Soft Mist Spray Device for Airway Anaesthesia During Awake Videolaryngoscopy (CT2Trachospray)

Rationale:

Effective and fast topical anaesthesia of the upper airway is of paramount importance in awake (conscious) videolaryngoscopy of the airway in order to avoid patient discomfort. Different methods of anesthetizing the airway have been described. Conventional topical airway anaesthesia is not always effective due to non-optimal flow patterns and generation of ineffective local anaesthetic aerosols. Other methods of anaesthetizing the airway are more invasive. In order to optimize topical anaesthesia of the airway a soft mist spray device (Trachospray) for topical anaesthesia of the airway has been developed, in which optimal airflow patterns are obtained and local anaesthetic aerosols are generated which will reach the target zone for anesthetizing the airway.

Objective: In this study, the Trachospray will be used for awake videolaryngoscopy, to evaluate its use, effectiveness and comfort level for patients and anaesthesiologist.

Study design: Interventional study.

Study population: 20 healthy human volunteers, ASA 1, 18-60 years old.

Intervention: Subjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device

Main study parameters/endpoints:

Anaesthesia of the airway as evaluated with successful awake videolaryngoscopy with minimal discomfort for the subject.

Nature and extent of the burden and risks associated with participation:

Risk management on the Trachospray device shows that all user risks are mitigated and no residual risks remain for the use of the device. Testing of the device and the application of the device in daily practice has no additional risks than the present technique of performing anaesthesia of the airways.There may be some discomfort during the procedure, mainly airway irritation which may cause coughing or gag reflex.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Airway
• Intervention / Treatment: Device: Trachospray for awake videolaryngoscopy

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands
    • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18-60 years
• Lean body weight >= 50 kg
• ASA physical status 1

Exclusion Criteria:

• Inability to cooperate with adequate airway assessment,
• History of hepatic, renal and coagulation diseases,
• Respiratory tract pathology
• Pregnancy
• Risk of regurgitation or aspiration
• Allergy to amide type of local anaesthetics
• No written informed consent by subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; Subjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device	Device: Trachospray for awake videolaryngoscopy; Subjects will be asked to inhale 4 ml lidocaine 4% via the Trachospray device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete anaesthesia of the airway as evaluated with successful awake videolaryngoscopy with minimal discomfort for the subject	Discomfort and level of anesthesia will be measured with a numerical rating scale (NRS). 60 / 5.000 Vertaalresultaten So the result will be displayed in whole numbers.	3 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Actual): February 11, 2023
• Study Completion (Actual): February 11, 2023

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 19, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CT2 Trachospray

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