NCT06661967

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

October 25, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 28, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

October 28, 2024

Status Verified

October 1, 2024

Enrollment Period

10 months

First QC Date

October 23, 2024

Last Update Submit

October 25, 2024

Conditions

Unrecognized Condition

Outcome Measures

Primary Outcomes (1)

  • First-pass success rate

    Comparison of the succession rate of endotracheal tube intubation

    1 Year

Study Arms (2)

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

Lidocaine sprayDRUG

Comparison of the success rate of endotracheal intubations between lidocaine spray and placebo

Also known as: Placebo
Lidocaine sprayPlacebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Savang Vadhana Memorial Hospital

Chon Buri, Changwat Chon Buri, 20110, Thailand

RECRUITING

Central Study Contacts

Sila Thammongkol

CONTACT

0853510161Sila_th@outlook.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2024

First Posted

October 28, 2024

Study Start

October 25, 2024

Primary Completion

August 31, 2025

Study Completion

April 30, 2026

Last Updated

October 28, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)