NCT03279172

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2017

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

August 7, 2017

Last Update Submit

September 11, 2017

Conditions

Intraocular PressureIntubation;Difficult

Keywords

videolaryngoscopeintraocular pressureDirect laryngoscope

Outcome Measures

Primary Outcomes (1)

  • High intraorbital pressure

    IOP 18-22 mmHg

    1 minute

Study Arms (2)

Group Direct Laryngoscope

EXPERIMENTAL

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 laryngoscopeProcedure: videolaryngoscope

Group videolaryngoscope

EXPERIMENTAL

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 laryngoscopeProcedure: videolaryngoscope

Interventions

direct laryngoscopePROCEDURE

procedure entubatıon

Group Direct LaryngoscopeGroup videolaryngoscope
videolaryngoscopePROCEDURE
Group Direct LaryngoscopeGroup videolaryngoscope

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective Surgery under general anaesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

Ankara, Altındag, 06100, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 22042705BACKGROUND

  • 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.

    PMID: 27833500RESULT

Study Officials

  • Ceyda Ozhan Caparlar

    University of Health Dıskapı Yıldırım Beyazıt Training and Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator, Clinical Specialist of anesthesiology

Study Record Dates

First Submitted

August 7, 2017

First Posted

September 12, 2017

Study Start

January 1, 2017

Primary Completion

August 3, 2017

Study Completion

August 4, 2017

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

TU(1)