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

Primary Purpose

Congenital Heart Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pediatric cardiac surgery
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Heart Disease focused on measuring retrograde autologous priming pulmonary mechanics

Eligibility Criteria

12 Months - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • cyanotic heart disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Retrograde priming

    conventional priming

    Arm Description

    retrograde autologous Blood Priming of Cardiopulmonary Bypass (RAP) in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.

    conventional cardiopulmonary priming in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.

    Outcomes

    Primary Outcome Measures

    Comparison of postoperative peak air way pressure between the studied groups
    peak air way pressure (Paw) in cmH2O
    Comparison of postoperative air way resistance between the studied groups
    air way resistance (Raw) in cmH2O/L/sec.
    Comparison of postoperative Plateau pressure between the studied groups
    Plateau pressure in cm H2O
    Comparison of postoperative Lung compliance between the studied groups
    Lung compliance in L/cm H2O
    Comparison of postoperative Tidal volume between the studied groups
    Tidal volume in ml

    Secondary Outcome Measures

    Full Information

    First Posted
    February 1, 2020
    Last Updated
    March 3, 2020
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04260204
    Brief Title
    Effect of Retrograde Autologous Blood Priming on Pulmonary Mechanics in Pediatric Cardiac Surgery
    Acronym
    RAPCPB
    Official Title
    Effect of Retrograde Autologous Blood Priming of Cardiopulmonary Bypass on Hemodynamic Parameters and Pulmonary Mechanics in Pediatric Cardiac Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2, 2015 (Actual)
    Primary Completion Date
    December 30, 2019 (Actual)
    Study Completion Date
    January 25, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Congenital Heart Disease
    Keywords
    retrograde autologous priming pulmonary mechanics

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients were included in the study if they had left to right shunt due to volume or pressure overload
    Masking
    ParticipantInvestigator
    Masking Description
    double-blind masking
    Allocation
    Randomized
    Enrollment
    124 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Retrograde priming
    Arm Type
    Active Comparator
    Arm Description
    retrograde autologous Blood Priming of Cardiopulmonary Bypass (RAP) in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.
    Arm Title
    conventional priming
    Arm Type
    Active Comparator
    Arm Description
    conventional cardiopulmonary priming in young children subjected to cardiac surgery for congenital heart defects with left to right shunt associated with volume or pressure overload.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pediatric cardiac surgery
    Primary Outcome Measure Information:
    Title
    Comparison of postoperative peak air way pressure between the studied groups
    Description
    peak air way pressure (Paw) in cmH2O
    Time Frame
    1 hour after surgery
    Title
    Comparison of postoperative air way resistance between the studied groups
    Description
    air way resistance (Raw) in cmH2O/L/sec.
    Time Frame
    1 hour after surgery
    Title
    Comparison of postoperative Plateau pressure between the studied groups
    Description
    Plateau pressure in cm H2O
    Time Frame
    1 hour after surgery
    Title
    Comparison of postoperative Lung compliance between the studied groups
    Description
    Lung compliance in L/cm H2O
    Time Frame
    1 hour after surgery
    Title
    Comparison of postoperative Tidal volume between the studied groups
    Description
    Tidal volume in ml
    Time Frame
    1 hour after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Months
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: children complained of congenital heart disease with left to right shunt pressure or volume load Exclusion Criteria: cyanotic heart disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hamdy Singab, PhD
    Organizational Affiliation
    Ain shams university faculty of medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Pulmonary mechanics improvement in pediatric patients undergoing cardiac surgery with retrograde autologous priming
    IPD Sharing Time Frame
    6 months
    IPD Sharing Access Criteria
    Pediatric cardiac surgeon

    Learn more about this trial

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

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