Comparison of the Videolaryngoscopes With Manual In-line Stabilization

Comparison of the McGrath Videolaryngoscope and the Pentax-AWS With the Macintosh Laryngoscope for Nasotracheal Intubation in Patients With Manual In-line Stabilization

Videolaryngoscope is useful to improve the laryngeal view, especially during difficult intubation. There are several kinds of videolaryngoscopes and it is applicable during nasotracheal intubation. In this study, the investigators will compare the McGrath videolaryngoscope and Pentax-AWS with Macintosh laryngoscope for nasotracheal intubation in patients with manual in-line stabilization.

Study Overview

• Status: Completed
• Conditions: Oral Surgery; Maxillofacial Surgery
• Intervention / Treatment: Procedure: MILS; Device: McGrath videolaryngoscope; Device: Pentax AWS videolaryngoscope; Device: Macintosh laryngoscope

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• oral or maxillofacial surgery
• ASA class I, II

Exclusion Criteria:

• anticipated difficult intubation
• necessity for rapid sequence induction
• cervical spine injury
• bleeding tendency

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: McGrath Group; MgGrath videolaryngoscope will be used for nasotracheal intubation with MILS	Procedure: MILS; MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.; Device: McGrath videolaryngoscope; McGrath videolaryngoscope will be used for intubation
Experimental: Pentax-AWS Group; Pentax-AWS videolaryngoscope will be used for nasotracheal intubation with MILS	Procedure: MILS; MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.; Device: Pentax AWS videolaryngoscope; Pentax AWS videolaryngoscope will be used for intubation
Experimental: Macintosh Laryngoscope Group; Macintosh Laryngoscope will be used for nasotracheal intubation with MILS	Procedure: MILS; MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.; Device: Macintosh laryngoscope; Macintosh laryngoscope will be used for intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time for intubation		from holding the laryngoscope until the 1st ventilation after intubation, within 90 seconds
Cormack Lehane Laryngeal view		when laryngoscope is appropriately placed during intubation, approximately 2 seconds
POGP score	Percentage of glottic opening(POGO)	when laryngoscope is appropriately placed during intubation, approximately 2 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
external laryngeal manipulation	When the laryngeal view is insufficient during laryngoscope, another physician can manipulate the larynx externally to improve the laryngeal view. The necessity of external laryngeal manipulation will be recorded.	when laryngoscope is appropriately placed during intubation, approximately 2 seconds
magill forceps	when the nasotracheal tube can not introduced to vocal cord manually, magill forceps can hold the tube to advance the tube through vocal cord. The necessity of magill forceps during intubation will be recorded	when laryngoscope is appropriately placed during intubation, approximately 5 seconds
IDS (intubation difficulty scale)	IDS score is the sum of the following seven variables: N1: the number of intubation attempts>1 N2: the number of operators. 1 N3: the number of alternative intubation techniques used N4: glottic exposure (Cormack Lehane grade minus 1) N5: Lifting force required during laryngoscopy (0=normal; 1=increased) N6: necessity for external laryngeal pressure (0=not applied; 1=applied) N7: position of the vocal cords at intubation (0=abduction/ not visualized; 1=adduction)	during intubation, approximately 90 seconds
numeric rating scale for intubation	0-10 (0; no difficulty, 10: hardest)	during intubation, approximately 90 seconds
grade of bleeding	After confirmation of successful intubation, Yankauer suction was introduced to access the intraoral bleeding during intubation. Grade is 4 points scale (none/trace/moderate/severe).	10 seconds after completion of intubation

Collaborators and Investigators

• Sponsor: Ajou University School of Medicine
• Investigators: Principal Investigator: Go Un Roh, MD, Ajou University School of Medicine

Publications and helpful links

General Publications

• Roh GU, Kwak HJ, Lee KC, Lee SY, Kim JY. Randomized comparison of McGrath MAC videolaryngoscope, Pentax Airway Scope, and Macintosh direct laryngoscope for nasotracheal intubation in patients with manual in-line stabilization. Can J Anaesth. 2019 Oct;66(10):1213-1220. doi: 10.1007/s12630-019-01409-5. Epub 2019 May 29.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: December 28, 2015
• First Submitted That Met QC Criteria: January 4, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 4, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: AJIRB-MED-DE1-15-334

Plan for Individual participant data (IPD)

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