Incidence of Peri-Intubation Complications with Awake Tracheal IntUbation via Channeled video Laryngoscope; A Bayesian Single Arm Trial.

JRCT ID: jRCT1032240001

Registered date:02/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Critically ill patients who require emergency tracheal intubation
• Date of first enrollment: 12/04/2024
• Target sample size: 30
• Study type: Interventional

Intervention(s)

Anesthetize the throat with a spray of 8%lidocaine (local anesthetic) (standard dose: 8 sprays) and administer 100 mcg of fentanyl (analgesic). Additional use may be permitted if the investigat or deems it necessary, but the total dose of xylocaine spray is 200 mg (25 sprays) with low risk of local anesthetic poisoning, and the dose of fentanyl is less likely to produce a sedative effect. It can be used up to 200 mcg.
Perform conscious tracheal intubation using a channeled video laryngoscope (Airway Scope (Nihon Kohden Industries, Ltd.)).

Outcome(s)

• Primary Outcome: Rate of complications within 30 minutes after endotracheal intubation

Secondary Outcome

1)Initial success rate of tracheal intubation
2)Rate of devices required other than Channeled video laryngoscope
3)Rate of change to tracheal intubation under general anesthesia
4)28-day mortality rate

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients who are judged by a clinician to require urgent endotracheal intubation (within a few hours)
2) Patients aged 18 years or older at the time of in formed consent
3) Patients who have obtained written consent from the patient or their legal representative to participate in this clinical study (*)
(*)Even if it is not possible to obtain written consent in advance, the subject will be included as a research subject only if the subject or his or her legal surrogate is given an oral explanation of the subject and the subject understands the subject. In that case, written consent shall be obtained from either the patient or their legal guardian after receiving the protocol treatment.

Exclude criteria

1) Patient undergoing cardiopulmonary resuscitation
2) Patients with systolic blood pressure less than 90 mmHg without the use of vasopressors
3) Patients with SpO2 less than 80% under 10L/min oxygen.
4) Patients with impaired consciousness with a Glasgow Coma Scale (GCS) score of 12 or less
5) Patients who cannot open their mouth more than 2cm
6) Patients with a history of severe hypersensitivity to lidocaine and fentanyl components
7) Patients who are or may be pregnant, or who are breastfeeding
8) Other patients who are judged to be inappropriate for participation in this study by the research physician (sub-researcher)

Related Information

• Primary Sponsor: Masuda Takahiro