An interventional study of Ambu® aScope™ 4 Rhinolaryngo and Conventional reusable rhinolaryngoscope in Laryngeal Disease, sponsored by Ambu A/S. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Ambu A/S · Not applicable, Interventional, and Treatment
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.
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.
136 studies on the registry are indexed under Laryngeal Diseases; 23 are open to participants now.
This study's planned enrollment of 50 is above the median of 41 across 111 interventional studies indexed under Laryngeal Diseases.
Browse Laryngeal Diseases studies →Ambu A/S is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
All approved procedures performed during the study period.
Device: Ambu® aScope™ 4 Rhinolaryngo
All procedures performed during the study period.
Device: Conventional reusable rhinolaryngoscope
Patient indication following a rhinolaryngoscopy
Patient indication following a rhinolaryngoscopy
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.
Time frame: Prior to procedure
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.
Time frame: Prior to procedure
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.
Time frame: Within 24 hours after completion of procedure.
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.
Time frame: Up to 26 weeks after study completion
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.
Time frame: Up to 26 weeks after study completion
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.
Time frame: Up to 26 weeks after study completion
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.
Time frame: Up to 26 weeks after study completion
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.
Time frame: Up to 26 weeks after study completion
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.
Time frame: Up to 26 weeks after study completion
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.
Time frame: Up to 26 weeks after study completion
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.
Time frame: Up to 26 weeks after study completion
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.
Time frame: Up to 26 weeks after study completion
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.
Time frame: Up to 26 weeks after study completion
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).
Time frame: During procedure
Intended device
Conversion rate from the rhinolaryngoscope initially intended for the procedure to another rhinolaryngoscope.
Time frame: During procedure
Rate of complications
Rate of complications or issues with the rhinolaryngoscope or associated technologies.
Time frame: During procedure
Frequency of procedures
Total number of procedures performed per week compared between experimental arm and active comparator.
Time frame: Assessed no more than 48 hours after completed week.
Plan to share: No
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Ambu A/S