Head Position on Pediatric Nasotracheal Intubation

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

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

Study Overview

• Status: Completed
• Conditions: Intubation
• Intervention / Treatment: Other: Head position

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeong-gi
    • Suwon, Gyeong-gi, Korea, Republic of
      • Ajou University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sniffing group; Before intubation, the patient's shoulder is supported by a 5cm pillow to make neck flexion with extension of atlanto-occipital joint, confirming that the external auditory meatus and sternal notch plane are horizontal and aligned. Then, nasotracheal intubation is performed with a reinforced tube (Mallinckrodt Medical, Dublin, Ireland) using video-laryngoscope (AceScope, AceMedical, Seoul, Korea).	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.
Experimental: Neutral group; Before intubation, the patient's head is placed without a pillow on the bed. Then, nasotracheal intubation is performed with a reinforced tube (Mallinckrodt Medical, Dublin, Ireland) using video-laryngoscope (AceScope, AceMedical, Seoul, Korea).	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.
Experimental: Flexed group; Before intubation, the patient's neck is flexed with pads until the chin touches the chest. Then, nasotracheal intubation is performed with a reinforced tube (Mallinckrodt Medical, Dublin, Ireland) using video-laryngoscope (AceScope, AceMedical, Seoul, Korea).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Numeric rating scale of intubation difficulty	Subjective intubation difficulty from 0 (easiest) to 10 (most difficult)	During intubation

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2022
• Primary Completion (Actual): September 6, 2023
• Study Completion (Actual): September 6, 2023

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 20, 2021

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AJIRB-MED-INT-21-432

Drug and device information, study documents

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