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

Not Applicable

• Conditions: Endotracheal Intubation
• Interventions: Other: group "O"

• Registration Number: NCT04520581
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2020-03-24
• Status Verified: 2020-08
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Study First Posted: 2020-08-20
• Last Update Posted: 2020-08-20
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 238

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group "O"	group "O"	Just before the induction of medicine is injected, the assistant makes endotracheal tube into "O" shape.

Primary Outcome Measures

Name	Time	Method
First intubation success rate for each between two group	Immediately after intubation	First laryngoscope tries was success using detection of end tidal CO2

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeongggi-do, Korea, Republic of