The Optimal Endotracheal Tube Cuff Position in Pediatric Patients

Ultrasound Versus Palpation to Find Optimal Endotracheal Tube Cuff Position in Pediatric Patients Receiving Head and Neck Surgery: Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Intubation
• Intervention / Treatment: Procedure: ultrasonographic evaluation

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 patient's age. 6 months to 18 months: internal diameter 3.5 18 months to 2 years: internal diameter 3.5 or 4.0 2-4 years: internal diameter 4.0 4 to 5 years: internal diameter 4.5 5 years and older: Age/4 + 3.5

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 3.5, internal diameter 4.0: The cuff is positioned 0.5 cm below the lower margin of the cricoid cartilage.
   • internal diameter 4.5, internal diameter 5.0: 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 Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eun-Hee Kim, M.D., Ph.D.; Phone Number: +82-2-2072-3664; Email: beloveun@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Children's Hospital
    • Contact: Eun-Hee Kim, M.D., Ph.D.; Phone Number: +82-2-2072-3664; Email: beloveun@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pediatric patients ages 6 months to 7 years who are scheduled to have an endotracheal tube inserted for facial or intraoral surgery.

Exclusion Criteria:

• When difficult intubation is anticipated
• If the patient has deformities such as facial asymmetry due to congenital causes such as genetic diseases or acquired causes such as accidents.
• If the patient or guardian does not agree to participate in the study.
• Other cases deemed unsuitable by the researcher

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultrasound group; 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.	Procedure: ultrasonographic evaluation; Screen the front of neck using ultrasound
No Intervention: Conventional group; Adjust the position of the endotracheal tube to account for movement in the surgical position and confirm that the endotracheal tube air sac is palpable at the suprasternal notch in the final position for surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of the patients whose cuff is optimally located.	Percentage of patients with endotracheal tube cuff located below the cricoid lower margin and at a depth that allows movement of both lungs, as confirmed by postoperative ultrasound.	at the end of the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences in final endotracheal tube fixation depth in the two groups	difference between tube fixation depth (cm)	at the end of induction of anesthesia
Incidence of respiratory events	endobronchial intubation, incidental extubation, laryngospasm, bronchospasm, desaturation, airway obstruction, stridor	throughout the surgery
proportion of final cuff position	Above cricoid / 1st ring / 2nd ring / 3rd ring / below 3rd ring of trachea	at the end of the surgery
incidence of postoperative complication	laryngospasm, bronchospasm, desaturation, airway obstruction, stridor, severe coughing	at postanesthetic care unit

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Eun-Hee Kim, M.D., Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 20, 2023
• First Posted (Actual): November 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2308-112-1459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Limited availability to those deemed appropriate by the researcher.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No