The Use of "O" Shaped- Endotracheal Tube During Intubation for General Anesthesia: Prospective Randomized Trial

NCT ID: NCT04520581

Last Updated: 2020-08-20

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

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-24

Study Completion Date

2022-03-31

Brief Summary

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This study is prospective randomized trial study. "O" type tracheal intubation tube is anatomically consistent and will able to increase the success rate of first intubation without any other external help.

Detailed Description

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This study is divided into two groups. : control vs. "O" shape endotracheal tube.

The investigator was studied 238 consecutive the American Society of Anesthesiologists' physical grades I and II adult patients scheduled to undergo general anesthesia requiring tracheal intubation for elective surgery. Exclusion criteria included a gross anatomical abnormality, before surgery of the head, neck and cervical spine, previously difficult tracheal intubation, loose teeth, or those requiring a rapid sequence or awake intubation, moderate or severe obstructive/restrictive pulmonary disease accompanied by pulmonary function tests. Anesthesia was induced with remifentanyl 3ng/kg, propopol 1-2 mg/kg or TIVA 2% fresopol 4ug/dL, remifentanyl 3ng/dL and rocuronium 0.8 mg/kg to facilitate tracheal intubation. Laryngoscopy was performed after the loss of the fourth twitch in the train-of-four in response to ulnar nerve stimulation. All laryngoscopies using a #4 Macintosh blade were performed with the patient placed in the sniffing position. Tracheal intubation was performed without assistance (ex. External laryngeal manipulation, Used stylet). A single experienced anesthesiologist, blinded to each group, performed all of the direct laryngoscopies and classified the laryngoscopic view according to the modified Cormack and Lehane grade, measured number of attempts, intubation time and blood pressure and heart rate before/ after intubation.

Conditions

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Endotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Use in the shape of an endotracheal tube.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group "O"

Just before the induction of medicine is injected, the assistant makes endotracheal tube into "O" shape.

Group Type EXPERIMENTAL

group "O"

Intervention Type OTHER

Endotracheal tube was made "O" shape by assistants.

Interventions

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group "O"

Endotracheal tube was made "O" shape by assistants.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Consented to participate in the study
* Aged 19 years or older
* The American Society of Anesthesiologists' physical grades I and II
* Undergo elective surgery under general anesthesia

Exclusion Criteria

* Do not agree to participate in research
* Previously difficult tracheal intubation
* Rapid induction of anesthesia
* Previous c-spine disc or had surgery
* Teeth are severely shaken or poor
* Moderate or severe obstructive/restrictive pulmonary disease accompanied by pulmonary function tests
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yu-Kyung Bae

clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu-Kyung Bae

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeongggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yu-Kyung Bae

Role: CONTACT

+821057054801

Facility Contacts

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Yu-kyung Bae

Role: primary

+821057054801

Other Identifiers

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B-2003-603-304

Identifier Type: -

Identifier Source: org_study_id

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