Clinical trial NCT03841890: The Clarus Video System and Direct Laryngoscope for Rapid Sequence Induction Intubation With Cricoid Pressure
Official title: The Clarus Video System (Trachway) and Direct Laryngoscope for Endotracheal Intubation With Cricoid Pressure in Simulated Rapid Sequence Induction Intubation: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Intratracheal
Laryngoscopes
Anesthesia, General
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: The first attempt success rate
timeFrame: After intubation immediately
measure: Intubation time
timeFrame: After intubation immediately
Secondary outcomes:
measure: Blood pressure
timeFrame: 1 minute and 5 minutes after intubation
measure: Heart rate
timeFrame: 1 minute and 5 minutes after intubation
measure: Sore throat
timeFrame: On postoperative day 1
measure: Mucosal injury
timeFrame: On postoperative day 1
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: An-Hsun Cho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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