: External Shunt Versus Internal Shunt for Off Pump Glenn

NCT05294718 | Completed DMC

• 1 other identifier: MS-103-2013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Ischemia

Outcome Measures

Primary Outcomes (1)

• Mean SVC Pressure

  Measurment of superior vena cava pressure during off pumb Glenn

  during SVC clamping procedure

Secondary Outcomes (3)

• mean ABP

  "baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention

• cerebral perfusion pressure

  "baseline, pre-intervention" "during the intervention procedure" "immediately after the intervention

• Mean SVC clamp time

  during SVC clamping procedure

Study Arms (2)

Internal shunt

ACTIVE COMPARATOR

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.

Procedure: Internal shunt

External shunt

ACTIVE COMPARATOR

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

Procedure: External shunt

Interventions

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.

Also known as: Venoatrial shunt

Internal 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

Also known as: Jagulo femoral shunt

External shunt

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.-

You may not qualify if:

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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Brain Ischemia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: concealed in opaque closed envelops
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, ICU and Pain managment

Model Details: A prospective, randomized comparative study

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 24, 2022
• Study Start: June 1, 2017
• Primary Completion: May 1, 2022
• Study Completion: August 1, 2022
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

EG (1)