Anesthesia, EndotrachealNCT06420947
Application of Electrically Driven Atomized Surface Anesthesia in ATI in Patients With Predictably Difficult Airway.
A study testing atomizer in people with Anesthesia, Endotracheal, run by Henan Provincial People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Endotracheal
- What is being tested?
- atomizer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2024to 5 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anesthesia, Endotracheal
- Being tested
- atomizer
- Keywords
- Lidocaine atomized particles, Nebulization, Awake tracheal intubation, Individual topicalization technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atomizerOther
Also called a wearable and disposable vibrating mesh nebulizer
Participants received 2% lidocaine by atomizer.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants in the A group received 2% lidocaine by A model atomizer. Receives: Other: atomizer |
| Group B | Experimental | Participants in the B group received 2% lidocaine by B model atomizer. Receives: Other: atomizer |
| Group C | Experimental | Participants in the C group received 2% lidocaine by C model atomizer. Receives: Other: atomizer |
| Group D | Experimental | Participants in the D group received 2% lidocaine by D model atomizer. Receives: Other: atomizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
cough score
Investigators will record cough score during intubation.
Measured: during intubation
Secondary outcomes (2)
reaction and discomfort scores
Investigators will record reaction and discomfort scores during intubation.
Measured: 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)
Measured: endotracheal tube insertion, inflation of the tracheal tube cuff and 1 minute after endotracheal tube insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start5 Sep 2024
- Primary completion30 Jan 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, EndotrachealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiaqiang Zhang, PHD, Principal investigator, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420947
- Sponsor's protocol ID
- Henan xixi
- Status last verified
- Sep 2024
- First submitted
- 12 May 2024
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40596861
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Electrically Driven Atomized Surface Anesthesia to Awake Endotracheal Intubation in Patients With Predictably Difficult Airway.
- ClinicalTrials.gov ID
- NCT06420947
- Acronym / sponsor ID
- Henan xixi
- Conditions
- Anesthesia, Endotracheal
- Keywords
- Lidocaine atomized particles, Nebulization, Awake tracheal intubation, Individual topicalization technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Henan Provincial People's HospitalUniversity, hospital or other
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: atomizerParticipants in the A group received 2% lidocaine by A model atomizer. |
| Group B | Experimental | Other: atomizerParticipants in the B group received 2% lidocaine by B model atomizer. |
| Group C | Experimental | Other: atomizerParticipants in the C group received 2% lidocaine by C model atomizer. |
| Group D | Experimental | Other: atomizerParticipants in the D group received 2% lidocaine by D model atomizer. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 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.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| atomizerAlso: a wearable and disposable vibrating mesh nebulizerParticipants received 2% lidocaine by atomizer. | Other | Group A, Group B, Group C, Group D |
Primary outcome
cough score
Time frame: during intubation
Investigators will record cough score during intubation.
2 secondary outcomes
reaction and discomfort scores
Time frame: during intubation.
intraoperative hemodynamic parameters
Time frame: endotracheal tube insertion, inflation of the tracheal tube cuff and 1 minute after endotracheal tube insertion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2025.
- Derived from this study: PubMed 40596861Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiaqiang Zhang, PHD principal investigator
Henan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing atomizer in people with Anesthesia, Endotracheal, run by Henan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cough score (time frame: during intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06420947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.