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

Last updated: August 18, 2020
Sponsor: Seoul National University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endotracheal Intubation

Treatment

N/A

Clinical Study ID

NCT04520581
B-2003-603-304
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 pulmonaryfunction tests

Study Design

Total Participants: 238
Study Start date:
March 24, 2020
Estimated Completion Date:
March 31, 2022

Study 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.

Connect with a study center

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeongggi-do 13620
    Korea, Republic of

    Active - Recruiting

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