Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06142149
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2023-11-15
Brief Title:
The Optimal Endotracheal Tube Cuff Position in Pediatric Patients
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Ultrasound Versus Palpation to Find Optimal Endotracheal Tube Cuff Position in Pediatric Patients Receiving Head and Neck Surgery Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-11
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:
A The hypothesis of this study is Airway ultrasound will be superior to the conventional methods of auscultation and palpation in confirming proper positioning of the endotracheal tube in children undergoing endotracheal intubation with an endotracheal tube with cuff
B The purpose of this study is to determine the utility of airway ultrasound in confirming proper positioning of the endotracheal tube
C In addition we would like to suggest what criteria should be used when using airway ultrasound to determine the fixed position of an endotracheal tube
B The purpose of this study is to determine the utility of airway ultrasound in confirming proper positioning of the endotracheal tube
C In addition we would like to suggest what criteria should be used when using airway ultrasound to determine the fixed position of an endotracheal tube
Detailed Description:
1 Obtain consent from the guardian of the target patient before surgery and perform randomization
2 After entering the operating room attach equipment for electrocardiogram non-invasive blood pressure peripheral oxygen saturation anesthesia depth monitoring and neuromuscular blockade monitoring
3 Prepare the endotracheal tube according to the patients age 6 months to 18 months internal diameter 35 18 months to 2 years internal diameter 35 or 40 2-4 years internal diameter 40 4 to 5 years internal diameter 45 5 years and older Age4 35
4 When sufficient neuromuscular blockade is achieved after infusion of neuromuscular blocking agents after inserting the endotracheal tube check the position of the endotracheal tube according to the assigned group fix the endotracheal tube in consideration of changes in posture during surgery and record its depth
Ultrasound group A During tracheal intubation using a video laryngoscope the endotracheal tube is stopped when the endotracheal tube cuff passes through the vocal cord
B Use ultrasound to check the position of the endotracheal tube cuff check its movement according to the surgical position and position the cuff according to the size of the endotracheal tube as follows
internal diameter 35 internal diameter 40 The cuff is positioned 05 cm below the lower margin of the cricoid cartilage
internal diameter 45 internal diameter 50 The cuff is positioned 1 cm below the lower margin of the cricoid cartilage
C In the final position check for bilateral lung movement lung sliding sign using lung ultrasound
D Record the depth of fixation of the endotracheal tube
Conventional Group A During tracheal intubation with video laryngoscope stop the endotracheal tube when the cuff of the endotracheal tube passes through the vocal cords and confirm that the cuff of the endotracheal tube is palpable at the suprasternal notch
B Adjust the position of the endotracheal tube to account for movement in the surgical position and confirm that the endotracheal tube cuff is palpable at the suprasternal notch in the final position for surgery
C Confirm that bilateral lung sounds are audible through auscultation and secure the endotracheal tube
D Record the depth of endotracheal tube placement
5 After the end of surgery and before awakening the patient check the position of the endotracheal tube cuff using ultrasound
Record how far the proximal margin of the endotracheal tube cuff is from the lower margin of the cricoid and how it relates to surrounding structures 1st tracheal ring 2nd tracheal ring 3rd tracheal ring below the 3rd tracheal ring above the cricoid level
Check the movement of both lungs sliding sign using lung ultrasound
2 After entering the operating room attach equipment for electrocardiogram non-invasive blood pressure peripheral oxygen saturation anesthesia depth monitoring and neuromuscular blockade monitoring
3 Prepare the endotracheal tube according to the patients age 6 months to 18 months internal diameter 35 18 months to 2 years internal diameter 35 or 40 2-4 years internal diameter 40 4 to 5 years internal diameter 45 5 years and older Age4 35
4 When sufficient neuromuscular blockade is achieved after infusion of neuromuscular blocking agents after inserting the endotracheal tube check the position of the endotracheal tube according to the assigned group fix the endotracheal tube in consideration of changes in posture during surgery and record its depth
Ultrasound group A During tracheal intubation using a video laryngoscope the endotracheal tube is stopped when the endotracheal tube cuff passes through the vocal cord
B Use ultrasound to check the position of the endotracheal tube cuff check its movement according to the surgical position and position the cuff according to the size of the endotracheal tube as follows
internal diameter 35 internal diameter 40 The cuff is positioned 05 cm below the lower margin of the cricoid cartilage
internal diameter 45 internal diameter 50 The cuff is positioned 1 cm below the lower margin of the cricoid cartilage
C In the final position check for bilateral lung movement lung sliding sign using lung ultrasound
D Record the depth of fixation of the endotracheal tube
Conventional Group A During tracheal intubation with video laryngoscope stop the endotracheal tube when the cuff of the endotracheal tube passes through the vocal cords and confirm that the cuff of the endotracheal tube is palpable at the suprasternal notch
B Adjust the position of the endotracheal tube to account for movement in the surgical position and confirm that the endotracheal tube cuff is palpable at the suprasternal notch in the final position for surgery
C Confirm that bilateral lung sounds are audible through auscultation and secure the endotracheal tube
D Record the depth of endotracheal tube placement
5 After the end of surgery and before awakening the patient check the position of the endotracheal tube cuff using ultrasound
Record how far the proximal margin of the endotracheal tube cuff is from the lower margin of the cricoid and how it relates to surrounding structures 1st tracheal ring 2nd tracheal ring 3rd tracheal ring below the 3rd tracheal ring above the cricoid level
Check the movement of both lungs sliding sign using lung ultrasound
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