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

October 25, 2024 updated by: Queen Savang Vadhana Memorial Hospital, Thailand

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Chonburi
      • Chon Buri, Chonburi, Thailand, 20110
        • Recruiting
        • Queen Savang Vadhana Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine spray
Spray lidocaine 10 puffs at oropharynx during preoxygenation if the patient body weight is lower than 60kg, otherwise 15 puffs
Drug: Lidocaine spray
Comparison of the success rate of endotracheal intubations between lidocaine spray and placebo
Other Names:
  • Placebo
Placebo Comparator: Placebo
Spray normal saline 10 puffs at oropharynx during preoxygenation if the patient body weight is lower than 60kg, otherwise 15 puffs
Drug: Lidocaine spray
Comparison of the success rate of endotracheal intubations between lidocaine spray and placebo
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Savang Vadhana Memorial Hospital, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017/2567

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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