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CompletedNCT03279172IOPUpdated Sep 13, 2017

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

An interventional study of direct laryngoscope and videolaryngoscope in Intraocular Pressure and Intubation;Difficult, sponsored by Diskapi Teaching and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-13.

Sponsored by Diskapi Teaching and Research Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Intraocular Pressure
  • Intubation;Difficult

Keywords

  • videolaryngoscope
  • intraocular pressure
  • Direct laryngoscope
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Elective Surgery under general anaesthesia

Exclusion criteria

Exclusion Criteria:

  • History of Glaucoma
  • History of hearth disease
  • History of Alzheimer
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
78 participants (actual)

Study arms

  • 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: 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: videolaryngoscope

Interventions

  • Proceduredirect laryngoscope

    procedure entubatıon

  • Procedurevideolaryngoscope
05

What researchers measure

Primary outcomes

  1. High intraorbital pressure

    IOP 18-22 mmHg

    Time frame: 1 minute

06

Study locations

1 site
  • University of Health Dıskapı Yıldırım Beyazıt Training and Hospital
    Ankara, Altındag 06100, Turkey
07

References and documents

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. PubMed 22042705 ↗
  • 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. PubMed 27833500 ↗
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Registry details

Key details

Study ID
NCT03279172
Lead sponsor
Diskapi Teaching and Research Hospital
Responsible party
Ceyda Ozhan Caparlar (Principle investigator, Clinical Specialist of anesthesiology, Diskapi Teaching and Research Hospital) — Principal investigator
First posted
Sep 12, 2017
Start date
Jan 1, 2017
Primary completion
Aug 3, 2017
Completion
Aug 4, 2017
Last update
Sep 13, 2017

Study contacts

Ceyda Ozhan Caparlar
study director · University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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