Head Positions for Endotracheal Intubation Using a Videolaryngoscope

Sponsor

SMG-SNU Boramae Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05128968

Collaborator

(none)

180

Enrollment

Location

Arms

12.9

Anticipated Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Endotracheal Intubation	Procedure: endotracheal intubation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

Impact of Head Positions on Endotracheal Intubation Using a Videolaryngoscope

Actual Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Simple extension After induction of anesthesia, endotracheal intubation was performed in simple extension without a pillow using a McGrath MAC videolaryngoscope.	Procedure: endotracheal intubation Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope with a blade for normal or difficult airways
Experimental: Head lift After induction of anesthesia, endotracheal intubation was performed in a head lift position with a pillow using a McGrath MAC videolaryngoscope.	Procedure: endotracheal intubation Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope with a blade for normal or difficult airways
Experimental: Sniffing position After induction of anesthesia, endotracheal intubation was performed in a sniffing position using a McGrath MAC videolaryngoscope.	Procedure: endotracheal intubation Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope with a blade for normal or difficult airways

Arm

Intervention/Treatment

Experimental: Simple extension

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

Procedure: endotracheal intubation

Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope with a blade for normal or difficult airways

Experimental: Head lift

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

Procedure: endotracheal intubation

Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope with a blade for normal or difficult airways

Experimental: Sniffing position

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

Procedure: endotracheal intubation

Endotracheal intubation is performed in simple head extension or sniffing position using a McGrath MAC videolaryngoscope with a blade for normal or difficult airways

Outcome Measures

Primary Outcome Measures

Intubation time [Procedure (During endotracheal intubation)]
The time taken for endotracheal intubation is recorded.

Secondary Outcome Measures

Percentage of glottic opening (POGO) score [Procedure (During endotracheal intubation)]
POGO score is recorded during endotracheal intubation (0%: no visualization of glottic opening; 100%: entire visualization of the glottic opening).
Number of attempts [Procedure (At the end of endotracheal intubation)]
Number of attempts for endotracheal intubation is recorded.
Ease of intubation [Procedure (During endotracheal 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, Cormack-Lehane grades and so on.
Pharyngeal wall injury [Procedure (During endotracheal intubation)]
Presence of pharyngeal wall injury is observed.
Lifting force for advancing an endotracheal tube into the larynx [Procedure (During endotracheal intubation)]
Requirement for lifting force is recorded during the advancement of the endotracheal tube into the larynx.
Laryngeal pressure for advancing an endotracheal tube into the larynx. [Procedure (During endotracheal intubation)]
Requirement for laryngeal pressure is recorded during the advancement of the endotracheal tube into the larynx.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients scheduled for general anesthesia

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul		Korea, Republic of	156-707

Sponsors and Collaborators

SMG-SNU Boramae Medical Center

Investigators

Principal Investigator: Jin-Young Hwang, PhD., SMG-SNU Boramae Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin-Young Hwang, Professor, SMG-SNU Boramae Medical Center

ClinicalTrials.gov Identifier:

NCT05128968

Other Study ID Numbers:

11-2021

First Posted:

Nov 22, 2021

Last Update Posted:

Mar 23, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 23, 2022