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

Published evidence

There are 4 studies summarised in this briefing. This includes 2 prospective observational studies, 1 retrospective observational study and 1 cross‑sectional study. Studies reporting on Ambu aScope 4 RhinoLaryngo Intervention endoscope are excluded from this briefing.

Further published evidence is available but not summarised in this briefing because it:

The clinical evidence and its strengths and limitations is summarised in the overall assessment of the evidence.

Overall assessment of the evidence

There are too few studies and those available are of low methodological quality and lack patient outcomes. Most studies were done outside the UK. Generalising these findings to the NHS is difficult as product performance and acceptability is very specific to local practice.

Evidence on the use of Ambu aScope 4 Broncho outside the current guidance recommendation in unexpected difficult airways is mainly focused on usability and acceptability of the technology. It would benefit from UK studies reporting clinical and adverse event outcomes.

Singh and Shah (2021)

Intervention and comparator

Ambu aScope 4 BronchoSampler with Ambu aScope 4 Broncho compared to standard sampling methods. Performance of the standard sampling methods was based on operator historical recall.

Key outcomes

The study concluded that the Ambu aScope 4 BronchoSampler was a reliable, effective and potentially safer technique for diagnostic sampling in intensive care. Ambu aScope 4 Broncho Sampler Set minimises aerosolisation which prevents potential risk of occupational exposure to pathogens for healthcare workers.

The setup was much easier in 18 (90%) and easier in 2 (10%) of the procedures because of reduced connection steps using the Broncho Sampler Set. The technology was reported to be intuitive by 18 (90%) of respondents. The mean duration of the procedure to collect 1 sample was 2.5 minutes with a percentage volume of sample retrieved of 54.2%. The overall set up and workflow were much easier in 69% of the 13 intraprocedural connections and easier or as easy as the comparator in the remaining 31% of procedures. Obtaining a sample was reported to be easier in 70%, no different in 20% and worse in 10% of procedures. The ability to protect a sample from start to finish was easier in 95%, and no different in 5% of procedures. Overall, workflow was easier in 18 (90%) and no different in 2 (10%) procedures.

Strengths and limitations

One of the strengths of the study is that it provides a basis for future randomised controlled studies. The major limitation of the study is that it was a single-operator case series and used a small study sample size, which poses a challenge in generalising results. The observational study design is another limitation, as results are prone to selection bias. The comparator was not observed during the study but was only based on the bronchoscopist's perception of their historical experience. This was likely to introduce selection and reporter bias. This study did not report on any clinical outcomes.

Taton et al. (2020)


Ambu aScope 4 Broncho; no comparator was used.

Key outcomes

This study measures the impact of BAL results on patient management and outcome. Therapeutic management in 33 patients (60%) was changed because of the BAL results. Using BAL fluid analysis, non-SARS‑CoV‑2 infection was diagnosed in 23 patients (42%). An alternative diagnosis was provided in 10 patients (18%) out of the 55 patients in the study.

Strengths and limitations

The major strength of this study is it provides evidence of using the Ambu aScope 4 Broncho outside of difficult airways. This was a non-comparative study which was focused more on the added value of BAL than the performance of the technology. The study had a relatively small sample size and was done outside the NHS, which limits generalisation of the findings to the NHS.

Kriege et al. (2020)

Intervention and comparators

Ambu aScope 4 Broncho compared to customary endoscope (both single use and reusable).

Key outcomes

The study assumed equivalent therapeutic performance of the Ambu aScope 4 Broncho compared to customary endoscopes. This study found significant acceptability and preference for Ambu aScope 4 Broncho. The study claimed this could potentially be because of easy manoeuvrability of the scope and optimised visualisation.

A total of 176 Ambu aScope 4 Broncho-aided interventions were evaluated (150 bronchoscopy and 26 intubation). The primary finding of the study was that the Ambu aScope 4 Broncho was preferred over customary endoscopes for both diagnostic and therapeutic bronchoscopy in 58% (86 out of 149) of users and awake intubation with a flexible endoscope in 65% (17 out of 26) of users. Pooled data showed a 59% (103 out of 175) preference in users. In 3 cases (1 in bronchoscopy and 2 in intubation), the physician changed from Ambu aScope 4 Broncho to the customary endoscope to complete the procedure because of insufficient lighting and a defective Ambu aScope 4 video chip.

Secondary outcomes were ease of advancing and navigating the Ambu aScope 4. Up to 87% (130 out of 150) of the users rated the advancing of Ambu aScope 4 as easy or very easy and only 1% (2 out of 150) rated it as difficult. In navigating the Ambu aScope 4, 83% (124 out of 149) of users rated it as easy or very easy and 3% rated it as difficult. Manoeuvrability of the Ambu aScope 4 was rated as easy or very easy by 62% of users compared with 8% for the flexible reusable endoscope.

Strengths and limitations

One of the strengths of this study is that 2 out of 8 study centres, with a study population of 45, were in the UK (Manchester and Edinburgh). But the sample size was small, meaning that generalising findings should be done with caution.

This study was sponsored by Ambu. Participating centres received 180 Ambu aScope 4 Broncho single-use bronchoscopes and 9 aView 2 Advance monitors for study purposes.

Flandes et al. (2020)


Ambu aScope 4 Broncho; no comparator.

Key outcomes

Up to 69.3% of the bronchoscopies were bronchial aspiration and 41.7% were BAL. The median duration of bronchoscopy was 9.1 minutes and the mean score for ease of use, image quality and aspiration quality was 80 out of 100. Bronchoscopists highlighted the portability, immediacy of the Ambu aScope 4 to start the procedure, and possibility of taking and storing images as some of the reasons for their satisfaction. The cumulative sum analysis showed an increase in the average score exceeding 80 out of 100 in more than 80% by the ninth procedure compared with about 70 out of 100 from the first procedure. Learning points noted were: ease of passing the fibre-optic bronchoscope to the trachea (intubation) in the third procedure, ease of manoeuvring during the bronchoscopy in the fourth procedure and image quality during the bronchoscopy in the ninth procedure. There was 46% general satisfaction with the Ambu aScope 4 Broncho.

It was necessary to change the Ambu aScope 4 in about 6% of procedures because of limitations in reaching goals of the procedure and damage to the bronchoscope. Loss of functionality or deterioration during the procedure was reported in 3% of cases. Up to 54.4% of users considered Ambu aScope 4 to have lower image quality than video endoscopes. About 13% of users reported that they would recommend the use of Ambu aScope 4 in only very selected cases, 40% in an acceptable number of cases, 35% in most cases, and 12% reported that they would always use it.

Strengths and limitations

One of the strengths of this study is that it provides evidence of acceptability of using Ambu aScope 4 outside of difficult airway intubation.

The study was not done within the NHS. This limits the generalisation of the results to the NHS. There is potential for selection bias in the recruitment of bronchoscopists. The study did not provide direct comparison with reusable flexible bronchoscopes. This has potential to introduce recall bias.

The study was sponsored by the company. But the sponsor did not participate in the analysis and interpretation of the results.


The company claims that their goal is to design products that enable full recycling. The company states that they contribute to responsible consumption and production by monitoring and reducing their energy and water use. The company has a strategy for reducing the environmental impact of their single-use endoscopes. They have initiated a recycling pilot program of their bronchoscopes in Germany and have plans for a similar programme in the UK. There is no published evidence to support these claims.

Recent and ongoing studies

A Randomised controlled trial to Assess the Safety and Efficiency of a self-Contained sampling device and disposable bronchoscope system versus usual sAmpLing procedure (RASECAL). Trail register identifier: 289572. Status: unknown. Indication: bronchoscopy in intensive care. Devices: Ambu aScope 4 Broncho Sampler Set. Date registered: 15 June 2021. Country: UK.