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

Application of Electrically Driven Atomized Surface Anesthesia to Awake Endotracheal Intubation in Patients With Predictably Difficult Airway.

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Endotracheal
• Intervention / Treatment: Other: atomizer

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:(1) refusal to participate in the study; (2) airway bleeding; and (3) known allergies to local anesthetics.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Participants in the A group received 2% lidocaine by A model atomizer.	Other: atomizer; Participants received 2% lidocaine by atomizer.; Other Names: a wearable and disposable vibrating mesh nebulizer
Experimental: Group B; Participants in the B group received 2% lidocaine by B model atomizer.	Other: atomizer; Participants received 2% lidocaine by atomizer.; Other Names: a wearable and disposable vibrating mesh nebulizer
Experimental: Group C; Participants in the C group received 2% lidocaine by C model atomizer.	Other: atomizer; Participants received 2% lidocaine by atomizer.; Other Names: a wearable and disposable vibrating mesh nebulizer
Experimental: Group D; Participants in the D group received 2% lidocaine by D model atomizer.	Other: atomizer; Participants received 2% lidocaine by atomizer.; Other Names: a wearable and disposable vibrating mesh nebulizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cough score	Investigators will record cough score during intubation.	during intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reaction and discomfort scores	Investigators will record reaction and discomfort scores during intubation.	during intubation.
intraoperative hemodynamic parameters	endotracheal tube insertion inflation of the tracheal tube cuff systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR)	endotracheal tube insertion, inflation of the tracheal tube cuff and 1 minute after endotracheal tube insertion

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital
• Investigators: Principal Investigator: Jiaqiang Zhang, PHD, Henan Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): February 5, 2025

Study Registration Dates

• First Submitted: May 12, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 20, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Nebulization; Awake tracheal intubation; Lidocaine atomized particles; Individual topicalization technique
• Other Study ID Numbers: Henan xixi

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No