NCT05478122: CT2Trachospray

Soft Mist Spray Device for Airway Anaesthesia During Awake Videolaryngoscopy

Completed NA Last updated 21 February 2023

What this trial tests

NA trial testing Trachospray for awake videolaryngoscopy in Airway in 20 participants. Completed in 11 February 2023.

Timeline

25 July 2022

Primary endpoint
11 February 2023

11 February 2023

Quick facts

Lead sponsor	Radboud University Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	25 July 2022
Primary completion	11 February 2023
Estimated completion	11 February 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Trachospray for awake videolaryngoscopy

Conditions studied

• Airway — all drugs for Airway →
• Anesthesia, Local — all drugs for Anesthesia, Local →

Sponsor

Radboud University Medical Center

Who can join

Adults 18 to 60, any sex, with Airway or Anesthesia, Local. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Topical Anaesthesia Using a Soft Mist Spray Device Allows Comfortable Awake Visualisation of the Airway via Self-Videolaryngoscopy in Volunteers.
   Markerink H, van Geffen GJ, Bruhn J. · · 2024 · cited 3× · PMID 38276056 · DOI 10.3390/medicina60010176