Clinical trial NCT06449924: An Endotracheal Tube Inserted to the Level of the Hypopharynx
Official 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intubation; Difficult or Failed
Pediatric ALL
Ventilator Lung
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 98
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and children under 6 years of age who undergo surgeries at the American University of Beirut Medical Center (AUBMC).

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 comparing the rate of successful ventilation between attending anesthesiologist and residents, assessing the incidence of success at first attempt, incidence of severe hypoxemia (SPO2 less than 85%), and incidence of adverse events such as bradycardia, stomach insufflation, laryngospasm, and desaturation.

Methods: This prospective observational study will include infants and children under 6 years of age who undergo surgeries at the American University of Beirut Medical Center (AUBMC). The tube will be inserted orally above the vocal cords following which ventilation will be attempted. The exclusion criteria include pediatric patients with an existing endotracheal tube, a BMI \> 30 kg/m2, a risk of aspiration or a history of gastroesophageal reflux disease (GERD), and those undergoing emergency surgeries or whose legal guardian/representative is unwilling/unable to provide an written consent. The primary outcome is to assess successful ventilation (chest rise, end tidal CO2 wave and SpO2 levels).

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.

Eligibility criteria: Inclusion Criteria:

* Infants and children under 6 years of age undergoing surgery
* Legal guardian/representative willing to sign consent

Exclusion Criteria:

* 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
* Neonates below 28 days of age

Primary outcomes:
measure: Successful ventilation
timeFrame: During intubation
Secondary outcomes:
measure: Rate of successful ventilation for attendings compared to that for residents
timeFrame: During intubation
measure: Incidence of success at first attempt
timeFrame: During intubation
measure: Incidence of severe hypoxemia
timeFrame: During intubation
measure: Incidence of adverse events
timeFrame: During intubation
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Roland Kaddoum, MD
role: PRINCIPAL_INVESTIGATOR
References: