Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement for medtech innovation briefings. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
Three studies reporting relevant clinical outcomes are summarised in this briefing. This comprises 1 prospective single-arm evaluation and 2 surveys. The clinical evidence and its strengths and limitations are summarised in the overall assessment of the evidence.
Overall assessment of the evidence
Mistry et al. (2020)
Study size, design and location
UK-based, non-blinded, prospective, single-arm evaluation and cost comparison analysis, carried out over a 5-day period. The single-use rhinolaryngoscope was used on 200 occasions by a total of 16 investigators.
Key outcomes
The study showed that 68% of investigators thought that the single-use rhinolaryngoscope was 'good' or 'very good', and 85% believed it could successfully replace the reusable rhinolaryngoscope. The study concludes that the single-use Ambu aScope 4 RhinoLaryngo provides a clinically comparable and potentially cost-minimising alternative to reusable rhinolaryngoscopes. Incremental costs of reusable rhinolaryngoscopes compared with single use were £30 and £11 in outpatient clinics and -£4 and -£73 in acute surgical assessment units.
Strengths and limitations
Although the investigators' views were positive, there were no comparisons of clinical or patient data, so it is not possible to state conclusively from the study that single-use rhinolaryngoscopes are better than the reusable rhinolaryngoscopes, without a comparative dataset. The study didn't consider investigators' learning curves or the nasal cavity structures visualised. A low level of compliance suggests that most procedures were not reported, which reduces internal and external validity. Healthcare setting and indication was not recorded on every feedback form. This is an important limitation as functionality of the reusable rhinolaryngoscope may have differed between clinical setting and between indications.
Walczak et al. (2021)
Study size, design and location
An online survey distributed to resident doctors at institutions throughout the US which use a disposable nasopharyngolaryngoscope (NPL; Ambu aScope 4 RhinoLaryngo). Cost analysis was done at a single academic centre. The survey was distributed to 109 resident doctors throughout the country.
Key outcomes
The online survey was completed by 33.9% (37/109) of resident doctors in the US who reported that the single-use Ambu aScope 4 rhinolaryngoscope was comparable to reusable rhinolaryngoscopes in ergonomics and manoeuvrability, inferior in imaging quality, superior in setup, convenient and rated better overall. The survey concluded disposable NPLs may offer an alternative option. Cost analysis favours disposable NPLs as the more cost-effective option.
Strengths and limitations
The main strength of the study was its inclusion of Ambu technology with a direct comparison to reusable NPLs. Limitations of the study include difficulty in distribution of the survey and difficulty in identifying who used the disposable NPL. It was difficult to estimate the cost of certain materials (detergents, acids and machinery for reprocessing) and so this was likely underestimated. There was also no patient data reported.
Becker et al. (2019)
Study size, design and location
Ten consecutive patients requiring rhinolaryngoscopy were examined with Ambu aScope 4 RhinoLaryngo Intervention by 6 different examiners in 18 procedures. Examiners then completed a questionnaire on image quality, manoeuvrability, ergonomics of the handle and overall impression.
Key outcomes
The survey used a 5‑point scale (in which 1 is very poor, 2 is poor, 3 is acceptable, 4 is good, and 5 is very good) and reported that image quality was rated 4.17, manoeuvrability 4.67, ergonomics of the handle 4.44 and overall impression 4.33. A mild nosebleed occurred in 1 procedure. Four out of 6 examiners gave positive feedback about the ease of storing pictures and videos on the monitor. The survey concluded that a flexible single-use rhinolaryngoscope can be a good alternative to conventional systems.
Sustainability
The company claims the technology has a comparable environmental impact to reusable rhinolaryngoscopes. Sørensen et al. (2018) compared the environmental impact of Ambu aScope 4 Broncho with reusable bronchoscopes. The study found that when 1 set of protective wear and disinfection material is used to clean 1 reusable bronchoscope, it has comparable or higher consumption of energy and material, emissions of carbon dioxide equivalents and values of resource consumption than the Ambu aScope 4. Cleaning 2 or more bronchoscopes per set makes the impact more comparable with the Ambu aScope 4.
In addition, Ambu has initiated a plastic-neutral partnership with Plastic Bank. This organisation reprocesses materials for reintroduction into the global manufacturing supply chain.
Recent and ongoing studies
Procedural Efficiency and Organisational Impact of Rhino Laryngoscopes Procedures in Consults. ClinicalTrials.gov identifier: NCT05198219. Status: recruiting. Indication: laryngeal disease. Devices: Ambu aScope 4 RhinoLaryngo. Estimated completion date: September 2022 – results yet to be posted. Country: Denmark.
The company has said that there are non-Ambu affiliated ongoing studies which are yet to be added to ClinicalTrials.gov.