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The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope

The Comparison of the Success Rate of the Endotracheal Intubation Between the Stylet and the Frova With Acute Angled Videolaryngoscope

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03962374
Enrollment
166
Registered
2019-05-24
Start date
2022-06-21
Completion date
2023-06-30
Last updated
2022-12-06

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

Conditions

Anesthesia, General

Brief summary

The purpose of this study is to compare the effect of frova and stylet on the success rate of tracheal intubation when using a video laryngoscope.

Interventions

DEVICEFrova

Frova will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.

DEVICEStylet

Stylet will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

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

Inclusion criteria

* 1\. adult patients aged over 19 years who are undergoing endotracheal intubation for elective surgery. * 2\. Patients who have one of the predictors of difficult intubation such as Mallampati classification 3 or 4, limited the movement of the neck, body mass index less than 35 kg/m2, a distance from the tip of the chin to the thyroid cartilage of less than 6.5 cm, a interincisor distance less than 3.5 cm, inability to protrude of lower incisors over the upper incisors, or a diagnosis of obstructive sleep apnea.

Exclusion criteria

* 1\. Patients receiving emergency surgery * 2\. Pregnant women * 3\. Patients scheduled for oral surgery such as tonsillectomy, vocal cord surgery * 4\. Patients who have a history of ankylosing spondylitis or have a large tumor of 4 cm or more on the tongue and need an awake intubation * 5\. Patients who are at risk of vomiting due to not fasting time

Design outcomes

Primary

MeasureTime frameDescription
Success rate of first attempt of endotracheal intubationfor 10 minutes during anesthetic inductionThe endotracheal intubation will be attempted using stylet or frova according to the randomized group. The success or failure of the attempt will be recorded.

Secondary

MeasureTime frameDescription
time for endotracheal intubationfor 10 minutes during anesthetic inductionTime will be measured from when the blades of the videolaryngoscope pass through the patient's mouth until the end-tidal CO2 is detected.

Countries

South Korea

Contacts

Primary ContactHyun Joo Kim, MD, Ph.D
jjollong@yuhs.ac02-2224-1389

Outcome results

None listed

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