Pediatric ALL Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 98 |
Est. completion date | November 1, 2025 |
Est. primary completion date | June 10, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 6 Years |
Eligibility | 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 ?-? - Neonates below 28 days of age |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
American University of Beirut Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful ventilation | Successful ventilation which is evaluated according to the following criteria:
Delivery of tidal volume that makes the chest rise visibly, oxygen saturation by pulse oximeter not less than the value recorded after pre oxygenation and four end tidal CO2 waveforms. |
During intubation | |
Secondary | Rate of successful ventilation for attendings compared to that for residents | Rate of successful ventilation for attendings compared to that for residents | During intubation | |
Secondary | Incidence of success at first attempt | Incidence of success at first attempt | During intubation | |
Secondary | Incidence of severe hypoxemia | Incidence of severe hypoxemia (SPO2 less than 85%) | During intubation | |
Secondary | Incidence of adverse events | Incidence of adverse events such as bradycardia, stomach insufflation, laryngospasm, and desaturation | During intubation |
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