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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06449924
Enrollment
85
Registered
2024-06-10
Start date
2024-06-21
Completion date
2025-08-22
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation; Difficult or Failed, Pediatric ALL, Ventilator Lung

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.

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.

Interventions

DEVICEEndotracheal tube

Endotracheal Tube Inserted to the Level of the Hypopharynx

Sponsors

American University of Beirut Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Months to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Successful ventilationDuring intubationSuccessful 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

MeasureTime frameDescription
Incidence of severe hypoxemiaDuring intubationIncidence of severe hypoxemia (SPO2 less than 85%)
Incidence of adverse eventsDuring intubationIncidence of adverse events such as bradycardia, stomach insufflation, and laryngospasm

Countries

Lebanon

Contacts

PRINCIPAL_INVESTIGATORRoland Kaddoum, MD

American University of Beirut Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 24, 2026