The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope

NCT ID: NCT03962374

Last Updated: 2022-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-21

Study Completion Date

2023-06-30

Brief Summary

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The purpose of this study is to compare the effect of frova and stylet on the success rate of tracheal intubation when using a video laryngoscope.

Detailed Description

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Conditions

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Anesthesia, General

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Frova

Frova will be used to facilitate the endotracheal intubation.

Group Type EXPERIMENTAL

Frova

Intervention Type DEVICE

Frova will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.

Stylet

Stylet will be used to facilitate the endotracheal intubation.

Group Type ACTIVE_COMPARATOR

Stylet

Intervention Type DEVICE

Stylet will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.

Interventions

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Frova

Frova will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.

Intervention Type DEVICE

Stylet

Stylet will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 1\. adult patients aged over 19 years who are undergoing endotracheal intubation for elective surgery.
* 2\. Patients who have one of the predictors of difficult intubation such as Mallampati classification 3 or 4, limited the movement of the neck, body mass index less than 35 kg/m2, a distance from the tip of the chin to the thyroid cartilage of less than 6.5 cm, a interincisor distance less than 3.5 cm, inability to protrude of lower incisors over the upper incisors, or a diagnosis of obstructive sleep apnea.

Exclusion Criteria

* 1\. Patients receiving emergency surgery
* 2\. Pregnant women
* 3\. Patients scheduled for oral surgery such as tonsillectomy, vocal cord surgery
* 4\. Patients who have a history of ankylosing spondylitis or have a large tumor of 4 cm or more on the tongue and need an awake intubation
* 5\. Patients who are at risk of vomiting due to not fasting time
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyun Joo Kim, MD, Ph.D

Role: CONTACT

02-2224-1389

Facility Contacts

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Hyun Joo Kim, M.D., Ph.D.

Role: primary

82-2-2224-1389

Other Identifiers

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4-2019-0289

Identifier Type: -

Identifier Source: org_study_id

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