Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06449924
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-04
Brief Title:
An Endotracheal Tube Inserted to the Level of the Hypopharynx
Sponsor:
American University of Beirut Medical Center
Organization:
American University of Beirut Medical Center
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 kgm2 a risk of aspiration or a history of gastroesophageal reflux disease GERD and those undergoing emergency surgeries or whose legal guardianrepresentative is unwillingunable 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
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 kgm2 a risk of aspiration or a history of gastroesophageal reflux disease GERD and those undergoing emergency surgeries or whose legal guardianrepresentative is unwillingunable 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None