- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01347151
A Comparison of Cervical Spine Movement During Tracheal Intubation Using the Pentax or the Glidescope
May 3, 2011 updated by: Prince of Songkla University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The primary outcome is the angular displacement of the vertebrae and secondary outcome is the hemodynamic changes after intubation.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Songkhla
-
Hat Yai, Songkhla, Thailand, 90110
- Songklanagarind Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Glide scope
|
|
|
Experimental: Pentax airway scope
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the angular displacement of the vertebrae
Time Frame: 30 seconds
|
during intubation
|
30 seconds
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the hemodynamic changes after intubation.
Time Frame: 15 minutes
|
after intubation
|
15 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nalinee Kovitwanawong, MD, Depatment of Anesthesiology Faculty of Medicine Prince of Songkla University Thailand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Anticipated)
June 1, 2011
Study Completion (Anticipated)
June 1, 2011
Study Registration Dates
First Submitted
May 2, 2011
First Submitted That Met QC Criteria
May 3, 2011
First Posted (Estimate)
May 4, 2011
Study Record Updates
Last Update Posted (Estimate)
May 4, 2011
Last Update Submitted That Met QC Criteria
May 3, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Glide VS Pentax
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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