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

Heart Defects, Congenital Clinical Trial

Official 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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02498626
• Other study ID #: IRB000087110
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2015
• Last updated: February 1, 2016
• Start date: December 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital

Intervention

Other:
• venous saturations
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.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes