NCT05495880

Brief Summary

The purpose of this study is to determine whether the forearm-supported head extension decreases dental contact between laryngoscope blade and maxillary incisors during direct laryngoscopy

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Status
unknown

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

August 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

May 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 12, 2023

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

August 8, 2022

Last Update Submit

May 10, 2023

Conditions

Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • Dental contact

    Dental contact between laryngoscope blade and maxillary incisors (Y/N)

    during laryngoscopy

Secondary Outcomes (2)

  • Blade-to-tooth distance

    during laryngoscopy

  • Angle of head extension

    during laryngoscopy

Study Arms (2)

Forearm-supported

EXPERIMENTAL

forearm-supported head extension during direct laryngoscopy

Procedure: Laryngoscopy with forearm-support

Control

ACTIVE COMPARATOR

without forearm-support for head extension during direct laryngoscopy

Procedure: Laryngoscopy without forearm-support

Interventions

Laryngoscopy with forearm-supportPROCEDURE

forearm-supported head extension during direct laryngoscopy

Forearm-supported
Laryngoscopy without forearm-supportPROCEDURE

without forearm-support for head extension during direct laryngoscopy

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing surgery that require endotracheal intubation for general anesthesia

You may not qualify if:

  • Trauma or disease or cervical spine
  • Toothless patient
  • Dentoalveolar injury
  • Anatomical anomaly of face or airway
  • History of difficult intubation
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Song SE, Ju JW, Park JY, Park D, Yoon S, Nam K, Lee HJ, Seo JH, Kim WH, Bahk JH. Forearm support to reduce dental contact during direct laryngoscopy: a randomized crossover trial. Can J Anaesth. 2025 Oct;72(10):1511-1520. doi: 10.1007/s12630-025-03035-w. Epub 2025 Oct 13.

    PMID: 41083757DERIVED

MeSH Terms

Interventions

Laryngoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeOtorhinolaryngologic Surgical Procedures

Central Study Contacts

Jae-Hyon Bahk, MD PhD

CONTACT

82-2-2072-2818bahkjh@snu.ac.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2022

First Posted

August 10, 2022

Study Start

May 18, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 12, 2023

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share