NCT05128968

Brief Summary

In this study, the investigators evaluate the effect of head positions (simple extension vs. sniffing position vs. head elevation) on endotracheal intubation using a videolaryngoscope.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 22, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2022

Completed
Last Updated

December 29, 2022

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

November 11, 2021

Last Update Submit

December 28, 2022

Conditions

Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • Ease of intubation

    Ease of endotracheal intubation is assessed using the intubation difficulty scale. Intubation difficulty scale includes number of attempts, number of operators, number of alternative techniques, glottic opening and so on.

    Procedure (During endotracheal intubation)

Secondary Outcomes (8)

  • Percentage of glottic opening (POGO) score

    Procedure (During endotracheal intubation)

  • Number of attempts

    Procedure (At the end of endotracheal intubation)

  • Intubation time

    Procedure (During endotracheal intubation)

  • Palatopharyngeal wall injury

    Procedure (During endotracheal intubation)

  • Lifting force for exposure of the glottis

    Procedure (During endotracheal intubation)

  • +3 more secondary outcomes

Study Arms (3)

Simple extension

EXPERIMENTAL

After induction of anesthesia, endotracheal intubation was performed in simple extension without a pillow using a McGrath MAC videolaryngoscope.

Procedure: endotracheal intubation

Head elevated position

EXPERIMENTAL

After induction of anesthesia, endotracheal intubation was performed in a head elevated position with a pillow using a McGrath MAC videolaryngoscope.

Procedure: endotracheal intubation

Sniffing position

EXPERIMENTAL

After induction of anesthesia, endotracheal intubation was performed in a sniffing position using a McGrath MAC videolaryngoscope.

Procedure: endotracheal intubation

Interventions

endotracheal intubationPROCEDURE

Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope.

Head elevated positionSimple extensionSniffing position

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for general anesthesia

You may not qualify if:

  • Limited neck extension
  • Anatomical anomalies or history of surgery in the upper airway
  • Weak teeth
  • Risk of pulmonary aspiration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 156-707, South Korea

Location

Related Publications (1)

  • Kim H, Chang JE, Won D, Lee JM, Kim TK, Kim MJ, Min SW, Hwang JY. Effect of head and neck positions on tracheal intubation using a McGRATH MAC video laryngoscope: A randomised, prospective study. Eur J Anaesthesiol. 2023 Aug 1;40(8):560-567. doi: 10.1097/EJA.0000000000001838. Epub 2023 Apr 13.

    PMID: 37052067DERIVED

MeSH Terms

Interventions

Intubation, Intratracheal

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Jin-Young Hwang, PhD.

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 22, 2021

Study Start

December 1, 2021

Primary Completion

December 9, 2022

Study Completion

December 9, 2022

Last Updated

December 29, 2022

Record last verified: 2022-12

Locations

KR(1)