Unrecognized ConditionNCT06661967
Topical Oral Anesthesia Adjuncts in Conventional Intubation on First-Pass Success Rate
A study testing Lidocaine spray in people with Unrecognized Condition, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
Trial summary
This study aims to determine the first-pass success rate in video laryngoscopy and other parameters that topical anesthesia can affect during intubation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unrecognized Condition
- What is being tested?
- Lidocaine spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteThailand
- Study dates
- 25 Oct 2024to 30 Apr 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients in emergency department that have indication for conventional intubation
- Age > 18 yr
Who cannot join
- Patient who undergo RSI
- Patient who falls in cardiac arrest airway algorithm
- Patient who is currently pregnancy
- Known allergy to lidocaine
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Queen Savang Vadhana Memorial Hospital
Chon Buri, Changwat Chon Buri, 20110
Sila Thammongkol, 0853510161, Sila_th@outlook.com
About this study
Official title: Topical Oral Anesthesia Adjuncts in Conventional Intubation: A Randomized Controlled Trial Evaluating the Impact of Topical Oral Anesthesia on First-pass Success Rate
This study aims to determine the first-pass success rate in video laryngoscopy and other parameters that topical anesthesia can affect during intubation.
Read the detailed description
In Thailand, conventional intubation or sedation without paralysis is still the most common method of intubation due to the lack of emergency physicians at primary care centers. A pilot study had shown that topical oral anesthesia can improve the first-pass success rate in conventional intubation by direct laryngoscopy. This study aims to determine the first-pass success rate in video laryngoscopy and other parameters that topical anesthesia can affect during intubation.
- Conditions
- Unrecognized Condition
- Being tested
- Lidocaine spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine sprayDrug
Also called Placebo
Comparison of the success rate of endotracheal intubations between lidocaine spray and placebo
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine spray | Active comparator | Spray lidocaine 10 puffs at oropharynx during preoxygenation if the patient body weight is lower than 60kg, otherwise 15 puffs Receives: Drug: Lidocaine spray |
| Placebo | Placebo comparator | Spray normal saline 10 puffs at oropharynx during preoxygenation if the patient body weight is lower than 60kg, otherwise 15 puffs Receives: Drug: Lidocaine spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-pass success rate
Comparison of the succession rate of endotracheal tube intubation
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start25 Oct 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unrecognized ConditionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The participants are randomized into two groups. The first group receives lidocaine oral spray during preoxygenation while the latter will receive NSS spray as placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661967
- Sponsor's protocol ID
- 017/2567
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Oral Anesthesia Adjuncts in Conventional Intubation: A Randomized Controlled Trial Evaluating the Impact of Topical Oral Anesthesia on First-pass Success Rate
- ClinicalTrials.gov ID
- NCT06661967
- Acronym / sponsor ID
- 017/2567
- Conditions
- Unrecognized Condition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Queen Savang Vadhana Memorial Hospital, ThailandUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 28 Oct 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 study aims to determine the first-pass success rate in video laryngoscopy and other parameters that topical anesthesia can affect during intubation.
Detailed description
In Thailand, conventional intubation or sedation without paralysis is still the most common method of intubation due to the lack of emergency physicians at primary care centers. A pilot study had shown that topical oral anesthesia can improve the first-pass success rate in conventional intubation by direct laryngoscopy. This study aims to determine the first-pass success rate in video laryngoscopy and other parameters that topical anesthesia can affect during intubation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- The participants are randomized into two groups. The first group receives lidocaine oral spray during preoxygenation while the latter will receive NSS spray as placebo.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine spray | Active comparator | Drug: Lidocaine spraySpray lidocaine 10 puffs at oropharynx during preoxygenation if the patient body weight is lower than 60kg, otherwise 15 puffs |
| Placebo | Placebo comparator | Drug: Lidocaine spraySpray normal saline 10 puffs at oropharynx during preoxygenation if the patient body weight is lower than 60kg, otherwise 15 puffs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients in emergency department that have indication for conventional intubation
- Age > 18 yr
Key exclusion criteria (4 listed)
- Patient who undergo RSI
- Patient who falls in cardiac arrest airway algorithm
- Patient who is currently pregnancy
- Known allergy to lidocaine
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 |
|---|---|---|
| Lidocaine sprayAlso: PlaceboComparison of the success rate of endotracheal intubations between lidocaine spray and placebo | Drug | Lidocaine spray, Placebo |
Primary outcome
First-pass success rate
Time frame: 1 Year
Comparison of the succession rate of endotracheal tube intubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine spray in people with Unrecognized Condition, run by Queen Savang Vadhana Memorial Hospital, Thailand at 1 site in Thailand.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 2024. 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 Thailand. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sila Thammongkol (0853510161, Sila_th@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-pass success rate (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2024.