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Clinical Trials/NCT04520581
NCT04520581UnknownNot Applicable

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

Seoul National University Hospital2 sites in 1 country238 target enrollmentStarted: March 24, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
238
Locations
2
Primary Endpoint
First intubation success rate for each between two group

Study Overview

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

First intubation success rate for each between two group

Time Frame: Immediately after intubation

First laryngoscope tries was success using detection of end tidal CO2

Secondary Outcomes

  • 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)
  • First intubation time(within 60 seconds)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yu-Kyung Bae

clinical professor

Seoul National University Hospital

Study Sites (2)

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