Comparison of Direct and Video Laryngoscope During Endotracheal Intubation in Sellick and Trendelenburg Position

August 24, 2023 updated by: yun jeong chae, Ajou University School of Medicine

Comparison of Direct Laryngoscope and Video Laryngoscope During Endotracheal Intubation in Sellick and Trendelenburg Position to Prevent Pulmonary Aspiration

Pulmonary aspiration during tracheal intubation for anesthesia can cause fatal respiratory complications. Takenaka's study of mannequins reported that the risk of airway contamination by reflux gastric contents could be minimized by applying a 15-degree Trendelenburg position and a Sellick position with neck extention. However, the clinical performance of tracheal intubation in this position has not been studied. Also, the difference between the effects of direct laryngoscope and video laryngoscope on tracheal intubation is not known yet.

Therefore, this study aims to compare the intubation time among intubation through direct laryngoscope and video laryngoscope in the Sellick and Trendelenburg position, and intubation in the conventional sniffing position.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

  • Korea, Republic of
    • Gyeong-gi Do
      • Suwon-si, Gyeong-gi Do, Korea, Republic of, 16499
        • Ajou universitiy 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

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >= 19 years old
  • ASA I or II
  • Patients who need nasotracheal intubation for surgery

Exclusion Criteria:

  • Anatomical deformity in head and neck
  • Patients who have risk of pulmonary aspiration
  • Patients with cervical deformities or pain
  • BMI >35

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
intubation with direct laryngoscope in sniffing position
Other: Macintosh in sniffing position
Macintosh direct intubation in sniffing position
Experimental: direct laryngoscope in Trendelenburg and Sellick position
intubation with direct laryngoscope in Trendelenburg and Sellick position
Other: Macintosh in Trendelenburg position and Sellick position
Macintosh direct laryngoscopic intubation in Trendelenburg position and Sellick position
Experimental: video laryngoscope in Trendelenburg and Sellick position
intubation with video laryngoscope in Trendelenburg and Sellick position
Other: AceScope in Trendelenburg position and Sellick position
AceScope videolaryngoscopic intubation in Trendelenburg position and Sellick position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation time
Time Frame: within 5 minutes
from endotracheal tube pass the teeth to end-tidal CO2 appear
within 5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation difficulty score
Time Frame: within 5 minutes
Intubation difficulty scale (IDS) score
within 5 minutes

Collaborators and Investigators

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

Sponsor

Ajou University School of Medicine

Investigators

  • Principal Investigator: yun jeong chae, Ph.D, Ajou University School of Medicine

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)

March 9, 2021

Primary Completion (Actual)

April 7, 2022

Study Completion (Actual)

April 7, 2022

Study Registration Dates

First Submitted

June 30, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 24, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AJIRB-MED-OBS-19-507

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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