Effect of Cricoid Pressure on Macintosh, McGrath X-Blade and Glidescope Videolaryngoscopes in Rapid Sequence Induction Intubation

July 19, 2016 updated by: Zehra Ipek ARSLAN, Kocaeli University

Videolaryngoscopes for Rapid Sequence Intubation

Non- Fasted patients need rapid sequence intubation. The investigators aimed to compare the intubation times of Macintosh , and McGrath X-Blade or Glidescope in these Ascenario.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators fecidedir to enroll the ASA I-II 120 patients and divided them into three groups ( Macintosh / McGarth X-Blade / Glidescope). The investigators recorded the patients' airway data and demographic variables. All patients were premeditated with midazolam. Standard monitoring including electrocardiogram, non invasive blood pressure, pulse oximetry, heart rate were recorded before induction , after induction, after the device insertion and every 1 minutes after intubation. Cormac-Lehan grades with these video laryngoscope were recorded also. We recorded the optimization maneuvers ( like handling force, reinserting, cricoid pressure). Bloodstaining on the devices after removal were recorded as mucosal damage. Teeth, tongue, lip damage were also recorded. Sore throat, bronchospasm, wheezing were recored at recovery unit.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kocaeli, Turkey, 41900
        • Kocaeli University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I-II
  • BMI< 30
  • 18-65 years of age

Exclusion Criteria:

  • known difficult airway
  • BMI > 30
  • < 18 years of age
  • > 65 years of age
  • known respiratory tract infection in 10 days
  • pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: İnsertion time
handling the device till the glottic visualisation of Macintosh, McGrath MAC X-Blade and Glidescope
Device: Macintosh
Direct laryngoscopy
Other Names:
  • direct laryngoscopy
Device: Glidescope
Glidescope videolaryngoscope
Other Names:
  • videolaryngoscope
Device: McGrath MAC X-Blade
McGrath MAC X-Blade videolaryngoscope
Other Names:
  • videolaryngoscope
Active Comparator: intubation time
handling the device till seeing the endotracheal tube entering from the vocal cords Macintosh, McGrath MAC X-Blade and Glidescope
Device: Macintosh
Direct laryngoscopy
Other Names:
  • direct laryngoscopy
Device: Glidescope
Glidescope videolaryngoscope
Other Names:
  • videolaryngoscope
Device: McGrath MAC X-Blade
McGrath MAC X-Blade videolaryngoscope
Other Names:
  • videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cormack lehane grade with cricoid pressure
Time Frame: 1 minutes
1 minutes
intubation time
Time Frame: 2 minutes
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KOÜ KAEK 2015/267

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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