Forearm-Supported Head Extension to Decrease Dental Contact

Forearm-Supported Head Extension to Decrease Dental Contact Between Laryngoscope Blade and Maxillary Incisors During Direct Laryngoscopy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Endotracheal Intubation
• Intervention / Treatment: Procedure: Laryngoscopy with forearm-support; Procedure: Laryngoscopy without forearm-support

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jae-Hyon Bahk, MD PhD; Phone Number: 82-2-2072-2818; Email: bahkjh@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing surgery that require endotracheal intubation for general anesthesia

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Forearm-supported; forearm-supported head extension during direct laryngoscopy	Procedure: Laryngoscopy with forearm-support; forearm-supported head extension during direct laryngoscopy
Active Comparator: Control; without forearm-support for head extension during direct laryngoscopy	Procedure: Laryngoscopy without forearm-support; without forearm-support for head extension during direct laryngoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental contact	Dental contact between laryngoscope blade and maxillary incisors (Y/N)	during laryngoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blade-to-tooth distance	Teeth distance between laryngoscope blade and maxillary incisors (mm)	during laryngoscopy
Angle of head extension	Angle of head extension during direct laryngoscopy	during laryngoscopy

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 18, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: August 8, 2022
• First Submitted That Met QC Criteria: August 8, 2022
• First Posted (Actual): August 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: JHBahk_novel_intu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No