Topical Oral Anesthesia Adjuncts in Conventional Intubati... | NCT06661967

Studies
Topical Oral Anesthesia Adjuncts in Conventional Intubation on First-Pass Success Rate

NCT06661967

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Status

Recruiting

Last Update Posted

Oct 28, 2024Actual

Enrollment

110Estimated

Phase

Not Applicable

Conditions

Unrecognized Condition

Interventions

Lidocaine spray

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2024Actual

Primary Completion Date

Aug 31, 2025Estimated

Completion Date

Apr 30, 2026Estimated

First Submitted Date

Oct 23, 2024

First Submission Date that Met QC Criteria

Oct 25, 2024

First Posted Date

Oct 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2024

Last Update Posted Date

Oct 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lidocaine spray	Active Comparator	Spray lidocaine 10 puffs at oropharynx during preoxygenation if the patient body weight is lower than 60kg, otherwise 15 puffs	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	Drug: Lidocaine spray

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine spray	Drug	Comparison of the success rate of endotracheal intubations between lidocaine spray and placebo	Lidocaine spray Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
First-pass success rate	Comparison of the succession rate of endotracheal tube intubation	1 Year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients in emergency department that have indication for conventional intubation
Age > 18 yr

Exclusion Criteria:

Patient who undergo RSI
Patient who falls in cardiac arrest airway algorithm
Patient who is currently pregnancy
Known allergy to lidocaine

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sila Thammongkol	Contact	0853510161		Sila_th@outlook.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Queen Savang Vadhana Memorial Hospital	Recruiting	Chon Buri	Changwat Chon Buri	20110	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided