Endotracheal Tube Shapes for Intubation With Videolaryngoscope

Sponsor

Eunah Cho, MD (Other)

Overall Status

Completed

CT.gov ID

NCT03524547

Collaborator

(none)

222

Enrollment

Location

Arms

1.2

Actual Duration (Months)

182.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Device: J shaped stylet used for endotracheal intubation Device: 60-degrees stylet used for endotracheal intubation	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

222 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Comparison of Endotracheal Tube Shapes for Intubation With Videolaryngoscope in Normal Airways

Actual Study Start Date :

May 28, 2018

Actual Primary Completion Date :

Jul 4, 2018

Actual Study Completion Date :

Jul 4, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: J shaped stylet used for endotracheal intubation After inserting a stylet into the endotracheal tube, the tube will be molded into a J-shape.
Active Comparator: 60-degrees Endotracheal tube will be bent 60 degrees.	Device: 60-degrees stylet used for endotracheal intubation After inserting a stylet into the endotracheal tube, the tube will be bent 60-degrees.

Arm

Intervention/Treatment

Experimental: 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.

Device: J shaped stylet used for endotracheal intubation

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

Active Comparator: 60-degrees

Endotracheal tube will be bent 60 degrees.

Device: 60-degrees stylet used for endotracheal intubation

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

Outcome Measures

Primary Outcome Measures

Time to intubate [20 minutes after induction started.]
the time took from the blade passing through the incisor teeth of the patient to the first end tidal CO2 appears on the anesthesia monitor screen.

Secondary Outcome Measures

Numbers of intubation attempts [20 minutes after induction started.]
numbers of attempts for the successful endotracheal intubation
Level of difficulty in intubation [20 minutes after induction started.]
easy, moderate, difficult

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kangbuk Samsung Hospital	Seoul		Korea, Republic of	03181

Sponsors and Collaborators

Eunah Cho, MD

Investigators

Principal Investigator: Eunah Cho, M.D., Kangbuk Samsung Hospital
Principal Investigator: Hyunyoung Lim, M.D., Hanyang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eunah Cho, MD, Clinical Assistant Professor, Kangbuk Samsung Hospital

ClinicalTrials.gov Identifier:

NCT03524547

Other Study ID Numbers:

2018-01-033-001
2018-01-016-003

First Posted:

May 15, 2018

Last Update Posted:

Jul 9, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 9, 2018