Clinical trial NCT04520581: The Use of "O" Shaped- Endotracheal Tube During Intubation for General Anesthesia: Prospective Randomized Trial
Official title: The Use of "O" Shaped- Endotracheal Tube During Intubation for General Anesthesia: Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endotracheal Intubation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 238
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: First intubation success rate for each between two group
timeFrame: Immediately after intubation
Secondary outcomes:
measure: First intubation time
timeFrame: within 60 seconds
measure: Number of attempts
timeFrame: From the first tracheal intubation failure to the next successful tracheal intubation
measure: Measured vital sign
timeFrame: immediately before intubation and within 5 minites after intubation
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeongggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Yu-Kyung Bae
role: PRINCIPAL_INVESTIGATOR
References: