## Protocol Section
### Identification Module
**NCT ID:** NCT06420947

**Brief Title:** Application of Electrically Driven Atomized Surface Anesthesia

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

#### Organization Study ID Info
**ID:** Henan xixi
#### Organization
**Class:** OTHER
**Full Name:** Henan Provincial People's Hospital
### Status Module
#### Completion Date
**Date:** 2022-08-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-05-31

**Type:** ACTUAL

#### Start Date
**Date:** 2021-01-29

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Henan Provincial People's Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Anesthesia, Endotracheal

**Keywords:**

- Lidocaine atomized particles

- Nebulization

- Awake tracheal intubation

- Individual topicalization technique

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 230

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: atomizer

**Label:** Group A

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: atomizer

**Label:** Group B

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Other: atomizer

**Label:** Group C

**Type:** EXPERIMENTAL

#### Arm Group 4

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

**Intervention Names:**

- Other: atomizer

**Label:** Group D

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group A

- Group B

- Group C

- Group D

**Description:** Participants received 2% lidocaine by atomizer.

**Name:** atomizer

**Other Names:**

- a wearable and disposable vibrating mesh nebulizer

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Investigators will record cough score during intubation.

**Measure:** cough score

**Time Frame:** during intubation

#### Secondary Outcomes

**Description:** Investigators will record reaction and discomfort scores during intubation.

**Measure:** reaction and discomfort scores

**Time Frame:** during intubation.

**Description:** endotracheal tube insertion inflation of the tracheal tube cuff systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR)

**Measure:** intraoperative hemodynamic parameters

**Time Frame:** endotracheal tube insertion, inflation of the tracheal tube cuff and 1 minute after endotracheal tube insertion

### Eligibility Module

**Eligibility Criteria:** 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.

-

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 19 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Zhengzhou

**Country:** China

**Facility:** Henan Provincial People's Hospital

**State:** Henan

**Zip:** 450003

#### Overall Officials

**Official 1:**

**Affiliation:** Henan Provincial People's Hospital

**Name:** Jiaqiang Zhang, PHD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M11014

- Name: Lidocaine

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
