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

NCT04457453 | Completed

• 1 other identifier: AJIRB-MED-OBS-19-507
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation;Difficult

Keywords

Trendelenburg position; Sellick position; pulmonary aspiration; video laryngoscope

Outcome Measures

Primary Outcomes (1)

• Intubation time

  from endotracheal tube pass the teeth to end-tidal CO2 appear

  within 5 minutes

Secondary Outcomes (1)

• Intubation difficulty score

  within 5 minutes

Study Arms (3)

control group

ACTIVE COMPARATOR

intubation with direct laryngoscope in sniffing position

Other: Macintosh in sniffing position

direct laryngoscope in Trendelenburg and Sellick position

EXPERIMENTAL

intubation with direct laryngoscope in Trendelenburg and Sellick position

Other: Macintosh in Trendelenburg position and Sellick position

video laryngoscope in Trendelenburg and Sellick position

EXPERIMENTAL

intubation with video laryngoscope in Trendelenburg and Sellick position

Other: AceScope in Trendelenburg position and Sellick position

Interventions

Macintosh in sniffing position OTHER

Macintosh direct intubation in sniffing position

control group

Macintosh in Trendelenburg position and Sellick position OTHER

Macintosh direct laryngoscopic intubation in Trendelenburg position and Sellick position

direct laryngoscope in Trendelenburg and Sellick position

AceScope in Trendelenburg position and Sellick position OTHER

AceScope videolaryngoscopic intubation in Trendelenburg position and Sellick position

video laryngoscope in Trendelenburg and Sellick position

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou universitiy school of medicine

Suwon, Gyeong-gi Do, 16499, South Korea

Location

MeSH Terms

Interventions

Head-Down Tilt

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• yun jeong chae, Ph.D

  Ajou University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: March 9, 2021
• Primary Completion: April 7, 2022
• Study Completion: April 7, 2022
• Last Updated: August 25, 2023

Record last verified: 2023-08

Locations

KR (1)