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Clinical Trials/NCT04520581
NCT04520581
Unknown
Not Applicable

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

Seoul National University Hospital1 site in 1 country238 target enrollmentMarch 24, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endotracheal Intubation
Sponsor
Seoul National University Hospital
Enrollment
238
Locations
1
Primary Endpoint
First intubation success rate for each between two group
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 24, 2020
End Date
March 31, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yu-Kyung Bae

clinical professor

Seoul National University Hospital

Eligibility Criteria

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)

Study Sites (1)

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