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

NCT ID: NCT03279172

Last Updated: 2017-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2017-08-04

Brief Summary

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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

Detailed Description

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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.

Conditions

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Intraocular Pressure Intubation;Difficult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

direct laryngoscope

Intervention Type PROCEDURE

procedure entubatıon

videolaryngoscope

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

direct laryngoscope

Intervention Type PROCEDURE

procedure entubatıon

videolaryngoscope

Intervention Type PROCEDURE

Interventions

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direct laryngoscope

procedure entubatıon

Intervention Type PROCEDURE

videolaryngoscope

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Elective Surgery under general anaesthesia

Exclusion Criteria

* History of Glaucoma
* History of hearth disease
* History of Alzheimer
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ceyda Ozhan Caparlar

Principle investigator, Clinical Specialist of anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ceyda Ozhan Caparlar

Role: STUDY_DIRECTOR

University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

Locations

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University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

Ankara, Altındag, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22042705 (View on PubMed)

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.

Reference Type RESULT
PMID: 27833500 (View on PubMed)

Other Identifiers

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22051012

Identifier Type: -

Identifier Source: org_study_id

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