Application of Electrically Driven Atomized Surface Anesthesia

Anesthesia, Endotracheal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06420947
• Other study ID #: Henan xixi
• Status: Completed
• Phase: N/A
• Start date: January 29, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: May 2024
• Source: Henan Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: August 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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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Related Conditions & MeSH terms

• Anesthesia, Endotracheal

Intervention

Other:
• atomizer
Participants received 2% lidocaine by atomizer.

Locations

Country	Name	City	State
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cough score	Investigators will record cough score during intubation.	during intubation
Secondary	reaction and discomfort scores	Investigators will record reaction and discomfort scores during intubation.	during intubation.
Secondary	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