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

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.

Study Overview

• Status: Unknown
• Conditions: Endotracheal Intubation
• Intervention / Treatment: Other: group "O"

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 Type: Interventional
• Enrollment (Anticipated): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu-kyung Bae; Phone Number: +821057054801; Email: vansuri27@gmail.com

Study Locations

• Korea, Republic of
  • Gyeongggi-do
    • Seongnam-si, Gyeongggi-do, Korea, Republic of, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Yu-kyung Bae; Phone Number: +821057054801; Email: vansuri27@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Use in the shape of an endotracheal tube.
EXPERIMENTAL: Group "O"; Just before the induction of medicine is injected, the assistant makes endotracheal tube into "O" shape.	Other: group "O"; Endotracheal tube was made "O" shape by assistants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First intubation success rate for each between two group	First laryngoscope tries was success using detection of end tidal CO2	Immediately after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First intubation time	After intubation, appearing end tidal CO2 at monitoring	within 60 seconds
Number of attempts	Number of intubation try	From the first tracheal intubation failure to the next successful tracheal intubation
Measured vital sign	Blood pressure in mmHg and heart rate in bpm were recorded immediately before and after intubation.	immediately before intubation and within 5 minites after intubation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Yu-Kyung Bae, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 24, 2020
• Primary Completion (ANTICIPATED): March 31, 2022
• Study Completion (ANTICIPATED): March 31, 2022

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (ACTUAL): August 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): August 20, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: B-2003-603-304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No