Tracheal Intubation With Collar Immobilisation : a Comparison of Glidescope and Fastrach

March 31, 2015 updated by: Zehra Ipek ARSLAN, Kocaeli University

A Comparison of Glidescope and ILMA in Simulated Sercial Spine Injury

Intubation must be done with utmost care in cervical trauma patients. cervical spine motion must be minimized and intubation must be fast. The aim of this study was to compare the effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients undergoing elective surgery were enrolled in this trial. After standard monitorisation including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were divided into two groups glidescope and fastrach. Rigid collar was placed then patients were intubated with one of these devices. Mask ventilations with or without collar were recorded. insertion times, intubation times of the devices were recorded. Peroperative hemodynamic parameters and postoperative minor complications were also recoded.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

inclusion criteria: ASA I-II , 18-60 years of age undergoing elective surgery requiring intubation exclusion criteria:

- pregnancy reflux nonfasted head and neck tumors recent flue in 2 weeks

Study Type

Interventional

Enrollment (Actual)

94

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 School of Medicine

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:

  • 18-65 years of age
  • ASA I-II
  • requiring intubation
  • BMI<35

Exclusion Criteria:

  • less than 18 or higher than 65
  • ASA III-IV
  • BMI> 35
  • PREGNANT
  • head and neck tumors

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glidescope videolaryngoscope
cervical collar was applied to 47 patients then facemask ventilations were recoded intubated with Glidescope and insertion time: handling of the device till the good glottic visualisation intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device after removal heart rate preinduction heart rate postinduction heart rate postinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation wrere recorded. postoperative minor complications were recorded.
Device: Glidescope
videolaryngoscope
Active Comparator: Intubating laryngeal mask airway
cervical collar was applied to 47 patients then facemask ventilations through the collar were recorded and intubated with ILMA insertion time: handling of the device till the good glottic visualisation appears intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device heart rate preinduction heart rate postinduction heart rate posinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation
Device: ILMA
handling of the device till the optimal ventilation achieved
Other Names:
  • FASTRACH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
intubation times
Time Frame: From handling of the device till intıbation
From handling of the device till intıbation

Secondary Outcome Measures

Outcome Measure
Time Frame
Heart rate
Time Frame: From Preoperative heart rate till 15 minutes After intubation
From Preoperative heart rate till 15 minutes After intubation
Mean arterial pressure
Time Frame: From preinduction till 15 minutes after intubation
From preinduction till 15 minutes after intubation

Other Outcome Measures

Outcome Measure
Time Frame
minor complications
Time Frame: From the end of surgery till 2 hours postoperatively
From the end of surgery till 2 hours postoperatively
Mucosal damage
Time Frame: Bloodstain on the device after removal
Bloodstain on the device after removal

Collaborators and Investigators

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

Sponsor

Kocaeli University

Investigators

  • Principal Investigator: Zehra I ARSLAN, Specialist, Anesthesiology and Reanimation

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

April 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

September 18, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Estimate)

April 1, 2015

Last Update Submitted That Met QC Criteria

March 31, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KOÜ KAEK 2013/33

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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