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: External Shunt Versus Internal Shunt for Off Pump Glenn

Primary Purpose

Cerebral Ischemia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Internal shunt
External shunt
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Ischemia

Eligibility Criteria

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

Inclusion Criteria:

  • single-ventricle lesions,
  • good sized branch pulmonary arteries (Magoon's index > 1.5),
  • PA pressures < 20 mmHg,
  • So2 < 80%,
  • age range from (6 months-5years)
  • weight range from (6-21) kg, -All these patients had adequate atrial septal defects and none of these patients required any intra cardiac repair.-

Exclusion Criteria:

  • previous cardiac operation,
  • known intracranial pathology,
  • neurologic disease
  • craniofacial anomalies.

Sites / Locations

  • Kasr Alainy hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Internal shunt

External shunt

Arm Description

glenn with internal shunt (veno-atrial shunt) where the surgeon established a shunt between distal SVC and the right atrium, Establishing a veno-atrial shunt.

Glenn with external shunt where the anesthesiologist connected the internal Jagular venous cannula which represent the SVC with the main lumen of the femoral cannula which represent the IVC through long venous extension

Outcomes

Primary Outcome Measures

Mean SVC Pressure
Measurment of superior vena cava pressure during off pumb Glenn

Secondary Outcome Measures

mean ABP
Measurment of mean arterial blood preassure during off bumb Glenn
cerebral perfusion pressure
CPP= MABP - CVP
Mean SVC clamp time
Duration of SVC during off pump glenn with either Internal or external shunt

Full Information

First Posted
February 26, 2022
Last Updated
March 10, 2023
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05294718
Brief Title
: External Shunt Versus Internal Shunt for Off Pump Glenn
Official Title
External Shunt Versus Internal Shunt for Off Pump Glenn (Original Article)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

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
A prospective, randomized comparative study where investigators present results of off pump bidirectional Glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping.
Detailed Description
The bidirectional Glenn shunt (BDG) is performed for cyanotic congenital heart defects, with single-ventricle pathology . The BDG is usually performed with cardiopulmonary bypass (CPB) with its associated complications. The conduct of this operation without CPB can be associated with elevation of superior vena caval (SVC) pressure that may lead to neurological damage. However, the safety of performing BDG without CPB reported by many authors but with some decompression techniques of the SVC at the time of clamping Objective: investigators present results of off pump bidirectional Glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping. Design A prospective, randomized comparative study Setting: Single tertiary care cardiac center Participants 30 patients with functional single ventricle who will go off pump bidirectional Glenn. Interventions: The patients will be randomly assigned into two groups: Group I (n = 15), where it will be done with a veno-atrial shunt(internal), and Group II (n = 15), where it will be done with an external shunt. All patients will go a complete neurological examination both preoperatively as well as postoperatively Intraoperative data will be collected and analyzed at the following time points: pre-clamping (post induction), during clamping and after de-clamping of SVC. variables such as arterial oxygen saturation (SaO2), systolic blood pressure (SBP), mean arterial blood pressure (MAP), diastolic blood pressure (DBP), and hematocrit, CVP, SVC pressure, cerebral perfusion pressure (CPP= MAP-CVP), PaO2, PaCO2 and ScvO2 will be analyzed. Postoperatively, the patients will be stabilized in the intensive care unit (ICU) and after monitoring the SVC pressure for 12 h, the internal jugular vein cannula will be removed to prevent any jugular vein thrombosis. The patients will start aspirin (5 mg/kg/day), which will be continued indefinitely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized comparative study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
concealed in opaque closed envelops
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internal shunt
Arm Type
Active Comparator
Arm Description
glenn with internal shunt (veno-atrial shunt) where the surgeon established a shunt between distal SVC and the right atrium, Establishing a veno-atrial shunt.
Arm Title
External shunt
Arm Type
Active Comparator
Arm Description
Glenn with external shunt where the anesthesiologist connected the internal Jagular venous cannula which represent the SVC with the main lumen of the femoral cannula which represent the IVC through long venous extension
Intervention Type
Procedure
Intervention Name(s)
Internal shunt
Other Intervention Name(s)
Venoatrial shunt
Intervention Description
glenn with internal shunt (veno-atrial shunt) where the surgeon established a shunt between distal SVC and the right atrium, Establishing a veno-atrial shunt.
Intervention Type
Procedure
Intervention Name(s)
External shunt
Other Intervention Name(s)
Jagulo femoral shunt
Intervention Description
Glenn with external shunt where the anesthesiologist connected the internal Jagular venous cannula which represent the SVC with the main lumen of the femoral cannula which represent the IVC through long venous extension
Primary Outcome Measure Information:
Title
Mean SVC Pressure
Description
Measurment of superior vena cava pressure during off pumb Glenn
Time Frame
during SVC clamping procedure
Secondary Outcome Measure Information:
Title
mean ABP
Description
Measurment of mean arterial blood preassure during off bumb Glenn
Time Frame
"baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention
Title
cerebral perfusion pressure
Description
CPP= MABP - CVP
Time Frame
"baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention
Title
Mean SVC clamp time
Description
Duration of SVC during off pump glenn with either Internal or external shunt
Time Frame
during SVC clamping procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: single-ventricle lesions, good sized branch pulmonary arteries (Magoon's index > 1.5), PA pressures < 20 mmHg, So2 < 80%, age range from (6 months-5years) weight range from (6-21) kg, -All these patients had adequate atrial septal defects and none of these patients required any intra cardiac repair.- Exclusion Criteria: previous cardiac operation, known intracranial pathology, neurologic disease craniofacial anomalies.
Facility Information:
Facility Name
Kasr Alainy hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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: External Shunt Versus Internal Shunt for Off Pump Glenn

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