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Head Position on Pediatric Nasotracheal Intubation

Sponsor
Ajou University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05164276
Collaborator
(none)
108
Enrollment
1
Location
3
Arms
19.4
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Head position
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Effect of Head Position on Nasotracheal Intubation With Video-laryngoscope in Pediatric Patients: A Randomized Controlled Trial
Actual Study Start Date :
May 18, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

  2. 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)

  3. Numeric rating scale of intubation difficulty [During intubation]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ajou University School of Medicine Suwon Gyeong-gi Korea, Republic of

Sponsors and Collaborators

  • Ajou University School of Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
yun jeong chae, Professor, Ajou University School of Medicine
ClinicalTrials.gov Identifier:
NCT05164276
Other Study ID Numbers:
  • AJIRB-MED-INT-21-432
First Posted:
Dec 20, 2021
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 26, 2022