The Optimal Endotracheal Tube Cuff Position in Pediatric Patients

NCT06142149 | Unknown

• 1 other identifier: 2308-112-1459
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Differences in final endotracheal tube fixation depth in the two groups

  at the end of induction of anesthesia

• Incidence of respiratory events

  throughout the surgery

• proportion of final cuff position

  at the end of the surgery

• incidence of postoperative complication

  at postanesthetic care unit

Study Arms (2)

Ultrasound group

EXPERIMENTAL

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

Conventional group

NO INTERVENTION

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.

Interventions

ultrasonographic evaluation PROCEDURE

Screen the front of neck using ultrasound

Ultrasound group

Eligibility Criteria

• Age: 6 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Children's Hospital

Seoul, 03080, South Korea

RECRUITING

Study Officials

• Eun-Hee Kim, M.D., Ph.D.

  Seoul National University Hospital

  STUDY CHAIR

Central Study Contacts

Eun-Hee Kim, M.D., Ph.D.

CONTACT

+82-2-2072-3664; beloveun@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 21, 2023
• Study Start: November 16, 2023
• Primary Completion: July 31, 2024
• Study Completion: March 31, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)