Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults

Laryngeal Disease Clinical Trial

Official title:

Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05198219
• Other study ID #: HE001
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2022
• Source: Ambu A/S
• Contact: Su Zhang, PhD
• Phone: +45 20930439
• Email: suzh[@]ambu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 1, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Laryngeal Disease
• Laryngeal Diseases

Intervention

Device:
• Ambu® aScope™ 4 Rhinolaryngo
Patient indication following a rhinolaryngoscopy
• Conventional reusable rhinolaryngoscope
Patient indication following a rhinolaryngoscopy

Locations

Country	Name	City	State
Denmark	Ambu A/S	Ballerup	Hovedstaden

Sponsors (3)

Lead Sponsor	Collaborator
Ambu A/S	Sahlgrenska University Hospital, Sweden, Skane University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-procedure time from notification of the physician to start of rhinolaryngoscopy.	The time (minutes) from indication of the need for a rhinolaryngoscopy, as registered by the physician until initiation of rhinolaryngoscopy. The mean time registered for the experimental arm will be compared to the active comparator arm to assess differences.	Prior to procedure
Secondary	Availability assessed as the time from indication of the need of the rhinolaryngoscopy until the physician leaves to conduct the rhinolaryngoscopy.	Time (minutes) from indication of the need for rhinolaryngoscopy until the investigator leave to conduct the rhinolaryngoscopy. The mean time registered for the experimental arm will be compared to the mean time registered for the active comparator arm to assess differences.	Prior to procedure
Secondary	Time from indication for the need of rhinolaryngoscopy until the procedure is completed.	Time from indication for the need of rhinolaryngoscopy until the rhinolaryngoscope has been fully removed from the patient.; The outcome will be reported as the area under the curve compared between experimental and active comparator arm.	Within 24 hours after completion of procedure.
Secondary	Organisational impact - User preference for type of rhinolaryngoscope assessment of work process.	User preference assessment of parameters for rhinolaryngoscopy work process (1. Free of wear and tear, 2. Training and education of students, 3. Recording and saving images and videos). Responses rated through 3-point scale - favorable to: 1. Ambu single-use rhinolaryngoscope or 2. conventional reusable rhinolaryngoscope or 3. neutral. Results distributed in percentages.	Up to 26 weeks after study completion
Secondary	Organisational impact - User preference for type of rhinolaryngoscope for workflow.	Comparison between workflows for the experimental arm or active comparator. Assessed as the preference of the treating physician through a 3-point scale - favorable to: 1. Ambu single-use rhinolaryngoscope or 2. conventional reusable rhinolaryngoscope or 3. neutral. Results distributed in percentages.	Up to 26 weeks after study completion
Secondary	Organisational impact - User evaluation for type of rhinolaryngoscope based on time until start of rhinolaryngoscopy.	User evaluation of which rhinolaryngoscope is expected to have the longest time interval from indication for rhinolaryngoscopy until the start of the procedure, based on previous experience.; Response through 3-point scale - favorable to: 1. Ambu single-use rhinolaryngoscope or 2. conventional reusable rhinolaryngoscope or 3. neutral. Results distributed in percentages.	Up to 26 weeks after study completion
Secondary	Organisational impact - User preference for type of rhinolaryngoscope based on patient/carer involvement in procedure.	User assessment of which rhinolaryngoscope is the most cumbersome to involve patients or carers in the procedure and subsequent diagnosis or clinical decision (e.g. show or present the procedure and findings during or following the procedure).; Response through 3-point scale - favorable to: 1. Ambu single-use rhinolaryngoscope or 2. conventional reusable rhinolaryngoscope or 3. neutral. Results distributed in percentages.	Up to 26 weeks after study completion
Secondary	Organisational impact- User preference for type of rhinolaryngoscope based on training requirements and skills.	User preference of training requirement and skills needed from health-care professionals to maneuver rhinolaryngoscope.; Response through 3-point scale - favorable to: 1. Ambu single-use rhinolaryngoscope or 2. conventional reusable rhinolaryngoscope or 3. neutral. Results distributed in percentages.	Up to 26 weeks after study completion
Secondary	Organisational impact - User preference for type of rhinolaryngoscope based on modes of operation	User preference of which rhinolaryngoscope requires most coordination with colleagues to ensure ready-to-use rhinolaryngoscopes.; Response through 3-point scale - favorable to: 1. Ambu single-use rhinolaryngoscope or 2. conventional reusable rhinolaryngoscope or 3. neutral. Results distributed in percentages.	Up to 26 weeks after study completion
Secondary	Organisational impact - User preference for type of rhinolaryngoscope based on vigilance and monitoring methods.	User preference of which rhinolaryngoscope requires the least vigilance and monitoring of high hazard or highly infectious diseases.; Response through 3-point scale - favorable to: 1. Ambu single-use rhinolaryngoscope or 2. conventional reusable rhinolaryngoscope or 3. neutral. Results distributed in percentages.	Up to 26 weeks after study completion
Secondary	Organisational impact - User preference for type of rhinolaryngoscope based on working conditions and safety.	User preference of which rhinolaryngoscope makes the user feel most exposed to infectious agents. Response through 3-point scale - favorable to: 1. Ambu single-use rhinolaryngoscope or 2. conventional reusable rhinolaryngoscope or 3. neutral. Results distributed in percentages.	Up to 26 weeks after study completion
Secondary	Organisational impact - Hospital management preference for type of rhinolaryngoscope based on budget allocation.	Hospital management preference for which rhinolaryngoscope requires the least complex budgeting to ensure patient-ready endoscopes and associated technologies. Response through 3-point scale - favorable to: 1. Ambu single-use rhinolaryngoscope or 2. conventional reusable rhinolaryngoscope or 3. neutral. Results distributed in percentages.	Up to 26 weeks after study completion
Secondary	Organisational impact - User preference for type of rhinolaryngoscope based on logistics.	User preference of which rhinolaryngoscope is associated with the biggest logistical burden. Response through 3-point scale - favorable to: 1. Ambu single-use rhinolaryngoscope or 2. conventional reusable rhinolaryngoscope or 3. neutral. Results distributed in percentages.	Up to 26 weeks after study completion
Secondary	Perception of device	User preference of the image quality, maneuverability, ergonomics of the handle and overall perception of quality of the rhinolaryngoscope will be assessed through a 5-point Likert scale (very poor, poor, acceptable, good or very good).	During procedure
Secondary	Intended device	Conversion rate from the rhinolaryngoscope initially intended for the procedure to another rhinolaryngoscope.	During procedure
Secondary	Rate of complications	Rate of complications or issues with the rhinolaryngoscope or associated technologies.	During procedure
Secondary	Frequency of procedures	Total number of procedures performed per week compared between experimental arm and active comparator.	Assessed no more than 48 hours after completed week.