Clinical trial NCT05198219: Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults
Official title: Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laryngeal Disease
Lead sponsor: Ambu A/S
Sponsor class: INDUSTRY
Collaborators: name: Sahlgrenska University Hospital
name: Skane University Hospital
First posted: 2022-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pre-procedure time from notification of the physician to start of rhinolaryngoscopy.
timeFrame: Prior to procedure
Secondary outcomes:
measure: Availability assessed as the time from indication of the need of the rhinolaryngoscopy until the physician leaves to conduct the rhinolaryngoscopy.
timeFrame: Prior to procedure
measure: Time from indication for the need of rhinolaryngoscopy until the procedure is completed.
timeFrame: Within 24 hours after completion of procedure.
measure: Organisational impact - User preference for type of rhinolaryngoscope assessment of work process.
timeFrame: Up to 26 weeks after study completion
measure: Organisational impact - User preference for type of rhinolaryngoscope for workflow.
timeFrame: Up to 26 weeks after study completion
measure: Organisational impact - User evaluation for type of rhinolaryngoscope based on time until start of rhinolaryngoscopy.
timeFrame: Up to 26 weeks after study completion
measure: Organisational impact - User preference for type of rhinolaryngoscope based on patient/carer involvement in procedure.
timeFrame: Up to 26 weeks after study completion
measure: Organisational impact- User preference for type of rhinolaryngoscope based on training requirements and skills.
timeFrame: Up to 26 weeks after study completion
measure: Organisational impact - User preference for type of rhinolaryngoscope based on modes of operation
timeFrame: Up to 26 weeks after study completion
measure: Organisational impact - User preference for type of rhinolaryngoscope based on vigilance and monitoring methods.
timeFrame: Up to 26 weeks after study completion
measure: Organisational impact - User preference for type of rhinolaryngoscope based on working conditions and safety.
timeFrame: Up to 26 weeks after study completion
measure: Organisational impact - Hospital management preference for type of rhinolaryngoscope based on budget allocation.
timeFrame: Up to 26 weeks after study completion
measure: Organisational impact - User preference for type of rhinolaryngoscope based on logistics.
timeFrame: Up to 26 weeks after study completion
measure: Perception of device
timeFrame: During procedure
measure: Intended device
timeFrame: During procedure
measure: Rate of complications
timeFrame: During procedure
measure: Frequency of procedures
timeFrame: Assessed no more than 48 hours after completed week.
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: Ambu A/S
state: Hovedstaden
Study officials:
affiliation: Sahlgrenska Universitetssjukhuset
name: Johan Hellgren, MD
role: PRINCIPAL_INVESTIGATOR
References: