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NCT Number: NCT06449924

An Endotracheal Tube Inserted to the Level of the Hypopharynx

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.

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Key information

Conditions

Intubation; Difficult or Failed Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pediatric ALL Precursor Cell Lymphoblastic Leukemia-Lymphoma Ventilator Lung

Age range

1 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

American University of Beirut Medical Center

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endotracheal tube

Device

Endotracheal Tube Inserted to the Level of the Hypopharynx

Primary outcomes

  1. Successful ventilation

    Time frame: During intubation

    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.

Secondary outcomes

  1. Incidence of severe hypoxemia

    Time frame: During intubation

    Incidence of severe hypoxemia (SPO2 less than 85%)

  2. Incidence of adverse events

    Time frame: During intubation

    Incidence of adverse events such as bradycardia, stomach insufflation, and laryngospasm

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2024
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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