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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03524547
Other study ID # 2018-01-033-001
Secondary ID 2018-01-016-003
Status Completed
Phase N/A
First received
Last updated
Start date May 28, 2018
Est. completion date July 4, 2018

Study information

Verified date July 2018
Source Kangbuk Samsung Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 MACĀ®). 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 MACĀ®). 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.


Recruitment information / eligibility

Status Completed
Enrollment 222
Est. completion date July 4, 2018
Est. primary completion date July 4, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Kangbuk Samsung Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Eunah Cho, MD

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to intubate 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. 20 minutes after induction started.
Secondary Numbers of intubation attempts numbers of attempts for the successful endotracheal intubation 20 minutes after induction started.
Secondary Level of difficulty in intubation easy, moderate, difficult 20 minutes after induction started.
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