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Completed

NCT Number: NCT05164276

Head Position on Pediatric Nasotracheal Intubation

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

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Key information

Conditions

Intubation

Age range

2 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Head position

Other

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

Primary outcomes

  1. Intubation time

    Time frame: 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 outcomes

  1. Intubation difficulty scale

    Time frame: 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)

  2. Epistaxis score

    Time frame: 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)

  3. Numeric rating scale of intubation difficulty

    Time frame: During intubation

    Subjective intubation difficulty from 0 (easiest) to 10 (most difficult)

Sponsors and collaborators

Lead sponsor

Ajou University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2021
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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