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

Not Applicable

Recruiting

• Conditions: Anesthesia, General
• Interventions: Device: Stylet; Device: Frova

• Registration Number: NCT03962374
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-22
• Study First Submitted QC: 2019-05-22
• Study First Posted: 2019-05-24
• Study Start: 2022-06-21
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-06
• Primary Completion: 2023-05
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 166

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stylet	Stylet	Stylet will be used to facilitate the endotracheal intubation.
Frova	Frova	Frova will be used to facilitate the endotracheal intubation.

Primary Outcome Measures

Name	Time	Method
Success rate of first attempt of endotracheal intubation	for 10 minutes during anesthetic induction	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.

Secondary Outcome Measures

Name	Time	Method
time for endotracheal intubation	for 10 minutes during anesthetic induction	Time will be measured from when the blades of the videolaryngoscope pass through the patient's mouth until the end-tidal CO2 is detected.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of