Head Position on Pediatric Nasotracheal Intubation

Not Applicable

Completed

• Conditions: Intubation
• Interventions: Other: Head position

• Registration Number: NCT05164276
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-20
• Study Start: 2022-05-18
• Primary Completion: 2023-09-06
• Study Completion: 2023-09-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexed group	Head position	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).
Sniffing group	Head position	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).
Neutral group	Head position	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).

Primary Outcome Measures

Name	Time	Method
Intubation time	Within 5 minutes	The time between entry of the nasotracheal tube into a nostril and appearance of a carbon dioxide wave on the monitor.

Secondary Outcome Measures

Name	Time	Method
Epistaxis score	When removing the video-laryngoscope	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)
Numeric rating scale of intubation difficulty	During intubation	Subjective intubation difficulty from 0 (easiest) to 10 (most difficult)
Intubation difficulty scale	During intubation	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)

Trial Locations

Locations (1)

Ajou University School of Medicine; 🇰🇷 Suwon, Gyeong-gi, Korea, Republic of