Respiratory Failure Clinical Trial
Official title:
Automated Oxygen Delivery by O2matic to Patients Admitted With an Exacerbation in COPD
The aim of the study is to examine if automated oxygen delivery with O2matic is better than
manually controlled oxygen therapy for patients admitted to hospital with an exacerbation in
Chronic Obstructive Pulmonary Disease (COPD).
O2matic is a closed -loop system based on continuous non-invasive measurement of pulse and
oxygen-saturation that is processed in an algorithm that controls the flow of oxygen to the
patient.
The primary hypothesis is that O2matic increases time within acceptable oxygen-saturation
interval. Secondary hypotheses are that O2matic compared to manual control reduces time with
severe hypoxia (SpO2 < 85 %), hypoxi (SpO2 below intended interval) and hyperoxia (SpO2 above
intended interval).
Closed-loop control of oxygen therapy is described in the literature used for preterm
infants, trauma patients, medical emergency use and patients with COPD. For the latter,
closed-loop therapy has been used for patients admitted to hospital with an exacerbation, for
domiciliary oxygen use and during exercise. O2matic is a closed-loop system that is based on
continuous and non-invasive measurement of pulse, oxygen-saturation and respiratory
frequency. The algorithm in O2matic controls oxygen delivery with the aim of keeping the
saturation within the desired interval, which could be 88-92 % for COPD-patients in
accordance with international guidelines on this topic. Saturation interval can be set for
the individual patients, as can the range of acceptable oxygen-flow. If saturation or
oxygen-flow can't be maintained within the desired intervals an alarm will sound.
All studies on closed-loop systems have shown that this method is better than manually
control by nurse to maintain saturation within the desired interval. Furthermore, some
studies have indicated that closed-loop has the possibility to reduce admission time and to
reduce time spent with oxygen therapy, due to more efficient and fast withdrawal from oxygen
supplementation.
In the present study O2matic will be tested versus manual control, for patients admitted with
an exacerbation in COPD, and in need of supplemental oxygen. During the study the patients
will either have oxygen controlled with O2matic or manually by nursing staff. All patients
will have continuous logging of pulse, oxygen-saturation and oxygen-flow with O2matic, but
only in the O2matic active group, the algorithm will control oxygen-delivery.
The primary hypothesis will be tested, which is that O2matic is better than manual control
for maintaining oxygen-saturation within the desired interval and reducing time with
unintended hypoxia and hyperoxia. For this purpose 20 patients will be included in a
crossover design with 4 hours of O2matic-controlled oxygen treatment and 4 hours with
manually titrated oxygen with a 16 hours washout between periods.
No safety issues has been reported in the literature. Before use O2matic will be approved by
The Danish Medicines Agency, The Ethics Committee in the Capital Region of Denmark and by the
regional Data Protection Board. The study will be conducted according to GCP standards with
independent monitoring. All adverse events and serious adverse events will be monitored and
serious adverse events will be reported to Danish Medicines Agency.
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