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A Comparison of Cervical Spine Movement During Tracheal Intubation Using the Pentax or the Glidescope

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Prince of Songkla University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01347151
First received: May 2, 2011
Last updated: May 3, 2011
Last verified: May 2011
History of Changes
  Purpose

Both Glide scope and Pentax laryngoscope are video laryngoscope that provide the better view with minimal cervical spine movement. This study wants to compare cervical spine movement during intubation when using these two devices. The C-spine motion will be recorded by using fluoroscopic video to measure the angular displacement of the vertebrae.


Condition Intervention
C-spine Movement During Intubation
 Device: The glidescope video laryngoscopy
Device: The Pentax airwayscope

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • the angular displacement of the vertebrae [ Time Frame: 30 seconds ] [ Designated as safety issue: Yes ]
    during intubation


Secondary Outcome Measures:
  • the hemodynamic changes after intubation. [ Time Frame: 15 minutes ] [ Designated as safety issue: Yes ]
    after intubation


Estimated Enrollment: 200
Study Start Date: May 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glide scope Device: The glidescope video laryngoscopy
Experimental: Pentax airway scope Device: The Pentax airwayscope
Other Name: The Pentax airwayscope (Pentax AWS; Pentax, Tokyo, Japan)

Detailed Description:

The primary outcome is the angular displacement of the vertebrae and secondary outcome is the hemodynamic changes after intubation.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-III
  • Age 18-75 years old
  • Elective noncardiac surgery requiring general anesthesia with tracheal intubation

Exclusion Criteria:

  • Gastroesophageal reflux disease
  • Body mass index greater than 35 kg/m2
  • Possibility of pregnancy
  • Previous neck surgery
  • Unstable C-spine/ C-spine abnormality
  • Known difficult airway
  • Suspected difficult airway
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347151

Locations
Thailand
Songklanagarind Hospital
Hat Yai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
Investigators
Principal Investigator: Nalinee Kovitwanawong, MD Depatment of Anesthesiology Faculty of Medicine Prince of Songkla University Thailand
  More Information

No publications provided

Responsible Party: Assistant Professor Nalinee Kovitwanawong, Department of anesthesiology Faculty of Medicine Prince of Songkla University Thailand
ClinicalTrials.gov Identifier: NCT01347151     History of Changes
Other Study ID Numbers: Glide VS Pentax
Study First Received: May 2, 2011
Last Updated: May 3, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
Glide scope
Pentax
C spine movement

ClinicalTrials.gov processed this record on May 19, 2013