NCT04520581

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 24, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 13, 2020

Last Update Submit

August 18, 2020

Conditions

Endotracheal Intubation

Outcome Measures

Primary Outcomes (1)

  • First intubation success rate for each between two group

    First laryngoscope tries was success using detection of end tidal CO2

    Immediately after intubation

Secondary Outcomes (3)

  • First intubation time

    within 60 seconds

  • Number of attempts

    From the first tracheal intubation failure to the next successful tracheal intubation

  • Measured vital sign

    immediately before intubation and within 5 minites after intubation

Study Arms (2)

Control

NO INTERVENTION

Use in the shape of an endotracheal tube.

Group "O"

EXPERIMENTAL

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

Other: group "O"

Interventions

group "O"OTHER

Endotracheal tube was made "O" shape by assistants.

Group "O"

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeongggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Interventions

O-antigen, Acinetobacter strain 90

Study Officials

  • Yu-Kyung Bae

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Kyung Bae

CONTACT

+821057054801vansuri27@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

August 13, 2020

First Posted

August 20, 2020

Study Start

March 24, 2020

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

August 20, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)