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

Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04520581
• Other study ID #: B-2003-603-304
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2020
• Source: Seoul National University Hospital
• Contact: Yu-Kyung Bae
• Phone: +821057054801
• Email: vansuri27[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endotracheal Intubation

Intervention

Other:
• group "O"
Endotracheal tube was made "O" shape by assistants.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeongggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First intubation success rate for each between two group	First laryngoscope tries was success using detection of end tidal CO2	Immediately after intubation
Secondary	First intubation time	After intubation, appearing end tidal CO2 at monitoring	within 60 seconds
Secondary	Number of attempts	Number of intubation try	From the first tracheal intubation failure to the next successful tracheal intubation
Secondary	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