Videolaryngoscopes for Double Lumen Tube Intubations in Simulated Easy and Difficult Airway

NCT02640196 | Completed DMC

• 1 other identifier: ANESTH-03-15
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesized that the use of the King Vision™ and the Airtraq® VL would reduce the time to DLT intubation compared with the GlideScope® and Macintosh in simulated easy and difficult airways. The investigators have considered to assess the efficacy of each device in manikins before considering to evaluate them in patients undergoing thoracic procedures. Twenty-one staff anaesthesiologists who had limited prior experience in using the VLs for DLT intubation participated in this randomised crossover study. Following a brief demonstration and two practice attempts, participants were volunteered to insert a DLT using the Macintosh, GlideScope®, Airtraq®, and King Vision™ on two high-fidelity easy and difficult airway simulators in a computer-generated randomized sequence. The primary endpoint, time to DLT intubation, as well as, the views obtained at laryngoscopy, ease of intubation, numbers of laryngoscopy attempts and optimisation manoeuvers, and failure to intubation; defined as an attempt took longer than 150 seconds, were recorded.

Conditions

Staff Anaesthesiologists; Limited Experience in Using Videolaryngoscopes

Keywords

Laryngoscope; Macintosh; Glidescope; King Vision; Airtraq; Double Lumen Tube

Outcome Measures

Primary Outcomes (1)

• Time to achieve successful double lumen tube intubation

  defined as the time when the investigated laryngoscope passed the central incisors to when the tip of the bronchial lumen passed through the glottis, as confirmed visually by the operator (in the Macintosh group) or by the investigator, thanks to remote screens (in the VLs groups).

  for 6 min after using each device

Secondary Outcomes (4)

• Best view during laryngoscopy using the classification described by Cormack and Lehane

  for 1 min after laryngoscopy

• Difficulty of intubation using a Visual Analog Scale (VAS)

  for 6 min after using each device

• Number of first-pass success

  for 3 min after using each device

• Number of the required optimisation manoeuvers

  for 6 min after using each device

Study Arms (4)

Macintosh

PLACEBO COMPARATOR

The participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator

Device: Macintosh

GlideScope

PLACEBO COMPARATOR

The participants intubated the easy airway simulator with a double lumen tube using the GlideScope laryngoscope followed with intubating the difficult airway simulator

Device: GlideScope

Airtraq

ACTIVE COMPARATOR

The participants intubated the easy airway simulator with a double lumen tube using the Airtraq laryngoscope followed with intubating the difficult airway simulator

Device: Airtraq

King Vision

ACTIVE COMPARATOR

The participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator

Device: King Vision

Interventions

Macintosh DEVICE

The participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator

Macintosh

GlideScope DEVICE

The participants intubated the easy airway simulator with a double lumen tube using the GlideScope followed with intubating the difficult airway simulator

GlideScope

Airtraq DEVICE

The participants intubated the easy airway simulator with a double lumen tube using the Airtraq followed with intubating the difficult airway simulator

Airtraq

King Vision DEVICE

The participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator

King Vision

Eligibility Criteria

• Age: 23 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Staff anesthesiologists
• Signed consent
• Limited experience in using videolaryngoscopes for inserting double lumen tubes

You may not qualify if:

• Decline to sign the consent
• Non receiving the prior training demonstration
• Non practicing once with each device tested on each simulator scenario

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Study Sites (1)

Dammam University KFHU

Khobar, EP, 31952, Saudi Arabia

Location

Study Officials

• Mohamed R El Tahan, MD

  Anesthesiology Department, Dammam University, Dammam, Saudi Arabia

  PRINCIPAL INVESTIGATOR

• Abdulmohsen A Al Ghamdi, MD

  Anesthesiology Department, Dammam University, Dammam, Saudi Arabia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 28, 2015
• Study Start: March 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 28, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)