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Hypoxemic Respiratory FailureO2MATIC-ACUTNCT04079465

Automated Oxygen Control by O2matic to Patients Admitted With Acute Hypoxemia

A study testing O2matic in people with Hypoxemic Respiratory Failure and Hypoxia, run by Hvidovre University Hospital at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to examine if automated oxygen delivery with O2matic allows for faster weaning from oxygen supply and better oxygen control than manually controlled oxygen therapy for patients admitted to the emergency department with acute hypoxemia. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypoxemic Respiratory Failure, Hypoxia, Hypoxemia
What is being tested?
O2matic
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesDenmark
Study dates
1 Oct 2019to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Admission with hypoxemic respiratory failure
  • Age >= 18 years
  • Expected duration of admission > 24 hours
  • Need for oxygen supplementation to maintain SpO2 >= 88 % (patients at risk of hypercapnia) or SpO2 >= 94 % (other patients)
  • Cognitively able to participate in the study
  • Willing to participate and give informed consent

Who cannot join

  • Need or anticipated need for mechanical ventilation (intermittent Continuous Positive Airway Pressure (CPAP) is allowed)
  • Patients with CO-poisoning or other condition with unreliable SpO2.
  • Patients in need of oxygen supplementation at more than 10 liters/min
  • Pregnancy
  • Cognitive or language barriers for participation

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • Amager Hospital

    Copenhagen, 2300

  • Hvidovre Hospital

    Hvidovre, 2650

Other trials in Denmark

About this study

The aim of this study is to examine if automated oxygen delivery with O2matic allows for faster weaning from oxygen supply and better oxygen control than manually controlled oxygen therapy for patients admitted to the emergency department with acute hypoxemia. Furthermore it will be tested if O2matic compared to manual control allows for earlier discharge.

Read the detailed description

Closed-loop control of oxygen therapy is described in the literature used for preterm infants, trauma patients, medical emergency use, and for patients with Chronic Obstructive Pulmonary Disease (COPD). O2matic is a closed-loop system that is based on continuous and non-invasive measurement of pulse rate and oxygen-saturation (SpO2). The algorithm in O2matic controls oxygen delivery with the aim of keeping the SpO2 within the desired interval, which could be 88-92 % for patients at risk of hypercapnia or 94-98 % for patients with pneumonia, asthma exacerbation, heart failure and other medical emergencies, according to guidelines from British Thoracic Society (BTS). SpO2-interval can be set for the individual patients, as can the range of acceptable oxygen-flow. If SpO2 or oxygen-flow cannot 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 faster withdrawal from oxygen supplementation.

In the present study O2matic will be tested versus manual control, for patients admitted to the emergency department with acute hypoxemia due to any reason, except for carbon monoxide (CO) poisoning and other conditions where SpO2 is not a reliable measure of hypoxemia. During the study the patients will either have oxygen controlled with O2matic or manually by nursing staff for 24 hours or until discharge or weaning from oxygen supply. All patients will have continuous logging of pulse rate, oxygen-saturation and oxygen-flow with O2matic, but only in the O2matic active group, the algorithm will control oxygen-delivery.

The primary hypothesis is that O2matic compared to manual control allows for faster weaning from oxygen supplementation, and that more patients will be weaned from oxygen supplementation within a time frame of 24 hours. Furthermore it will be tested if O2matic compared to manual control allows for earlier hospital discharge. It will be tested if O2matic is better than manual control in maintaining oxygen-saturation within the desired interval and reducing time with unintended hypoxia and hyperoxia.

No safety issues has been reported in the literature. O2matic is approved in Europe with "Conformité Européenne" (CE) mark, and approved for clinical testing 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 Good Clinical Practice (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.

Being tested
O2matic
Keywords
closed-loop, oxygen treatment
Medical subject headings
Respiratory Insufficiency, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • O2maticDevice

    O2matic controls oxygen supply with a closed-loop feedback from a pulse oximeter. The aim is to maintain SpO2 within a predefined target interval according to guidelines for the specific condition causing hypoxemia, with the lowest possible supplementation of oxygen.

Study groups in NCT04079465
Study groupRoleWhat they receive
O2maticActive comparatorUsual care plus O2matic controlled oxygen therapy for a maximum of 24 hours or until weaning from oxygen supplementation
Receives: Device: O2matic
ManualNo interventionUsual care plus manual controlled oxygen therapy by nursing staff. O2matic is used in monitoring mode to measure SpO2 continuously.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Probability of weaning from oxygen within 24 hours

    Fraction of patients weaned from oxygen supplementation within 24 hours

    Measured: 24 hours

Secondary outcomes (6)

  1. Probability of weaning from oxygen within 12 hours

    Fraction of patients weaned from oxygen supplementation within 12 hours

    Measured: 12 hours

  2. Duration of admission

    Time from admission to emergency department to discharge from hospital

    Measured: 30 days

  3. Time within SpO2 target interval

    Fraction of time within prescribed SpO2 interval in O2matic and manual arm

    Measured: 24 hours

  4. Time with minor hypoxemia

    Fraction of time with SpO2 at 1 to 3 percentage points below target interval

    Measured: 24 hours

  5. Time with severe hypoxemia

    Fraction of time with SpO2 at 4 or more percentage points below target interval

    Measured: 24 hours

  6. Time with hyperoxia

    Fraction of time with SpO2 above target interval in O2matic and manual arm

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start1 Oct 2019
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open label randomized controlled parallel study
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04079465
Sponsor's protocol ID
O2MATIC-ACUTE
Acronym
O2MATIC-ACUT
Status last verified
Oct 2024
First submitted
3 Sep 2019
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • O'Driscoll BR, Howard LS, Earis J, Mak V. British Thoracic Society Guideline for oxygen use in adults in healthcare and emergency settings. BMJ Open Respir Res. 2017 May 15;4(1):e000170. doi: 10.1136/bmjresp-2016-000170. eCollection 2017. No abstract available.

    PubMed 28883921

  • Cornet AD, Kooter AJ, Peters MJ, Smulders YM. The potential harm of oxygen therapy in medical emergencies. Crit Care. 2013 Apr 18;17(2):313. doi: 10.1186/cc12554.

    PubMed 23635028

  • Chu DK, Kim LH, Young PJ, Zamiri N, Almenawer SA, Jaeschke R, Szczeklik W, Schunemann HJ, Neary JD, Alhazzani W. Mortality and morbidity in acutely ill adults treated with liberal versus conservative oxygen therapy (IOTA): a systematic review and meta-analysis. Lancet. 2018 Apr 28;391(10131):1693-1705. doi: 10.1016/S0140-6736(18)30479-3. Epub 2018 Apr 26.

    PubMed 29726345

  • Hansen EF, Hove JD, Bech CS, Jensen JS, Kallemose T, Vestbo J. Automated oxygen control with O2matic(R) during admission with exacerbation of COPD. Int J Chron Obstruct Pulmon Dis. 2018 Dec 14;13:3997-4003. doi: 10.2147/COPD.S183762. eCollection 2018.

    PubMed 30587955

Questions about this trial

What is this clinical trial studying?

A study testing O2matic in people with Hypoxemic Respiratory Failure and Hypoxia, run by Hvidovre University Hospital at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Probability of weaning from oxygen within 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04079465, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

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