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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Successful ventilation
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Month to 6 Years (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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
- Rate of successful ventilation for attendings compared to that for residents(During intubation)
- Incidence of success at first attempt(During intubation)
- Incidence of severe hypoxemia(During intubation)
- Incidence of adverse events(During intubation)
Investigators
Roland Kaddoum
Principal Investigator
American University of Beirut Medical Center