Effect of Retrograde Autologous Blood Priming on Pulmonary Mechanics in Pediatric Cardiac Surgery

Congenital Heart Disease Clinical Trial

— RAPCPB  

Official title:

Effect of Retrograde Autologous Blood Priming of Cardiopulmonary Bypass on Hemodynamic Parameters and Pulmonary Mechanics in Pediatric Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04260204
• Other study ID #: ACTS004367
• Status: Completed
• Phase: N/A
• Start date: January 2, 2015
• Est. completion date: January 25, 2020

Study information

• Verified date: March 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study hypothesized that beyond its hemodynamic affects,retrograde autologus blood priming of cardiopulmonary bypass (RAP) has a positive impact on hemodynamics and pulmonary mechanics subjected to cardiac surgery.

Description:

This prospective randomized study analyzed the clinical records of 124 children subjected to cardiac surgery for congenital heart diseases with left to right shunt. They comprised 64 patients with RAP and 60 patients conventional cardiopulmonary bypass priming. The preoperative, intraoperative and postoperative data of the studied patients were reported.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 25, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 5 Years

Eligibility

Inclusion Criteria:

• children complained of congenital heart disease with left to right shunt pressure or volume load

Exclusion Criteria:

• cyanotic heart disease

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases

Intervention

Procedure:
• Pediatric cardiac surgery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of postoperative peak air way pressure between the studied groups	peak air way pressure (Paw) in cmH2O	1 hour after surgery
Primary	Comparison of postoperative air way resistance between the studied groups	air way resistance (Raw) in cmH2O/L/sec.	1 hour after surgery
Primary	Comparison of postoperative Plateau pressure between the studied groups	Plateau pressure in cm H2O	1 hour after surgery
Primary	Comparison of postoperative Lung compliance between the studied groups	Lung compliance in L/cm H2O	1 hour after surgery
Primary	Comparison of postoperative Tidal volume between the studied groups	Tidal volume in ml	1 hour after surgery