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

• Sponsor: Diskapi Teaching and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03279172
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Arms: 2
• Actual Duration (Months): 7.1
• Patients Per Site Per Month: 11

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• 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: Jan 1, 2017
• Actual Primary Completion Date: Aug 3, 2017
• Actual Study Completion Date: Aug 4, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. High intraorbital pressure [1 minute]

   IOP 18-22 mmHg

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Elective Surgery under general anaesthesia

Exclusion Criteria:

• History of Glaucoma

• History of hearth disease

• History of Alzheimer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Health Dıskapı Yıldırım Beyazıt Training and Hospital	Ankara	Altındag	Turkey	06100

Sponsors and Collaborators

• Diskapi Teaching and Research Hospital

Investigators

• Study Director: Ceyda Ozhan Caparlar, University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• Griesdale DE, Liu D, McKinney J, Choi PT. Glidescope® 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. Review.

• 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: Sep 12, 2017
• Last Update Posted: Sep 13, 2017
• Last Verified: Sep 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ceyda Ozhan Caparlar, Principle investigator, Clinical Specialist of anesthesiology, Diskapi Teaching and Research Hospital: videolaryngoscope; intraocular pressure; Direct laryngoscope

Study Results

No Results Posted as of Sep 13, 2017