Mcgrath Videolaryngoscope Versus Macintosh Laryngoscope in Patients With Manual In-line Stabilization

Comparison of the Mcgrath Videolaryngoscope With the Macintosh Laryngoscope for Orotracheal Intubation in Patients With Manual In-line Stabilization

Video laryngoscopy provides easily a good laryngeal view compared to direct laryngoscopy. It is particularly, useful in patients with anticipated difficult intubation, and also widely used for educational purposes. Among video laryngoscopy, Mcgrath is a recently-developed, portable video laryngoscopy with a liquid crystal display (LCD) monitor and disposable curved blade.

Mcgrath is known to provide excellent laryngeal visibility even in case of anticipated-difficult and anticipated-unsuccessful intubation as well as normal airway management. However, compared with direct laryngoscopy, the success rate of intubation and the time required for anticipated difficult intubation have been reported conflicting results in previous studies. The aim of this study was to compare the intubation success rate, the intubation time and the ease of use with Mcgrath video laryngoscopy and direct laryngoscopy during intubation.

Study Overview

• Status: Unknown
• Conditions: Anesthesia, General
• Intervention / Treatment: Device: Group ML; Device: Group DL

Detailed Description

1. In the operating room, all patients are monitored with an electrocardiograph, noninvasive blood pressure, pulse oximeter, capnograph and Bispectral index (BIS) monitor. After pre-oxygenation with 100% oxygen for 1 minute, intravenous anesthesia (TIVA) with propofol and remifentanyl is administrated and followed by rocuronium (0.6mg/kg). When patients are lost their consciousness, manual mask ventilation is proceeded with 100% oxygen for 2 minutes.
2. Transoral endotracheal intubation is performed using Mcgrath videolaryngoscope (Group ML) and direct laryngoscope (Group DL) using manual in-line stabilization. At this time, the time required for intubation is measure by other medical personnel not engaged in this research.
3. The anesthesiologist assesses Cormack Lehane laryngeal visual field,external laryngeal manipulation, intubation difficulty scales (IDS) and the difficulty of intubation.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Anyang, Gyeonggi-do, Korea, Republic of, 14068
      • Recruiting
      • Hallym University Sacred Heart Hospital
      • Contact: Yi Hwa Choi, Dr; Phone Number: 3946 82-31-380-3813; Email: pcyhchoi@hallym.or.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients scheduled for general anesthesia requiring tracheal intubation. Patients are aged 19 to 70 years and are American Society of Anesthesiologists physical status I, II.

Exclusion Criteria:

• Patients requiring rapid sequence intubation Patients with poor teeth or high risk of aspiration pneumonia Cervical spine pathology, pharyngeal pathology

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group ML; Mcgrath videolaryngoscopy	Device: Group ML; Mcgrath videolaryngoscope
Active Comparator: Group DL; direct Macintosh laryngoscope	Device: Group DL; Macintosh laryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation success rate	success or failure of intubation	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required for intubation	time until end tidal carbon dioxide (CO2) measurement after laryngeal blade passing through patient's teeth	1 hour
Intubation difficulty score	difficulty at the time of intubation. (easy /moderate/ difficult)	1 hour
Complications	oral bleeding, teeth or lip bleeding	1 day

Collaborators and Investigators

• Sponsor: Hallym University Medical Center
• Investigators: Study Director: Yi Hwa Choi, Dr, Halllym university Sacred Hospital

Publications and helpful links

General Publications

• Rai MR, Dering A, Verghese C. The Glidescope system: a clinical assessment of performance. Anaesthesia. 2005 Jan;60(1):60-4. doi: 10.1111/j.1365-2044.2004.04013.x.
• Asai T, Murao K, Shingu K. Training method of applying pressure on the neck for laryngoscopy: use of a videolaryngoscope. Anaesthesia. 2003 Jun;58(6):602-3. doi: 10.1046/j.1365-2044.2003.03207_7.x. No abstract available.
• Shippey B, Ray D, McKeown D. Case series: the McGrath videolaryngoscope--an initial clinical evaluation. Can J Anaesth. 2007 Apr;54(4):307-13. doi: 10.1007/BF03022777.
• Shippey B, Ray D, McKeown D. Use of the McGrath videolaryngoscope in the management of difficult and failed tracheal intubation. Br J Anaesth. 2008 Jan;100(1):116-9. doi: 10.1093/bja/aem303. Epub 2007 Oct 23.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Anticipated): June 30, 2018
• Study Completion (Anticipated): July 7, 2018

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): May 4, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Videolaryngoscopy
• Other Study ID Numbers: 2017-I043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No