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To estimate the accuracy of transesophageal echocardiography for the measurement of RVOT gradient in TOF repair

A prospective observational study to estimate the validity of transesophageal echocardiography for the measurement of right ventricle outflow tract gradient in tetralogy of Fallot repair under general endotracheal anesthesia and mechanical ventilation - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/059241
Enrollment
32
Registered
2023-10-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Q213- Tetralogy of Fallot

Interventions

Intervention1: NIL: As it is an observational study Control Intervention1: NIL: As it is an observational study

Sponsors

Department of Anaesthesiology and Critical Care, Aligarh Muslim University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Surgery- Intra- cardiac repair for correction of tetralogy of Fallot

Exclusion criteria

Exclusion criteria: Weight less than 5kg Those with TEE probe insertion contraindications like esophageal disease with known stricture, diverticuli, varices, tumor, prior esophageal or stomach surgery or perforated viscus Patients with infective endocarditis or any evidence of infection Patient undergoing other concomitant cardiac surgeries Patient with pulmonary atresia, AV canal defect Patient not giving consent

Design outcomes

Primary

MeasureTime frame
To estimate the validity in terms of correlation and agreement of different post-CPB TEE views (Mid-Esophageal Ascending Aorta short axis, Mid Esophageal RV Outflow, Transgastric RV Outflow view) with invasive-saline-transducer method in the measurement of RVOT gradientTimepoint: RVOT gradient values 5 minutes post cardio-pulmonary bypass by TEE and invasive method (in mmHg)—

Secondary

MeasureTime frame
Validity of pre-CPB TEE under GETA with pre-op TTE and invasive-saline-transducer method Post-op pulmonary regurgitation grade Extubation time Follow-up of RVOT gradient Post-op inotropes by VIS score Length of hospital stay (LOHS) Outcome in terms of 1 month survival Timepoint: RVOT gradient TTE and TEE and invasive method values before bypass (in mmHg) The time of extubation 1 month survival outcome—

Countries

India

Contacts

Public ContactKulsum Alam

Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University

drmanazirathar@gmail.com8077647330

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026