Soft Mist Spray Device for Airway Anaesthesia During Awake Videolaryngoscopy

NCT05478122 | Completed

• 1 other identifier: CT2 Trachospray
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Airway; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Interventional

EXPERIMENTAL

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

Device: Trachospray for awake videolaryngoscopy

Interventions

Trachospray for awake videolaryngoscopy DEVICE

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

Interventional

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

Study Officials

• Geert-Jan van Geffen

  Radboud University Medical Center (Radboudumc)

  PRINCIPAL INVESTIGATOR

• Hielke Markerink

  Radboud University Medical Center (Radboudumc)

  STUDY DIRECTOR

• Jorgen Bruhn

  Radboud University Medical Center (Radboudumc)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 28, 2022
• Study Start: July 25, 2022
• Primary Completion: February 11, 2023
• Study Completion: February 11, 2023
• Last Updated: February 21, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)