Intubation, Intratracheal, Laryngoscopes, Anesthesia, General
Conditions
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.
Interventions
DEVICEthe Clarus Video System as a video stylet
video-guided intubation
DEVICEthe Clarus Video System as a lightwand
The endotracheal tube will be initially guided into larynx in the dimly lit operating room by a bright glow moving in the anterior soft tissue of the neck and finally by the image of the trachea rings on the video screen.
DEVICEdirect laryngoscope
Macintosh laryngoscope size 3
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Sore throat and mucosa injury are documented by a blinded observer on the next day.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Countries
Taiwan
Outcome results
None listed