The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure

February 13, 2019 updated by: Chang Gung Memorial Hospital

The Clarus Video System (Trachway) and Direct Laryngoscope for Endotracheal Intubation With Cricoid Pressure in Simulated Rapid Sequence Induction Intubation: A Prospective Randomized Controlled Trial

During an emergency endotracheal intubation, rapid sequence induction intubation with cricoid pressure is frequently implemented to prevent aspiration pneumonia. When properly applied, cricoid pressure may not affect glottic view during endotracheal intubation with either a direct laryngoscope or a video laryngoscope. However, the application of cricoid pressure is likely to prolong the intubation time. Limited mouth opening or vulnerable teeth, which often accompany the patients requiring emergency intubation, are the two common factors to deter the intubators from using a laryngoscopic device. Besides, the blade of a laryngoscopic device is often too bulky for a narrow mouth opening, and the blade always bears a level force on upper incisors while the intubator is lifting epiglottis during intubation, which is liable to tooth fracture. In this prospective randomized study, the investigators compare the use of the Clarus Video System and that of direct laryngoscope (Macintosh Laryngoscope) in patients undergoing endotracheal intubation in simulated rapid sequence induction intubation for the primary goals of the first attempt success rate and intubation time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

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

  • Taiwan
      • Taoyuan, Taiwan
        • Chang Gung Memorial Hospital

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Older than 20 years of age
  • Scheduled for elective surgery under general anesthesia

Exclusion Criteria:

  • BMI (Body Mass Index) > 35 kg/m2
  • Interincisor distance < 3 cm
  • Poor dentition
  • Upper airway tumor
  • Limited neck mobility
  • Pregnancy
  • History of difficult tracheal intubation

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intubation with the Clarus Video System as a video stylet
Device: the Clarus Video System as a video stylet
video-guided intubation
Other Names:
  • Trachway as a video stylet
Experimental: Intubation with the Clarus Video System as a lightwand
Device: the Clarus Video System as a lightwand
The endotracheal tube will be initially guided into larynx in the dimly lit operating room by a bright glow moving in the anterior soft tissue of the neck and finally by the image of the trachea rings on the video screen.
Other Names:
  • Trachway as a lightwand
Active Comparator: Intubation with direct laryngoscope
Device: direct laryngoscope
Macintosh laryngoscope size 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The first attempt success rate
Time Frame: After intubation immediately
After intubation immediately
Intubation time
Time Frame: After intubation immediately
Intubation time was counted from the inserting the device into the patient's mouth to viewing the endotracheal tube into the trachea.
After intubation immediately

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 1 minute and 5 minutes after intubation
Measure blood pressure in millimeter of mercury by non-invasive blood pressure before induction, 1 minute after intubation, and 5 minutes after intubation
1 minute and 5 minutes after intubation
Heart rate
Time Frame: 1 minute and 5 minutes after intubation
Measure heart rate in beats per minute by electrocardiography monitor before induction, 1 minute after intubation, and 5 minutes after intubation
1 minute and 5 minutes after intubation
Sore throat
Time Frame: On postoperative day 1
Documented by a blinded observer on the next day. Sore throat was graded according to numerical rating scale (NRS): none, NRS = 0; mild, NRS = 1-3; moderate, NRS = 4-6; severe, NRS = 7-10.
On postoperative day 1
Mucosal injury
Time Frame: On postoperative day 1
Documented by a blinded observer on the next day. "Yes" is defined as any oral mucosal lesion reported by participants.
On postoperative day 1

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: An-Hsun Cho, PhD, Chang Gung Memorial Hospital

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 (Actual)

November 4, 2016

Primary Completion (Actual)

April 13, 2018

Study Completion (Actual)

April 14, 2018

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (Actual)

February 15, 2019

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201601025A3C502

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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