Clinical and technical evidence

Advice

Published evidence
Overall assessment of the evidence
Sustainability
Recent and ongoing studies

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 mibs@nice.org.uk.

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)

Study size, design and location

Multicentre double-blinded randomised crossover trial in 33 people with COPD on home oxygen in Denmark.

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)

Study size, design and location

Single centre prospective observational study in 15 people with COVID-19 having oxygen in Denmark.

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)

Study size, design and location

Multicentre crossover trial comparing O2matic to manually controlled oxygen in 19 people admitted with COPD in Denmark.

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.

Sustainability

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

Recent and ongoing studies

Effects of an automatic oxygen titration versus constant oxygen flow rates during daily activities in patients after SARS-CoV-2 infection. ClinicalTrials.gov identifier: NCT04849598. Status: completed. Indication: post-COVID‑19. Devices: O2matic. Completion date: 27 August 2021. Country: Germany.
Automated oxygen control by O2matic to patients admitted with acute hypoxemia (O2MATIC-ACUT). ClinicalTrials.gov identifier: NCT04079465. Status: recruiting. Indication: hypoxemic respiratory failure, hypoxia, hypoxemia, respiratory failure, respiratory insufficiency. Devices: O2matic. Estimated completion date: 31 December 2022. Country: Denmark.
Oxygen control and weaning by O2matic to patients admitted with an exacerbation of COPD (O2MATIC-WEAN). ClinicalTrials.gov identifier: NCT03661086. Status: completed. Indication: respiratory failure, hypoxia, hypoxemia, respiratory insufficiency, acute COPD exacerbation. Devices: O2matic. Completion date: June 2022. Country: Denmark.
Automated oxygen titration to patients with COPD and domiciliary long-term oxygen treatment (O2matic HOT). ClinicalTrials.gov identifier: NCT04606290. Status: recruiting. Indication: chronic hypoxemic respiratory failure, COPD. Devices: O2matic. Estimated completion date: 31 December 2022. Country: Denmark.
Does robot-administered oxygen have effect on the perception of dyspnea in patients admitted with COPD and hypoxemia? ClinicalTrials.gov identifier: NCT04370990. Status: unknown. Indication: COPD, hypoxia, Closed-Loop communication, dyspnoea, anxiety, depression. Devices: O2matic. Estimated completion date: September 2022. Country: Denmark.
Is reduced hypoxia through a robot intervention, associated with sensory and emotional descriptions of dyspnea, anxiety, depression, symptom burden and anxiolytics. ClinicalTrials.gov identifier: NCT04375917. Status: unknown. Indication: anxiety, COPD, Closed-Loop communication, dyspnoea, depressive symptoms and hypoxia. Devices: O2matic. Estimated completion date: 1 September 2022. Country: Denmark.