An observational study in Intubation; Difficult or Failed, Pediatric ALL and Ventilator Lung, sponsored by American University of Beirut Medical Center. Completed at 1 site in Lebanon. Open to participants aged 1 Month to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by American University of Beirut Medical Center · Observational
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.
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.
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This study's enrollment of 85 is below the median of 120 across 300 observational studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 are open to participants now.
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Infants and children who are > 1 month and ≤ 6 years old undergoing elective surgeries at the American University of Beirut Medical Center (AUBMC).
Exclusion Criteria:
Endotracheal Tube Inserted to the Level of the Hypopharynx
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.
Time frame: During intubation
Incidence of severe hypoxemia
Incidence of severe hypoxemia (SPO2 less than 85%)
Time frame: During intubation
Incidence of adverse events
Incidence of adverse events such as bradycardia, stomach insufflation, and laryngospasm
Time frame: During intubation
Plan to share: No
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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American University of Beirut Medical Center