Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing
Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing in Single Ventricle Patients
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Nouran Nemr, M.B.B.Ch, M.Sc.
- Numéro de téléphone: 01008558583
- E-mail: Nourannemr@med.asu.edu.eg
Sauvegarde des contacts de l'étude
- Nom: Mohamed Tolba, MD
- Numéro de téléphone: 01156622298
Lieux d'étude
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Abbasseya
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Cairo, Abbasseya, Egypte, 00202
- Recrutement
- Ain Shams University
-
Contact:
- Nouran Nemr, M.B.B.Ch, M.Sc.
- Numéro de téléphone: 01008558583
- E-mail: Nourannemr@med.asu.edu.eg
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Age-Based Formula Group
In neonates and infants under 1 year, a weight-based sizing is used:
ETT ID (mm) = (Age/4) + 4. |
Subglottic diameter in mm x 0.8
|
|
Comparateur actif: 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 |
Using Ultrasound for accuracy of ETT sizing
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Accuracy of ETT size selection
Délai: During endotracheal intubation, immediately after induction of anesthesia and neuromuscular blockade (within 10 minutes after induction)
|
Accuracy of endotracheal tube size selection measured by the number of ETT attempts required to achieve an appropriate leak test and successful airway placement.
|
During endotracheal intubation, immediately after induction of anesthesia and neuromuscular blockade (within 10 minutes after induction)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of post-extubation stridor/croup
Délai: From extubation until 24 hours post-extubation
|
Occurrence of post-extubation stridor or croup assessed using the Westley croup score.
|
From extubation until 24 hours post-extubation
|
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Severity of post-extubation croup
Délai: At 30 minutes, 2 hours, and 24 hours after extubation
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Severity of post-extubation croup assessed using the Westley croup score
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At 30 minutes, 2 hours, and 24 hours after extubation
|
|
Duration of ICU stay related to airway complications
Délai: From ICU admission until ICU discharge, up to 30 days
|
Length of ICU stay due to airway complications such as post-extubation stridor
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From ICU admission until ICU discharge, up to 30 days
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- FMASU MD353/2025
Informations sur les médicaments et les dispositifs, documents d'étude
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