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Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing

8. mai 2026 oppdatert av: Ain Shams University

Comparison of Age-Based Formula and Ultrasound-Guided Subglottic Diameter Measurement for Endotracheal Tube Sizing in Single Ventricle Patients

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Mohamed Tolba, MD
  • Telefonnummer: 01156622298

Studiesteder

    • Abbasseya
      • Cairo, Abbasseya, Egypt, 00202
        • Rekruttering
        • Ain Shams University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Age-Based Formula Group

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.

Subglottic diameter in mm x 0.8
Aktiv komparator: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Accuracy of ETT size selection
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of post-extubation stridor/croup
Tidsramme: 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
Severity of post-extubation croup
Tidsramme: At 30 minutes, 2 hours, and 24 hours after extubation
Severity of post-extubation croup assessed using the Westley croup score
At 30 minutes, 2 hours, and 24 hours after extubation
Duration of ICU stay related to airway complications
Tidsramme: From ICU admission until ICU discharge, up to 30 days
Length of ICU stay due to airway complications such as post-extubation stridor
From ICU admission until ICU discharge, up to 30 days

Samarbeidspartnere og etterforskere

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2026

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

22. april 2026

Først innsendt som oppfylte QC-kriteriene

8. mai 2026

Først lagt ut (Faktiske)

14. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • FMASU MD353/2025

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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