- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03279172
A Comparison of Videolaryngoscope and Direct Laryngoscope in IOP Changes, Throat Pain, IT and Hemodynamic Variables (IOP)
A Comparison of Videolaryngoscope and Direct Laryngoscope in Intraocular Pressure Changes, Throat Pain, Intubation Time and Hemodynamic Variables
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
INTRODUCTION Videolaryngoscopes are the new generation devices which were introduced into the difficult intubation algorithm by the American Society of Anaesthesiologists (ASA) in 2013 (1). Videolaryngoscopes are known to be superior to traditional direct laryngoscopy in cases of difficult airway, glottic visualisation is obtained more easily and less airway trauma is seen (2). Portable videolaryngoscope which is used in difficult airways (3). There are 2, 3, and 4 numbered blades. In the light source of the blade of the videolaryngoscope, there is a camera which is connected to a video screen monitor. In addition to passing soft tissues by visualisation, the camera is helpful in defining the glottic appearance (1).
There are studies which have compared the hemodynamic response and increase in IOP in intubation using direct laryngoscope and various videolaryngoscopes and airway devices . However, to the best of our knowledge there is no study comparing the effect on the increase in IOP of videolaryngoscope and direct laryngoscope. The aim of the current study was to compare IOP, hemodynamic parameters and throat pain in the use of videolaryngoscope and the direct laryngoscope.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Altındag
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Ankara, Altındag, Turkey, 06100
- University of Health Dıskapı Yıldırım Beyazıt Training and Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Elective Surgery under general anaesthesia
Exclusion Criteria:
- History of Glaucoma
- History of hearth disease
- History of Alzheimer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group Direct Laryngoscope
direct laryngoscope (macintosh laryngoscope) is used in elective surgeries with maximal duration time for two hours.
Standard anaesthesia was used on group and BIS monitorisation was applied.
A record was made of IOP, hemodynamic changes and oxygen saturation at 3 and 10 minutes after intubation.
Throat pain was evaluated by questioning the patient at 10 minutes and 24 hours after waking from general anaesthesia.
The duration of intubation was recorded as the time from the laryngoscope entering the mouth to removal with end-tidal carbon dioxide on the monitor.
Macintosh laryingoscope, BIS monitoring and tonometry would be used in Group Direct Laryngoscope.
|
procedure entubatıon
|
Experimental: Group videolaryngoscope
Videolaryngoscope is used in elective surgeries with maximal duration time for two hours.
Standard anaesthesia was used on group and BIS monitorisation was applied.
A record was made of IOP, hemodynamic changes and oxygen saturation at 3 and 10 minutes after intubation.
Throat pain was evaluated by questioning the patient at 10 minutes and 24 hours after waking from general anaesthesia.
The duration of intubation was recorded as the time from the laryngoscope entering the mouth to removal with end-tidal carbon dioxide on the monitor.
Video laryingoscope, BIS monitoring and tonometry would be used in Group Video Laryngoscope.
|
procedure entubatıon
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
High intraorbital pressure
Time Frame: 1 minute
|
IOP 18-22 mmHg
|
1 minute
|
Collaborators and Investigators
Investigators
- Study Director: Ceyda Ozhan Caparlar, University of Health Dıskapı Yıldırım Beyazıt Training and Hospital
Publications and helpful links
General Publications
- Griesdale DE, Liu D, McKinney J, Choi PT. Glidescope(R) video-laryngoscopy versus direct laryngoscopy for endotracheal intubation: a systematic review and meta-analysis. Can J Anaesth. 2012 Jan;59(1):41-52. doi: 10.1007/s12630-011-9620-5. Epub 2011 Nov 1.
- Vinayagam S, Dhanger S, Tilak P, Gnanasekar R. C-MAC(R) video laryngoscope with D-BLADE and Frova introducer for awake intubation in a patient with parapharyngeal mass. Saudi J Anaesth. 2016 Oct-Dec;10(4):471-473. doi: 10.4103/1658-354X.179118.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22051012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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