: External Shunt Versus Internal Shunt for Off Pump Glenn

Cerebral Ischemia Clinical Trial

Official title:

External Shunt Versus Internal Shunt for Off Pump Glenn (Original Article)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294718
• Other study ID #: MS-103-2013
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: August 1, 2022

Study information

• Verified date: March 2023
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia
• Ischemia

Intervention

Procedure:
• Internal shunt
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.
• External 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

Locations

Country	Name	City	State
Egypt	Kasr Alainy hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean SVC Pressure	Measurment of superior vena cava pressure during off pumb Glenn	during SVC clamping procedure
Secondary	mean ABP	Measurment of mean arterial blood preassure during off bumb Glenn	"baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention
Secondary	cerebral perfusion pressure	CPP= MABP - CVP	"baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention
Secondary	Mean SVC clamp time	Duration of SVC during off pump glenn with either Internal or external shunt	during SVC clamping procedure