Head Position on Pediatric Nasotracheal Intubation

Intubation Clinical Trial

Official title:

Effect of Head Position on Nasotracheal Intubation With Video-laryngoscope in Pediatric Patients: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05164276
• Other study ID #: AJIRB-MED-INT-21-432
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Ajou University School of Medicine
• Contact: Yun Jeong Chae, M.D., Ph.D.
• Phone: 82-102195576
• Email: yjchae06[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of study is to evaluate whether the head position facilitates pediatric nasotracheal intubation when using a video-laryngoscope.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

Inclusion Criteria:

• Age 2-8 years old

• Amerian Society of Anesthesiologists I or II

• Patients who need nasotracheal intubation for surgery

Exclusion Criteria:

• A recent airway infection within 14 days

• Anatomical deformity in head and neck

• Modified Mallampati score IV

• Bleeding tendency in preoperative laboratory examination

Related Conditions & MeSH terms

• Intubation

Intervention

Other:
• Head position
Before nasotracheal intubation, patient's head is positioned to one of three positions according to assigned group: sniffing, neutral or flexed position.

Locations

Country	Name	City	State
Korea, Republic of	Ajou University School of Medicine	Suwon	Gyeong-gi

Sponsors (1)

Lead Sponsor	Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation time	The time between entry of the nasotracheal tube into a nostril and appearance of a carbon dioxide wave on the monitor.	Within 5 minutes
Secondary	Intubation difficulty scale	The sum of score from seven variables including intubation attempts, supplementary operators, the use of alternative techniques, glottic exposure, the lifting force applied during laryngoscopy, the necessity of applied external laryngeal pressure, and position of vocal cords.; From 0 (easiest) to 8 (most difficult)	During intubation
Secondary	Epistaxis score	grade 1 (no-epistaxis), grade 2 (mild, blood on the tube only), grade 3 (moderate, blood pooling in the pharynx), or grade 4 (severe: blood impedes intubation)	When removing the video-laryngoscope
Secondary	Numeric rating scale of intubation difficulty	Subjective intubation difficulty from 0 (easiest) to 10 (most difficult)	During intubation