Endotracheal Tube Shapes for Intubation With Videolaryngoscope

NCT ID: NCT03524547

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-28
• Study Completion Date: 2018-07-04

Brief Summary

In this study, investigators will compare the efficacy of two shapes of endotracheal tube molded by stylet in endotracheal intubation using videolaryngoscope (McGrath MAC®). The participants will randomly be divided into two groups; J-shaped tube and 60-degrees-curved tube.

Detailed Description

Since the intubation using videolaryngoscope does not need straightened oral-pharyngeal-laryngeal axis, certain curvature of endotracheal tube is needed for the successful intubation using the videolaryngoscope.

Participants in both groups will be intubated with videolaryngoscope (McGrath MAC®). Stylet will be inserted in the endotracheal tubes and will be bent to a specific shape by the assigned group. In the J-shaped tube group, endotracheal tube will be molded to a shape similar to the blade of the videolaryngoscope (McGrath MAC®). In the 60-degrees-curved tube group, endotracheal tube will be bent 60 degrees. Time to intubation, intubation attempts and ease of intubation wil be assessed.

Conditions

Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

J-shaped

Endotracheal tube will be molded into a J-shape that is similar to that of Macintosh type blade of a McGrath MAC® videolaryngoscope.

Group Type: EXPERIMENTAL

J shaped stylet used for endotracheal intubation

Intervention Type: DEVICE

After inserting a stylet into the endotracheal tube, the tube will be molded into a J-shape.

60-degrees

Endotracheal tube will be bent 60 degrees.

Group Type: ACTIVE_COMPARATOR

60-degrees stylet used for endotracheal intubation

Intervention Type: DEVICE

After inserting a stylet into the endotracheal tube, the tube will be bent 60-degrees.

Interventions

J shaped stylet used for endotracheal intubation

After inserting a stylet into the endotracheal tube, the tube will be molded into a J-shape.

Intervention Type: DEVICE

60-degrees stylet used for endotracheal intubation

After inserting a stylet into the endotracheal tube, the tube will be bent 60-degrees.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients scheduled for the surgery under general anesthesia
• Adult patients from 18 years to 65 years
• American society of Anesthesiologist physical status 1,2,3

Exclusion Criteria

• Previously diagnosed for the difficult intubation
• Pregnancy
• Obesity (Body mass index over 40 g/m^2)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunah Cho, MD

OTHER

Sponsor Role: lead

Responsible Party

Eunah Cho, MD

Clinical Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eunah Cho, M.D.

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Hyunyoung Lim, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hanyang University

Locations

Kangbuk Samsung Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2018-01-016-003

Identifier Type: OTHER

Identifier Source: secondary_id

2018-01-033-001

Identifier Type: -

Identifier Source: org_study_id