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CompletedNCT03289767Updated Nov 12, 2020

Simple Preparation of Endotracheal Tube

An interventional study of Curved-tube in Endotracheal Tube, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-11-12.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
139
Allocation
Randomized
Ages
20 Years to 80 Years
Sex
All
01

Study summary

To observe the effect of additional E-tube angulation on intubation time and success rate.

Read the detailed description

The hypothesis of this study is that shaping endotracheal tube by end-to-end connection before induction will provide more optimal angulation for endotracheal intubation.

02

Conditions studied

  • Endotracheal Tube
03

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients scheduled for elective surgery requiring general anesthesia and tracheal intubation

Exclusion criteria

Exclusion Criteria:

  • Patients with congenital or acquired upper airway lesions
  • Patients with high risk of aspiration
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
139 participants (actual)

Study arms

  • Experimental
    Curved-tube

    Giving additional curve to the endotracheal tube by simple preparation.

    Other: Curved-tube

  • No intervention
    Control

    No other manipulation of the endotracheal tube is done.

Interventions

  • OtherCurved-tube

    Connecting both ends of the endotracheal tube ("O" shape) for 5-min and releasing it provides additional anterior angle temporarily.

05

What researchers measure

Primary outcomes

  1. Successful intubation on first attempt

    Whether successful intubation is done on first attempt or on additional attempt

    Time frame: On endotracheal intubation up to 1 min

Secondary outcomes

  1. Time to intubate (TIT)

    The TIT started when the blade first passed the lips, and ended when the the detection of end-tidal CO2 trace

    Time frame: On endotracheal intubation up to 1 min

06

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
07

Registry details

Key details

Study ID
NCT03289767
Lead sponsor
Seoul National University Hospital
Responsible party
Jeong-Hwa Seo (Professor, Seoul National University Hospital) — Principal investigator
First posted
Sep 21, 2017
Start date
Dec 5, 2017
Primary completion
May 10, 2018
Completion
May 10, 2018
Last update
Nov 12, 2020

Study contacts

Jeong-Hwa Seo, PhD
study chair · Seoul National University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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