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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04520581
Enrollment
238
Registered
2020-08-20
Start date
2020-03-24
Completion date
2022-03-31
Last updated
2020-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endotracheal Intubation

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.

Interventions

OTHERgroup O

Endotracheal tube was made O shape by assistants.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
First intubation success rate for each between two groupImmediately after intubationFirst laryngoscope tries was success using detection of end tidal CO2

Secondary

MeasureTime frameDescription
First intubation timewithin 60 secondsAfter intubation, appearing end tidal CO2 at monitoring
Number of attemptsFrom the first tracheal intubation failure to the next successful tracheal intubationNumber of intubation try
Measured vital signimmediately before intubation and within 5 minites after intubationBlood pressure in mmHg and heart rate in bpm were recorded immediately before and after intubation.

Countries

South Korea

Contacts

Primary ContactYu-Kyung Bae
vansuri27@gmail.com+821057054801

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026