Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults

Ambu

Status: Unknown

Conditions: Laryngeal Disease

Treatments: Device: Ambu® aScope™ 4 Rhinolaryngo; Device: Conventional reusable rhinolaryngoscope

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05198219

HE001

Details and patient eligibility

About

The aim of this study is to investigate the procedure efficiency, organisational and economic impact, and physician evaluation of the conventional reusable rhino laryngoscope vs. Ambu® aScope™ 4 RhinoLaryngo in procedures conducted distally form the ENT department e.g. in the emergency department (ED), intensive care unit (ICU), ward etc., i.e. consults.

Full description

The aim of this study is to investigate the procedure efficiency, organisational and economic impact, and physician evaluation of the conventional reusable rhinolaryngoscope vs. Ambu® aScope™ 4 RhinoLaryngo in procedures conducted distally from the ENT department e.g. in the emergency department, intensive care unit, ward etc., i.e. consults.

The study will be prospective and randomised until 13 procedures have been performed in each group followed by an assessment of the organisational impact and cost comparison of the two technologies. The investigator will track the time and evaluate the device after each procedure. The organisational impact will be accessed by a questionnaire following the study period. A cost comparison will be enabled via tracking all the processes associated with the rhinolaryngoscopes. After tracking all equipment, time, and utilities will be ascribed a cost.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The investigator has been trained and conducted at least 5 successful training procedures with both the aScope 4 RhinoLaryngo and the reusable rhinolaryngoscope systems.
• The investigator on call for consults must be available to fill out the CRF immediately before and after the procedure.
• The investigator must be dedicated to the study while on call for consults
• Clinical indication and eligible for a rhino laryngoscopy, as judged by the physician
• Patients ≥18 years

Exclusion criteria

• If the patient has no clear indication for rhino laryngoscopy the procedure should not be conducted.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Rhinolaryngoscope Ambu® aScope™ 4 Rhinolaryngo

Experimental group

Description:

All approved procedures performed during the study period.

Treatment:

Device: Ambu® aScope™ 4 Rhinolaryngo

Conventional reusable rhinolaryngoscope

Active Comparator group

Description:

All procedures performed during the study period.

Treatment:

Device: Conventional reusable rhinolaryngoscope