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A Comparison of Videolaryngoscope and Direct Laryngoscope in IOP Changes, Throat Pain, IT and Hemodynamic Variables (IOP)

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ClinicalTrials.gov Identifier: NCT03279172
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Ceyda Ozhan Caparlar, Diskapi Teaching and Research Hospital

Brief Summary:
The aim of the study was to compare intraocular pressure, intubation time, throat pain and hemodynamic variables using direct or videolaryngoscopy under general anesthesia requiring endotracheal intubation

Condition or disease Intervention/treatment Phase
Intraocular Pressure Intubation;Difficult Procedure: direct laryngoscope Procedure: videolaryngoscope Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: A Comparison of Videolaryngoscope and Direct Laryngoscope in Intraocular Pressure Changes, Throat Pain, Intubation Time and Hemodynamic Variables
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : August 3, 2017
Actual Study Completion Date : August 4, 2017

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: direct laryngoscope
procedure entubatıon

Procedure: videolaryngoscope
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: direct laryngoscope
procedure entubatıon

Procedure: videolaryngoscope



Primary Outcome Measures :
  1. High intraorbital pressure [ Time Frame: 1 minute ]
    IOP 18-22 mmHg



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elective Surgery under general anaesthesia

Exclusion Criteria:

  • History of Glaucoma
  • History of hearth disease
  • History of Alzheimer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279172


Locations
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Turkey
University of Health Dıskapı Yıldırım Beyazıt Training and Hospital
Ankara, Altındag, Turkey, 06100
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
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Study Director: Ceyda Ozhan Caparlar University of Health Dıskapı Yıldırım Beyazıt Training and Hospital
Publications of Results:
Other Publications:
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Responsible Party: Ceyda Ozhan Caparlar, Principle investigator, Clinical Specialist of anesthesiology, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT03279172    
Other Study ID Numbers: 22051012
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ceyda Ozhan Caparlar, Diskapi Teaching and Research Hospital:
videolaryngoscope
intraocular pressure
Direct laryngoscope