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

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03962374
• Other study ID #: 4-2019-0289
• Status: Recruiting
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: June 2023

Study information

• Verified date: December 2022
• Source: Yonsei University
• Contact: Hyun Joo Kim, MD, Ph.D
• Phone: 02-2224-1389
• Email: jjollong[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of first attempt of endotracheal intubation	The endotracheal intubation will be attempted using stylet or frova according to the randomized group. The success or failure of the attempt will be recorded.	for 10 minutes during anesthetic induction
Secondary	time for endotracheal intubation	Time will be measured from when the blades of the videolaryngoscope pass through the patient's mouth until the end-tidal CO2 is detected.	for 10 minutes during anesthetic induction