The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure

Not Applicable

Completed

• Conditions: Intubation, Intratracheal; Anesthesia, General; Laryngoscopes
• Interventions: Device: direct laryngoscope; Device: the Clarus Video System as a lightwand; Device: the Clarus Video System as a video stylet

• Registration Number: NCT03841890
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

During an emergency endotracheal intubation, rapid sequence induction intubation with cricoid pressure is frequently implemented to prevent aspiration pneumonia. When properly applied, cricoid pressure may not affect glottic view during endotracheal intubation with either a direct laryngoscope or a video laryngoscope. However, the application of cricoid pressure is likely to prolong the intubation time. Limited mouth opening or vulnerable teeth, which often accompany the patients requiring emergency intubation, are the two common factors to deter the intubators from using a laryngoscopic device. Besides, the blade of a laryngoscopic device is often too bulky for a narrow mouth opening, and the blade always bears a level force on upper incisors while the intubator is lifting epiglottis during intubation, which is liable to tooth fracture. In this prospective randomized study, the investigators compare the use of the Clarus Video System and that of direct laryngoscope (Macintosh Laryngoscope) in patients undergoing endotracheal intubation in simulated rapid sequence induction intubation for the primary goals of the first attempt success rate and intubation time.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11-04
• Primary Completion: 2018-04-13
• Study Completion: 2018-04-14
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-13
• Last Update Submitted: 2019-02-13
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Older than 20 years of age
• Scheduled for elective surgery under general anesthesia

Exclusion Criteria

• BMI (Body Mass Index) > 35 kg/m2
• Interincisor distance < 3 cm
• Poor dentition
• Upper airway tumor
• Limited neck mobility
• Pregnancy
• History of difficult tracheal intubation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intubation with direct laryngoscope	direct laryngoscope	-
Intubation with the Clarus Video System as a lightwand	the Clarus Video System as a lightwand	-
Intubation with the Clarus Video System as a video stylet	the Clarus Video System as a video stylet	-

Primary Outcome Measures

Name	Time	Method
The first attempt success rate	After intubation immediately
Intubation time	After intubation immediately	Intubation time was counted from the inserting the device into the patient's mouth to viewing the endotracheal tube into the trachea.

Secondary Outcome Measures

Name	Time	Method
Blood pressure	1 minute and 5 minutes after intubation	Measure blood pressure in millimeter of mercury by non-invasive blood pressure before induction, 1 minute after intubation, and 5 minutes after intubation
Sore throat	On postoperative day 1	Documented by a blinded observer on the next day. Sore throat was graded according to numerical rating scale (NRS): none, NRS = 0; mild, NRS = 1-3; moderate, NRS = 4-6; severe, NRS = 7-10.
Mucosal injury	On postoperative day 1	Documented by a blinded observer on the next day. "Yes" is defined as any oral mucosal lesion reported by participants.
Heart rate	1 minute and 5 minutes after intubation	Measure heart rate in beats per minute by electrocardiography monitor before induction, 1 minute after intubation, and 5 minutes after intubation

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan