NCT05164276

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

May 18, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2023

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

December 6, 2021

Last Update Submit

July 23, 2024

Conditions

Intubation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Intubation difficulty scale

    During intubation

  • Epistaxis score

    When removing the video-laryngoscope

  • Numeric rating scale of intubation difficulty

    During intubation

Study Arms (3)

Sniffing group

ACTIVE COMPARATOR

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

Neutral group

EXPERIMENTAL

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

Flexed group

EXPERIMENTAL

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

Interventions

Head positionOTHER

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

Flexed groupNeutral groupSniffing group

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 2-8 years old
  • Amerian Society of Anesthesiologists I or II
  • Patients who need nasotracheal intubation for surgery

You may not qualify if:

  • A recent airway infection within 14 days
  • Anatomical deformity in head and neck
  • Modified Mallampati score IV
  • Bleeding tendency in preoperative laboratory examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ajou University School of Medicine

Suwon, Gyeonggi-do, South Korea

Location

MeSH Terms

Interventions

Head-Down Tilt

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 6, 2021

First Posted

December 20, 2021

Study Start

May 18, 2022

Primary Completion

September 6, 2023

Study Completion

September 6, 2023

Last Updated

July 25, 2024

Record last verified: 2024-07

Locations

KR(1)