taken after 10 minutes on full CPB and at the end of surgery before end of CPB. Bland and Altman plots were used to study the agreement between venous saturations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any chest renal or hepatic problems

Treatment and study plan

venous saturations

Other

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.

Primary outcomes

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

    Time frame: intraoperative

    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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Are Venous Saturations From the Central Venous Line, Venous Side of the Heart Lung Machine Interchangeable or Not With Mixed Venous Saturation From the Pulmonary Artery in Children Undergoing Open Heart Surgery?

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Jul 15, 2015
Registry last updated
May 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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