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Completed

NCT Number: NCT05294718

: External Shunt Versus Internal Shunt for Off Pump Glenn

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.

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Key information

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Alainy hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internal shunt

Procedure

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.

Other names: Venoatrial shunt

External shunt

Procedure

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

Other names: Jagulo femoral shunt

Primary outcomes

  1. Mean SVC Pressure

    Time frame: during SVC clamping procedure

    Measurment of superior vena cava pressure during off pumb Glenn

Secondary outcomes

  1. mean ABP

    Time frame: "baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention

    Measurment of mean arterial blood preassure during off bumb Glenn

  2. cerebral perfusion pressure

    Time frame: "baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention

    CPP= MABP - CVP

  3. Mean SVC clamp time

    Time frame: during SVC clamping procedure

    Duration of SVC during off pump glenn with either Internal or external shunt

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Mar 24, 2022
Registry last updated
Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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