Comparison of the Macintosh, King Vision®, Glidescope® and AirTraq® Laryngoscopes in Routine Airway Management

NCT01914523 | Completed Phase 1 DMC

• 1 other identifier: KFHU-FBR 0039
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

Failure to successfully intubate the trachea and secure the airway remains a leading cause of morbidity and mortality, in the operative \[1-2\] and emergency settings. \[3-4\]. When the concept of endotracheal intubation was developed, 100 years ago the procedure was performed blindly. Shortly thereafter, laryngoscopes were invented, allowing for direct visualization of the larynx with a viewing angle of 15 degrees \[5\]. Insufficient laryngoscopic view constitutes the main reason for difficult intubations \[6\]. Video laryngoscopes provide an improved view of the glottis, as the camera is a few millimeters away from the glottis. The use of Glidescope \[7-8\] and AirTraq \[9\] laryngoscopes has superior glottis view and ease of tracheal intubation compared with the traditional Macintosh laryngoscope. Unfortunately, the use video laryngoscopes is associated with longer time to tracheal intubation compared with the traditional techniques which be explained with the variable learning curves of the practitioners. \[10\] The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical, Indianapolis, Indiana, USA) is a relative newcomer to the video laryngoscopes of devices that claim to provide the "perfect view" for intubation via use of video and digital technology. The King Vision Video laryngoscope is a two piece design. It has a reusable monitor that attaches to disposable blades. Blades are made of high quality poly-carbonate plastic and house a complementary semi-conductor (CMOS) micro camera offers a 160 degree of view and LED light source. Up to best of the authors' knowledge, there is no current published or ongoing randomized controlled comparative study of the use of King Vision laryngoscope with traditional laryngoscope and other video laryngoscopes for endotracheal intubation.

Conditions

Patients Need Tracheal Intubation

Keywords

Laryngoscope; Macintosh; Glidescope; King Vision; AirTraq; tracheal intubation

Outcome Measures

Primary Outcomes (1)

• Time to tracheal intubation

  the time when the investigated laryngoscope passes the central incisors to the time when the tip of the tracheal tube passed through the glottis

  participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds

Secondary Outcomes (6)

• laryngoscopic view

  participants will be followed for the duration of laryngeal exposure, an expected average of 90 seconds

• ease of intubation

  participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds

• number of intubation attempts

  participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds

• number of optimization maneuvers

  participants will be followed for the duration of tracheal intubation, an expected average of 60 seconds

• duration of laryngoscopy

  during laryngoscopy

Study Arms (4)

Macintosh

PLACEBO COMPARATOR

tracheal intubation will be performed using a Macintosh

Device: Macintosh

King Vision

ACTIVE COMPARATOR

tracheal intubation will be performed using a King Vision

Device: King Vision

Glidescope

ACTIVE COMPARATOR

tracheal intubation will be performed using a Glidescope

Device: Glidescope

AirTraq

ACTIVE COMPARATOR

tracheal intubation will be performed using a AirTraq

Device: AirTraq

Interventions

Macintosh DEVICE

Laryngeal exposure and tracheal intubation using that device

Macintosh

King Vision DEVICE

Laryngeal exposure and tracheal intubation using that device

King Vision

Glidescope DEVICE

Laryngeal exposure and tracheal intubation using that device

Glidescope

AirTraq DEVICE

Laryngeal exposure and tracheal intubation using that device

AirTraq

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status class I-II
• aged 18-65 years
• scheduled for elective surgery
• under general anesthesia

You may not qualify if:

• Expected or known difficult airway
• history of cervical spine injury
• history of cervical spine surgery
• previous throat surgery
• previous oral surgery
• gastro-esophageal reflux disease
• pregnancy
• need for rapid sequence induction
• emergent surgery
• body mass index higher than 35 kg/m2
• Missing incisor teeth
• Unstable hypertension
• Unstable coronary artery disease
• Asthma
• Cerbrovascular disease

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (2)

Dammam University

Khobar, Eastern Province, 31259, Saudi Arabia

Location

King Fahd Hospital of the University

Khobar, Eastern Province, 31952, Saudi Arabia

Location

Study Officials

• Abdulmohsen Al Ghamdi, MD

  Associate Professor/Chairman of Anesthesiology

  PRINCIPAL INVESTIGATOR

• Mohamed R El Tahan, MD

  Associate Professor of Anesthesiology

  STUDY DIRECTOR

• Alaa M Khidr, MD

  Assistant Professor of Anesthesiology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2013
• First Posted: August 2, 2013
• Study Start: September 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

SA (2)