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

Chang Gung Medical Foundation

Status: Completed

Conditions: Intubation, Intratracheal; Anesthesia, General; Laryngoscopes

Treatments: Device: direct laryngoscope; Device: the Clarus Video System as a video stylet; Device: the Clarus Video System as a lightwand

Study type: Interventional

Funder types: Other

Identifiers

NCT03841890

201601025A3C502

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 3 patient groups

Intubation with the Clarus Video System as a video stylet

Experimental group

Treatment:

Device: the Clarus Video System as a video stylet

Intubation with the Clarus Video System as a lightwand

Experimental group

Treatment:

Device: the Clarus Video System as a lightwand

Intubation with direct laryngoscope

Active Comparator group

Treatment:

Device: direct laryngoscope