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

NCT06420947 | Completed

• 1 other identifier: Henan xixi
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia, Endotracheal

Keywords

Lidocaine atomized particles; Nebulization; Awake tracheal intubation; Individual topicalization technique

Outcome Measures

Primary Outcomes (1)

• cough score

  Investigators will record cough score during intubation.

  during intubation

Secondary Outcomes (2)

• reaction and discomfort scores

  during intubation.

• intraoperative hemodynamic parameters

  endotracheal tube insertion, inflation of the tracheal tube cuff and 1 minute after endotracheal tube insertion

Study Arms (4)

Group A

EXPERIMENTAL

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

Other: atomizer

Group B

EXPERIMENTAL

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

Other: atomizer

Group C

EXPERIMENTAL

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

Other: atomizer

Group D

EXPERIMENTAL

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

Other: atomizer

Interventions

atomizer OTHER

Participants received 2% lidocaine by atomizer.

Also known as: a wearable and disposable vibrating mesh nebulizer

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

Study Sites (1)

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Related Publications (1)

• 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.

  PMID: 40596861 DERIVED

MeSH Terms

Interventions

Nebulizers and Vaporizers

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Jiaqiang Zhang, PHD

  Henan Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 20, 2024
• Study Start: September 5, 2024
• Primary Completion: January 30, 2025
• Study Completion: February 5, 2025
• Last Updated: April 22, 2025

Record last verified: 2024-09

Locations

CN (1)