- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07623330
Use of TEE Derived Measurement vs Direct Measurement Under General Anesthesia in Assessment of Pressure Gradient in Peri Membranous Ventricular Septal Defect
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Ventricular septal defect is the most common congenital heart defect, occurring in 50% of all children with congenital heart disease (CHD) and in 20% as an isolated lesion.
The peri membranous (also called Para membranous or Cono ventricular) VSD is a communication adjacent to a portion of the membranous septum and the fibrous trigone of the heart, where the, and tricuspid valves are in fibrous continuity. These infracristal defects (below the crista supra- ventricularis) are the most common VSD subtype, accounting for approximately 80% of VSDs.
The ventricular septum can be well imaged by TEE. Starting from the standard transverse plane at 0° or so in the mi esophageal four-chamber (ME 4-Ch) view, the crux of the heart, the inlet septum and most of the muscular trabecular septum can be well seen from the AV valves down to the apex.
In this study, the investigators aim to compare the pressure gradient obtained by transesophageal echocardiography across the restrictive peri membranous VSD with direct catheter-based measurements of such gradient.
During the pre-anesthetic evaluation, demographic variables will be collected from each patient. ASA physical status and relevant comorbidities will be documented, and a recent echocardiogram will confirm the presence of VSD, its size, pressure gradient and estimated PAP.
Patients will be taken to the operating room and monitored with ASA standard monitors: ECG, NIBP, pulse oximetry, and capnography. Preoxygenation will be performed with FiO₂ adjusted to maintain normal oxygen saturation Anesthesia inhalational induction will be performed with sevoflurane until IV access is secured. Once IV access is established, transition to IV agents, fentanyl (1-2 mcg/kg), and rocuronium (0.8 mg/kg). Ventilation with oxygen and sevoflurane 1.5% for 3 min.
Direct laryngoscopy and intubation will be performed by an attending anesthesiologist (with more than two years of experience post-qualification) along with femoral arterial and venous line along with internal jugular central venous line insertion.
Using the previously inserted lines, the pressure gradient across VSD along with RVSP and PASP are directly measured using catheters under guidance of fluoroscopy along with the hemodynamics it was obtained with. This entails that this should be performed in a hybrid theatre otherwise, the confirmation of catheter placement by TEE should be done. TEE inserted in the same setup under the same hemodynamics, RV inflow outflow view obtained with best alignment for CWD interrogation and pressure gradient obtained along with its respective hemodynamics, this step is to be repeated with different personnel with different levels of experience. Care should be taken that both measurements should be taken with the same hemodynamics. TEE measurements of pressure gradient across the VSD are to be measured in the ME five chamber view and ME aorta long axis view as well.
The surgeon will then perform median sternotomy, cpb cannulation, VSD repair. Any considerable events during weaning from cpb shall be recorded along with the doses needed for vasopressors and inotropic support. TEE post bypass will be done by senior attending confirming VSD closure, RV function and PAP if possible.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: karim mohammad el kersh, MBBCH
- Numéro de téléphone: 01002123494
- E-mail: karim.elkersh@med.asu.edu.eg
Lieux d'étude
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Abbasia
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Cairo, Abbasia, Egypte, 00202
- Ain Shams
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Contact:
- karim mohammad el kersh, MBBCH
- Numéro de téléphone: 01002123494
- E-mail: karim.elkersh@med.asu.edu.eg
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
The study will include pediatric patients aged 6 months to 5 years diagnosed with isolated peri membranous ventricular septal defect (VSD) who are scheduled for elective surgical VSD closure under general anesthesia. All patients will undergo intraoperative assessment of the pressure gradient across the VSD using both transesophageal echocardiography (TEE)-derived measurements and direct intraoperative measurement techniques.
Patients with other types of VSD, unrestrictive VSD, associated pulmonary vascular disease, recent or active upper respiratory tract infection, or any relative or absolute contraindication to TEE will be excluded. Informed consent will be obtained from legal guardians prior to enrollment.
La description
Inclusion Criteria:
- Pediatric patients (6 months to 5 years).
- Patients with isolated peri-membranous VSD.
- Scheduled for surgical VSD closure.
Exclusion Criteria:
- Refusal of legal guardians.
- Patients with other types of VSD.
- Patients with pulmonary vascular diseases.
- Patients with unrestrictive VSD.
- Recent or active upper respiratory tract infection.
- Any relative or absolute contraindication for TEE.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
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TEE derived measurement vs direct catheter measurement
Pediatric patients with isolated peri membranous VSD undergoing surgical closure will undergo intraoperative pressure gradient assessment using both TEE-derived and direct catheter-based measurements under general anesthesia
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Accuracy of TEE-derived pressure gradient measurement across peri membranous VSD
Délai: intraoperative
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Accuracy of TEE derived Pressure gradient in numerical value across peri membranous VSD (in Rv inflow outflow view) in comparison with direct catheter-based measurements under general anesthesia.
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intraoperative
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Accuracy of TEE-derived RVSP and PASP measurements
Délai: intraoperative
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Comparison between TEE-derived RVSP/PASP and direct catheter-based measurements under general anesthesia.
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intraoperative
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Interrater agreement of TEE measurements
Délai: intraoperative
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Assessment of agreement between different operators with different levels of experience regarding TEE image acquisition and TEE derived measurements.
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intraoperative
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- FMASU MD358/2025
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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