Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy

April 1, 2018 updated by: derya özkan, Diskapi Teaching and Research Hospital

Comparison of Intubation Conditions of the Articulating Stylet and Intubating Stylet Guided Videolaryngoscopy in Patients With Difficult Airway

Indirect videolaryngoscopes provide an improved view of the glottis. Unfortunately enhanced video blade angulation leads to difficulty in passage of the endotracheal tube (ETT) towards the larynx around the steep blade angulation despite adequate visualization of the glottis. Pre-shaping the ETT with the rigit malleable stylet is recommended. The investigators hypothesized that using articulating stylet (AS) would enhance first attempt intubation, shorten the intubation time, reduce the possibility of the soft tissue trauma compared to conventional intubation stylet (IS) in patients with difficult airway .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with known airway difficulty (anticipated difficult airway (ADA) score >6) will be included to the study.

All patients will receive general anesthesia for a variety of elective surgical procedure. Tracheal intubation will be performed by senior anesthesiologist. Patients will be intubated using AS-videolaryngoscope (n= 24) or IS-videolaryngoscope (n=24) randomly. Patients demographic details (age 18-65 yr, body mass index, ASA phisical status), ADA scores, Cormack-Lehane scores, intubation difficulty scores, intubation attempts, intubation time, hemodynamic variables, sore throat, anesthesiologists satisfaction will be recorded.

Study Type

Interventional

Enrollment (Actual)

49

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
      • Ankara, Turkey, 06110
        • Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey

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 1-2 physical status (Anticipated difficult airway) ADA scores >6 Elective surgery

Exclusion Criteria:

  • ASA 3-4 physical status Immobilizedcervical spine

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: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group A
articulating stylet
Device: articulating stylet
patient who intubated with articulating stylet
ACTIVE_COMPARATOR: group C
conventional stylet
Device: conventional stylet
patient who intubated with conventional stylet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intibation time
Time Frame: Through intubation completion, an avarage of 5 minutes
Total intubation time (second)
Through intubation completion, an avarage of 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tracheal intubation attempts
Time Frame: Through intubation completion, an avarage of 5 minutes
number of intubation attempts
Through intubation completion, an avarage of 5 minutes

Collaborators and Investigators

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

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Principal Investigator: Derya Özkan, MD, Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2016

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

June 13, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (ESTIMATE)

June 20, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 3, 2018

Last Update Submitted That Met QC Criteria

April 1, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 27/28

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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