Laryngeal DiseaseNCT05198219
Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults
A study testing Ambu® aScope™ 4 Rhinolaryngo and Conventional reusable rhinolaryngoscope in people with Laryngeal Disease, run by Ambu A/S at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laryngeal Disease
- What is being tested?
- Ambu® aScope™ 4 Rhinolaryngo and Conventional reusable rhinolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Jan 2022to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- If the patient has no clear indication for rhino laryngoscopy the procedure should not be conducted.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Ambu A/S
Ballerup Municipality, Capital Region, 2750
Johan Hellgren, MD
Cecilia Emanuelsson, MD
About this study
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.
Read the 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.
- Conditions
- Laryngeal Disease
- Being tested
- Ambu® aScope™ 4 Rhinolaryngo, Conventional reusable rhinolaryngoscope
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu® aScope™ 4 RhinolaryngoDevice
Patient indication following a rhinolaryngoscopy
Conventional reusable rhinolaryngoscopeDevice
Patient indication following a rhinolaryngoscopy
| Study group | Role | What they receive |
|---|---|---|
| Rhinolaryngoscope Ambu® aScope™ 4 Rhinolaryngo | Experimental | All approved procedures performed during the study period. Receives: Device: Ambu® aScope™ 4 Rhinolaryngo |
| Conventional reusable rhinolaryngoscope | Active comparator | All procedures performed during the study period. Receives: Device: Conventional reusable rhinolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Prior to procedure
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: During procedure
Intended device
Conversion rate from the rhinolaryngoscope initially intended for the procedure to another rhinolaryngoscope.
Measured: During procedure
Rate of complications
Rate of complications or issues with the rhinolaryngoscope or associated technologies.
Measured: During procedure
Frequency of procedures
Total number of procedures performed per week compared between experimental arm and active comparator.
Measured: Assessed no more than 48 hours after completed week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start31 Jan 2022
- Primary completion30 Apr 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laryngeal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ambu A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sahlgrenska University Hospital, Skane University Hospital
- Responsible party
- Sponsor
- Investigators
- Johan Hellgren, MD, Principal investigator, Sahlgrenska Universitetssjukhuset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198219
- Sponsor's protocol ID
- HE001
- Status last verified
- Mar 2022
- First submitted
- 5 Nov 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gudnadottir G, Hafsten L, Dahl Travis H, Nielsen K, Hellgren J. Comparison of utility and organizational impact of reusable and single-use rhinolaryngoscopes in a tertiary otorhinolaryngology department. Front Surg. 2024 Oct 7;11:1380571. doi: 10.3389/fsurg.2024.1380571. eCollection 2024.
PubMed 39435392
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults
- ClinicalTrials.gov ID
- NCT05198219
- Acronym / sponsor ID
- HE001
- Conditions
- Laryngeal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ambu A/SIndustry (pharma, biotech, devices)
- Collaborators
- Sahlgrenska University Hospital, Skane University Hospital
- Study start
- 31 Jan 2022 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rhinolaryngoscope Ambu® aScope™ 4 Rhinolaryngo | Experimental | Device: Ambu® aScope™ 4 RhinolaryngoAll approved procedures performed during the study period. |
| Conventional reusable rhinolaryngoscope | Active comparator | Device: Conventional reusable rhinolaryngoscopeAll procedures performed during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- If the patient has no clear indication for rhino laryngoscopy the procedure should not be conducted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambu® aScope™ 4 RhinolaryngoPatient indication following a rhinolaryngoscopy | Device | Rhinolaryngoscope Ambu® aScope™ 4 Rhinolaryngo |
| Conventional reusable rhinolaryngoscopePatient indication following a rhinolaryngoscopy | Device | Conventional reusable rhinolaryngoscope |
Primary outcome
Pre-procedure time from notification of the physician to start of rhinolaryngoscopy.
Time frame: Prior to procedure
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.
16 secondary outcomes
Availability assessed as the time from indication of the need of the rhinolaryngoscopy until the physician leaves to conduct the rhinolaryngoscopy.
Time frame: Prior to procedure
Time from indication for the need of rhinolaryngoscopy until the procedure is completed.
Time frame: Within 24 hours after completion of procedure.
Organisational impact - User preference for type of rhinolaryngoscope assessment of work process.
Time frame: Up to 26 weeks after study completion
Organisational impact - User preference for type of rhinolaryngoscope for workflow.
Time frame: Up to 26 weeks after study completion
Organisational impact - User evaluation for type of rhinolaryngoscope based on time until start of rhinolaryngoscopy.
Time frame: Up to 26 weeks after study completion
Organisational impact - User preference for type of rhinolaryngoscope based on patient/carer involvement in procedure.
Time frame: Up to 26 weeks after study completion
Organisational impact- User preference for type of rhinolaryngoscope based on training requirements and skills.
Time frame: Up to 26 weeks after study completion
Organisational impact - User preference for type of rhinolaryngoscope based on modes of operation
Time frame: Up to 26 weeks after study completion
Organisational impact - User preference for type of rhinolaryngoscope based on vigilance and monitoring methods.
Time frame: Up to 26 weeks after study completion
Organisational impact - User preference for type of rhinolaryngoscope based on working conditions and safety.
Time frame: Up to 26 weeks after study completion
Organisational impact - Hospital management preference for type of rhinolaryngoscope based on budget allocation.
Time frame: Up to 26 weeks after study completion
Organisational impact - User preference for type of rhinolaryngoscope based on logistics.
Time frame: Up to 26 weeks after study completion
Perception of device
Time frame: During procedure
Intended device
Time frame: During procedure
Rate of complications
Time frame: During procedure
Frequency of procedures
Time frame: Assessed no more than 48 hours after completed week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 39435392Gudnadottir G, Hafsten L, Dahl Travis H, Nielsen K, Hellgren J. Comparison of utility and organizational impact of reusable and single-use rhinolaryngoscopes in a tertiary otorhinolaryngology department. Front Surg. 2024 Oct 7;11:1380571. doi: 10.3389/fsurg.2024.1380571. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Hellgren, MD principal investigator
Sahlgrenska Universitetssjukhuset
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu® aScope™ 4 Rhinolaryngo and Conventional reusable rhinolaryngoscope in people with Laryngeal Disease, run by Ambu A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Su Zhang, PhD (+45 20930439, suzh@ambu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-procedure time from notification of the physician to start of rhinolaryngoscopy. (time frame: Prior to procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05198219, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.