Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Ultrasound, Cole's Formula.
- Кому может быть актуально
- Состояния в реестре: Endotracheal Tube Wrongly Placed During Anesthetic Procedure. Базовые параметры: 3 мес. — 8 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing in Single Ventricle Patients
Обзор
To compare the accuracy of ultrasound-guided subglottic diameter measurement versus age-based formulas in determining the optimal endotracheal tube (ETT) size in pediatric patients with single ventricle physiology and reducing post-extubation complications.
Подробное описание
To compare the accuracy of ultrasound-guided subglottic diameter measurement versus age-based formulas in determining optimal ETT size in pediatric patients with single ventricle physiology to avoid post-extubation complications. All legal guardians will provide written informed consent after a full explanation of the study. During the pre-anesthetic evaluation, demographic data, ASA physical status, relevant comorbidities, and a recent echocardiogram confirming single ventricle physiology will be documented. In the operating room, patients will be monitored using standard ASA monitors including ECG, non-invasive blood pressure, pulse oximetry, and capnography, followed by preoxygenation with 100% oxygen. If intravenous access is available, anesthesia will be induced with ketamine, fentanyl, and rocuronium. If IV access is not available, inhalational induction with sevoflurane will be used until IV access is secured, after which fentanyl and rocuronium will be administered. Following induction, ventilation will continue with FiO₂ 100% and sevoflurane 1.5% for 3 minutes.
Patients will be divided into two groups:
Group A (Age-Based Formula):
In neonates and infants under 1 year, a weight-based sizing is used:
* Infants \<1 kg (Preterm): 2.5 mm ETT * Infants 1-2 kg: 3 mm ETT * Infants 2-3 kg (Full Term): 3-3.5 mm ETT * Infants \>3 kg (3 months to 1 year): 3.5-4 mm ETT
In Infants \> 1 year, ETT size will be selected based on the standard formula: Cole's Formula for uncuffed ETT.
ETT ID (mm) = (Age/4) + 4.
Group B (Ultrasound Group):
During mask ventilation, a trained anesthesiologist will perform transverse subglottic diameter measurement using a high-frequency linear ultrasound probe (7-15 MHz). The patient will be positioned supine with mild neck extension. The probe will be placed transversely just below the thyroid cartilage to identify the subglottic airway at the level of the cricoid cartilage. The measured diameter (in mm) will be recorded and used to determine ETT size from the equation:
ETT ID (mm) = Subglottic diameter (mm) × 0.8 To confirm appropriate ETT sizing, all patients will be placed on pressure-controlled mechanical ventilation and a leak test will be performed in both groups. Start with pressure 20-25 cm H₂O, if there is resistance to ETT passage into the trachea or no audible leak or ventilator-detected leak when the lungs are inflated, the tube will be exchanged for one that is 0.5 mm smaller. If a leak is detected, decrease the pressure to 10 cm H₂O. If there's still a detected leak at 10 cm H₂O, the ETT will be exchanged for one that is 0.5 mm larger. If there's no leak at 10 cm H₂O then the ETT is optimal. Tube size will be considered optimal when a tracheal leak is not detected at an inflation pressure between 10-20 cm H₂O with uncuffed tubes.
Вмешательства
- Устройство Ultrasound
Using Ultrasound for accuracy of ETT sizing - Другое Cole's Formula
Subglottic diameter in mm x 0.8
Первичные конечные точки
- Accuracy of ETT size selection [Срок оценки: During endotracheal intubation, immediately after induction of anesthesia and neuromuscular blockade (within 10 minutes after induction)]
Вторичные конечные точки (3)
- Incidence of post-extubation stridor/croup [Срок оценки: From extubation until 24 hours post-extubation]
- Severity of post-extubation croup [Срок оценки: At 30 minutes, 2 hours, and 24 hours after extubation]
- Duration of ICU stay related to airway complications [Срок оценки: From ICU admission until ICU discharge, up to 30 days]
Критерии участия
Критерии включения
- Pediatric patients (3 months to 8 years)
- Patients with single ventricle physiology
- Scheduled for Glenn or Fontan surgery or cardiac catheterization
- Patients with Glenn or Fontan shunt scheduled for surgery
Критерии исключения
- Refusal of legal guardians
- Emergency surgery
- Patients with tracheostomy tubes
- Recent or active upper respiratory tract infection
- Airway anomalies (e.g. Pierre Robin, Treacher Collins)
- ICU stay due to complications other than that of airway
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Египет · 1 центр
- Ain Shams University — Cairo
Идентификаторы
NCT: NCT07586592 · FMASU MD353/2025