Application of Electrically Driven Atomized Surface Anesthesia in ATI in Patients With Predictably Difficult Airway.

NCT ID: NCT06420947

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-05

Study Completion Date

2025-02-05

Brief Summary

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This is a parallel and randomized-controlled clinical study aimed to identify the optimized size of atomized particles of 2% lidocaine that can provide the best topical anesthesia during ATI. To determine the effect of nebulization with different sizes of atomized particles of 2% lidocaine on cough, reaction, and comfort during ATI in patients with predicted difficult airway.

Detailed Description

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Conditions

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Anesthesia, Endotracheal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group A

Participants in the A group received 2% lidocaine by A model atomizer.

Group Type EXPERIMENTAL

atomizer

Intervention Type OTHER

Participants received 2% lidocaine by atomizer.

Group B

Participants in the B group received 2% lidocaine by B model atomizer.

Group Type EXPERIMENTAL

atomizer

Intervention Type OTHER

Participants received 2% lidocaine by atomizer.

Group C

Participants in the C group received 2% lidocaine by C model atomizer.

Group Type EXPERIMENTAL

atomizer

Intervention Type OTHER

Participants received 2% lidocaine by atomizer.

Group D

Participants in the D group received 2% lidocaine by D model atomizer.

Group Type EXPERIMENTAL

atomizer

Intervention Type OTHER

Participants received 2% lidocaine by atomizer.

Interventions

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atomizer

Participants received 2% lidocaine by atomizer.

Intervention Type OTHER

Other Intervention Names

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a wearable and disposable vibrating mesh nebulizer

Eligibility Criteria

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Inclusion Criteria

Patients with distinctly difficult airways:(1) Patients with medical history indicating difficult airways.(2) Patients suffering from severe burn scars.(3) Patients suffering from severe obstructive sleep apnea syndrome.(4)Patients suffering from severe congenital dysplasia.

Patients with suspected difficult airway:

Patients with risk factors underwent a medical history for evaluation:(1)Patients with ankylosing spondylitis.(2) Patients with rheumatoid arthritis.(3)Patients with degenerative osteoarthritis.(4)Patients with epiglottitis. (5)Patients with acromegaly.(6)Patients with morbid obesity.(7)Patients with subglottic stenosis. (8) Patients with enlarged thyroid or tonsils.(9)Patients with mediastinal mass.(10)Patients with throat tumors.

Patients with risk factors underwent a physical examination for evaluation:(1)Patients with BMI \> 26 kg/m2. (2)Patients with Mallampati class 3 or 4. (3)Patients with thyromental distance\<60 mm (corresponding to an average distance of 3 finger breadths).(4)Patients with limited mouth opening with interincisor distance\<30 mm.(5)edentulous patients.(6)When the patient closed his mouth in a natural state, the upper incisor was situated in front of the lower incisor.(7)When the mandible is extended forward, the lower incisors of the patient can not protrude beyond the upper incisors.(8)The patient's jaw exhibits stiffness, with minimal elasticity or presence of a tumor.(9)The patients have a short neck with a thick circumference.(10)The patients are unable to touch their chest wall with their jaw, or extend their neck.(11)The patients's palate shape is either characterized by a high arch or is extremely narrow.

Exclusion Criteria

\-
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Henan Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jiaqiang Zhang, PHD

Role: PRINCIPAL_INVESTIGATOR

Henan Provincial People's Hospital

Locations

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Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status

Countries

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China

References

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Li C, Sun M, Zhang L, Wang G, Lu J, Xie Z, Zhang J. Nebulization with differently sized 2% lidocaine atomized particles in awake tracheal intubation by video laryngoscopy: a proof-of-concept randomized trial. BMC Anesthesiol. 2025 Jul 1;25(1):321. doi: 10.1186/s12871-025-03178-9.

Reference Type DERIVED
PMID: 40596861 (View on PubMed)

Other Identifiers

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Henan xixi

Identifier Type: -

Identifier Source: org_study_id

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