Orotracheal Intubation in Adult Patients: A Comparison of Standard Airtraq , Nasotracheal Airtraq Combined With a Stylet Inserted Endotracheal Tube and Standard Airtraq Combined Fiberoptic Intubation

June 26, 2019 updated by: Zehra Ipek ARSLAN, Kocaeli University

A Comparison of Airtraq and Nasotracheal Airtraq for Orotracheal Intubation

Adult patients requiring endotracheal intubation divided into three groups; standard Airtraq, Nasotracheal Airtraq + styletted endotracheal tube and Airtraq + fiberoptic combination groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We enroll lean adult patients requiring endotracheal intubation. Using a sealed envelope technique they divided into three groups; Standard Airtraq and Nasotracheal Airtraq + styletted endotracheal tube and Standard Airtraq + fiberoptic combination. Demographic characteristics and airway management variables such; age, gender, height, weight, ASA status, tooth morphology, tiro mental and sternomental distance were recorded. Insertion times, intubation times and total intubation times with these devices will be recorded. Hemodynamic parameters recorded such as; heart rate will be recorded baseline , after anesthesia, after insertion, just after and then every 2 minutes intervals after intubation. sore throat, hoarseness, dysphasia, bronchospasm were also recorded postoperatively.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

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
        • Kocaeli University Medical Faculty

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:

  • BMI<30
  • > 18 AGE
  • requiring endotracheal intubation
  • ASA 1-2

Exclusion Criteria:

  • BMI> 30
  • < 18 AGE
  • ASA III-IV
  • upper respiratory infection past ten 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: insertion time
1 minute Airtraq, nasotracheal Airtraq + styletted tube and airtraq + fiberoptic
Device: Airtraq + fiberoptic
video laryngoscope with a monitor
Other Names:
  • videolaryngoscope
Device: Airtraq
video laryngoscope with a monitor
Other Names:
  • videolaryngoscope
Device: Nasotracheal Airtraq + styletted tube
video laryngoscope with a monitor
Other Names:
  • videolaryngoscope
Active Comparator: intubation time
2 minutesAirtraq, nasotracheal Airtraq + styletted tube and airtraq + fiberoptic
Device: Airtraq + fiberoptic
video laryngoscope with a monitor
Other Names:
  • videolaryngoscope
Device: Airtraq
video laryngoscope with a monitor
Other Names:
  • videolaryngoscope
Device: Nasotracheal Airtraq + styletted tube
video laryngoscope with a monitor
Other Names:
  • videolaryngoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: 6 months
entering the oral cavity till intubation
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insertion time
Time Frame: 6 months
entering the oral cavity till the optimal visualization
6 months

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 (Actual)

October 15, 2018

Primary Completion (Actual)

February 20, 2019

Study Completion (Actual)

February 20, 2019

Study Registration Dates

First Submitted

October 12, 2018

First Submitted That Met QC Criteria

October 15, 2018

First Posted (Actual)

October 17, 2018

Study Record Updates

Last Update Posted (Actual)

June 28, 2019

Last Update Submitted That Met QC Criteria

June 26, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • KIA 2018/446

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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