Clinical and technical evidence

A literature search was carried out for this briefing in accordance with 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 3 studies summarised in this briefing, including 69 adults. The studies include a multicentre randomised controlled trial, an observational study and a multicentre crossover trial.

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

Overall assessment of the evidence

None of the studies reported are based in the NHS. The available evidence is only in people with chronic obstructive pulmonary disease (COPD) and COVID‑19 and is based on a very small number of people.

Further evidence is needed on the use of the device in UK-based settings across a broader range of people requiring supplemental oxygen.

Kofod et al. (2021)

Intervention and comparator

O2matic PRO 100 and fixed-dose oxygen.

Key outcomes

The study included people diagnosed with COPD based on the international criteria (hypoxemic at rest without oxygen supplement, saturation less than 88% and partial pressure of oxygen [PaO2] less than 7.3 kPa [55 mmHg]). The study consisted of 3 separate hospital visits during which 2 different walks were performed, the endurance shuttle walk test (ESWT) or the 6-minute walk test (6MWT). Each walk was performed with both the person's usual fixed oxygen dose and with a variable oxygen dose, automatically titrated. On the first visit, the person also performed the incremental shuttle walk test (ISWT), using their usual prescribed oxygen dose. On the second visit, the patient performed an ESWT on a 10‑metre course twice and in a randomised order, without the usual 2‑minute warm up to avoid exhaustion. The last visit involved the person doing a 6MWT with a fixed dose and automated oxygen titration in a random order. During the ESWT, people walked 10.9 (inter‑quartile range [IQR] 6.5 to 14.9) minutes with automated oxygen compared with 5.5 (IQR 3.3 to 7.9) minutes with a fixed dose. During the 6MWT, people walked an average 291.6 (standard deviation [SD] 67.4) metres with automated oxygen compared with 271.3 (SD 65.1) metres with fixed-dose oxygen. Walking with automated oxygen titration had a statistically significant and clinically important effect on dyspnoea. People walked for a 98% longer time when hypoxemia was reduced with a more well-matched, personalised oxygen treatment.

Strengths and limitations

The double-blind study design and use of standard care as the comparator minimised the risk of bias. The study was done outside the NHS. This limits the translation of these findings in the NHS. One of the investigators and authors of this study is the main inventor of the technology and is the main shareholder in the company (O2matic Ltd).

Hansen et al. (2020)

Intervention and comparator

O2matic PRO 100, no comparator.

Key outcomes

The study measured lung function parameters in 15 people with COVID‑19 having oxygen therapy controlled using O2matic PRO 100. Lung function was severely impaired with forced expiratory volume (FEV1), forced vital capacity (FVC) and peak expiratory flow (PEF) reduced to approximately 50%. The average stay on the ward was 3.2 days and O2matic PRO 100 was used on average for 66 hours, providing 987 hours of observation. O2matic PRO 100 maintained SpO2 in the desired interval for 82.9% of the time. Time with SpO2 more than 2% below the desired interval was 5.1% and time with SpO2 more than 2% above the desired interval was 0.6%.

Strengths and limitations

Some limitations of this study included being a single arm study, small sample size and it was done outside the UK. This limits the generalisation of results to the UK setting.

Hansen et al. (2018)

Intervention and comparator

O2matic PRO 100 and standard manually controlled oxygen.

Key outcomes

People with O2matic PRO 100-controlled treatment were within the SpO2 target interval for 85.1% of the time compared with 46.6% of the time with manually controlled treatment (p<0.001). Time with SpO2 below 85% was 1.3% with O2matic PRO 100 and 17.9% with manual control (p=0.01). Time with SpO2 below the target interval but not below 85% was 9.0% with O2matic PRO 100 and 25.0% with manual control (p=0.002). Time with SpO2 above the target interval was not significantly different between treatments (4.6% compared with 10.5%, p=0.2). People using O2matic PRO 100 expressed high confidence and a sense of safety with automatic oxygen delivery.

Strengths and limitations

The study comparator was standard care. Investigators and people in the study were not blinded. This potentially introduces bias. The study was done outside the NHS. This limits the translation of these findings in the NHS. Two of the authors are co-inventors of the technology.


The company claims the technology will optimise oxygen use and may reduce overall oxygen consumption.

Recent and ongoing studies