An Endotracheal Tube Inserted to the Level of the Hypopharynx

NCT06449924 | Completed

• 1 other identifier: BIO-2024-0114
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess the incidence of successful ventilation using an ETT inserted orally above the vocal cords in pediatric patients undergoing surgeries. The main question it aims to answer are: Is the use of an endotracheal tube (ETT), positioned in the hypopharynx with its tip placed just above the vocal cords an easy, safe and effective way for the ventilation of pediatric patients who are undergoing surgery under general anesthesia via orotracheal intubation? The procedures to be performed in this study are standard of care. They are also used by pediatric anesthesiologists in the oral intubation of pediatric patients suffering from tumor or abscess.

Conditions

Intubation; Difficult or Failed; Pediatric ALL; Ventilator Lung

Outcome Measures

Primary Outcomes (1)

• Successful ventilation

  Successful ventilation which is evaluated according to the following criteria: Delivery of tidal volume that makes the chest rise visibly, a stable value of SpO2, and at least eight end tidal CO2 waveforms.

  During intubation

Secondary Outcomes (2)

• Incidence of severe hypoxemia

  During intubation

• Incidence of adverse events

  During intubation

Interventions

Endotracheal tube DEVICE

Endotracheal Tube Inserted to the Level of the Hypopharynx

Eligibility Criteria

• Age: 1 Month - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants and children who are \> 1 month and ≤ 6 years old undergoing surgeries at the American University of Beirut Medical Center (AUBMC).

You may qualify if:

• Age \> 1 month and ≤ 6 years
• Legal guardian/representative willing to sign consent

You may not qualify if:

• Existing endotracheal tube
• BMI \> 30 kg/m2
• Patient with a risk of aspiration of history of GERD
• Inability or unwillingness of research participant's legal guardian/ representative to give consent
• Need for emergency surgery
• ASA Ⅲ-Ⅳ

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Roland Kaddoum, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 10, 2024
• Study Start: June 21, 2024
• Primary Completion: August 22, 2025
• Study Completion: August 22, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)