An Endotracheal Tube Inserted to the Level of the Hypopharynx

An Endotracheal Tube Inserted to the Level of the Hypopharynx is an Easy, Safe, and Effective Technique for Ventilation of Pediatric Patients: A Prospective Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Pediatric ALL; Intubation; Difficult or Failed; Ventilator Lung
• Intervention / Treatment: Device: Endotracheal tube

Detailed Description

Background: Tracheal intubation can be challenging in the pediatric age group. The difficult airway algorithm is followed starting with ventilation via a facemask. In cases of difficulties in intubation and ventilation, and especially in neonates and small infants, oxygen desaturation can happen very quickly and can be life threatening. The endotracheal tube (ETT), which is readily available and bypasses the tongue of the patient, can provide a safe and efficient ventilation.

Specific Aim (s): In our study, we aim at assessing the incidence of successful ventilation using an ETT inserted orally above the vocal cords in pediatric patients undergoing surgeries. Secondary objectives include assessing the incidence of severe hypoxemia (SpO2 < 85%) along with other adverse events, such as bradycardia, stomach insufflation, and laryngospasm

Methods: This prospective, observational study will include 85 infants and small children aged > 1 month and ≤ 6 years old, undergoing elective surgery under general anesthesia with orotracheal intubation. The effectiveness and safety of hypopharyngeal ETT ventilation performed by clinical anesthesia (CA) residents will be evaluated. The primary objective of this study is to assess the efficacy of this technique in providing successful ventilation evidenced by visible chest rise, the presence of a sustained end-tidal capnography (EtCO2) waveform, stable oxygen saturation (SpO2) values, and an adequate expired tidal volume. Secondary outcomes include the incidence of severe hypoxemia (SpO2 < 85%), bradycardia, stomach insufflation, and laryngospasm.

Significance: This ETT technique is simple to implement and use, requiring no special training or equipment. This technique can save time by ensuring patients' oxygenation and ventilation.

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful ventilation	Successful ventilation which is evaluated according to the following criteria: Delivery of adequate expired tidal volume, a stable value of SpO2, and at least eight end tidal CO2 waveforms.	During intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe hypoxemia	Incidence of severe hypoxemia (SPO2 less than 85%)	During intubation
Incidence of adverse events	Incidence of adverse events such as bradycardia, stomach insufflation, and laryngospasm	During intubation

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Roland Kaddoum, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2024
• Primary Completion (Actual): August 22, 2025
• Study Completion (Actual): August 22, 2025

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: BIO-2024-0114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No