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NCT04457453 Clinical Trial

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

Intubation;Difficult Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04457453
Other study ID # AJIRB-MED-OBS-19-507
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 9, 2021
Est. completion date April 7, 2022

Study information
Verified date August 2023
Source Ajou University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date April 7, 2022
Est. primary completion date April 7, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Macintosh in sniffing position
Macintosh direct intubation in sniffing position
• Macintosh in Trendelenburg position and Sellick position
Macintosh direct laryngoscopic intubation in Trendelenburg position and Sellick position
• AceScope in Trendelenburg position and Sellick position
AceScope videolaryngoscopic intubation in Trendelenburg position and Sellick position

Locations
Country Name City State
Korea, Republic of Ajou universitiy school of medicine Suwon-si Gyeong-gi Do

Sponsors (1)
Lead Sponsor Collaborator
Ajou University School of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intubation time from endotracheal tube pass the teeth to end-tidal CO2 appear within 5 minutes
Secondary Intubation difficulty score Intubation difficulty scale (IDS) score within 5 minutes
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