Laryngoscope-assisted Lightwand Intubation and Cervical Spine Motion

April 26, 2015 updated by: Seoul National University Hospital

A Randomized Trial on Comparison of Effects of Two Lightwand Intubation Techniques on Cervical Spine Motion: Laryngoscope-assisted vs. Conventional Lightwand Intubation

The aim of the study is to compare the effect of the laryngoscope-assisted lightwand intubation technique vs. the conventional lightwand intubation technique on the cervical spine motion during intubation in patients with the simulated cervical immobilization.

Study Overview

Detailed Description

In clinical practice, the investigators have occasionally experienced some difficulties in the lightwand intubation in patients with cervical spine instability because manual in-line stabilization during intubation hinders free movements of the lightwand such as advancement, withdrawal, and scooping in the oral cavity. For this reason, jaw thrust is often used to secure enough space for free movements of the lightwand in the oral cavity in the traditional lightwand intubation technique. A recent study showed that laryngoscope-assisted lightwand intubation provided more successful intubation on the first attempt and less scooping movement than the traditional lightwand intubation by facilitating free movements of the lightwand in the oral cavity in patients with cervical immobilization during intubation for cervical spine surgery. In the laryngoscope-assisted lightwand intubation technique, the direct laryngoscope may provide sufficient space for free movements of the lightwand in the oral cavity without jaw thrust, which can result in cervical spine movement. However, the effect of the laryngoscope-assisted lightwand intubation technique on cervical spine motion is not investigated yet.

Study Type

Interventional

Enrollment (Anticipated)

22

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.

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with American Society of Anesthesiologists physical status of 1-2 and age of 18-80 years undergoing elective endovascular coiling to secure cerebral aneurysm under general anesthesia in neuroangiographic rooms.

Exclusion Criteria:

  • Patients with the upper airway abnormalities, such as inflammation, abscesses, tumours, polyps, or trauma.
  • Patients with past medical history of gastro-oesophageal reflux disease and previous airway surgery, a high risk of aspiration, coagulation disorders, or Hunt Hess grade of 3-5.
  • Body mass index > 30

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
laryngoscope-assisted lightwand intubation - traditional lightwand intubation
laryngoscope-assisted lightwand intubation
traditional lightwand intubation
Experimental: Group B
traditional lightwand intubation - laryngoscope-assisted lightwand intubation
laryngoscope-assisted lightwand intubation
traditional lightwand intubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum cervical spine motion
Time Frame: during tracheal intubation
maximum angles measured at the occiput-C1, C1-C2, C2-C5 segments.
during tracheal intubation

Secondary Outcome Measures

Outcome Measure
Time Frame
intubation time
Time Frame: during tracheal intubation
during tracheal intubation
number of intubation trial
Time Frame: during tracheal intubation
during tracheal intubation
sore throat, pain score
Time Frame: after extubation ~ postoperative day 1
after extubation ~ postoperative day 1

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Hee Pyung Park, MD PhD, Seoul National University of 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.

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

May 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 26, 2015

First Posted (Estimate)

April 30, 2015

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 26, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • LALI

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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