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

Incidence of Peri-Intubation Complications with Awake Tracheal IntUbation via Channeled video Laryngoscope in Critically Ill Patients; A Bayesian Si ngle Arm Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032240001
Enrollment
30
Registered
2024-04-02
Start date
2024-04-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically ill patients who require emergency tracheal intubation Respiratory failure

Interventions

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 dee
Awake tracheal intubation

Sponsors

Masuda Takahiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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)

Design outcomes

Primary

MeasureTime frame
Rate of complications within 30 minutes after endotracheal intubation

Secondary

MeasureTime frame
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

Contacts

Public ContactTakahiro Masuda

Institute of Science Tokyo Hospital

tmasicu@tmd.ac.jp+81-3-5803-5959

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026