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Post-COVID19NCT04849598

Automatic Oxygen Titration in Patients After SARS-CoV-2 Infection

A study testing Oxygen therapy in people with Post-COVID19, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.

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

With the progression of the SARS-CoV-2 pandemic there's an increasing number of patients recovering from COVID19. Some of these patients still experience hypoxemia and therefore are still in need of a long-term oxygen therapy (LTOT), usually provided as a constant-flow. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post-COVID19
What is being tested?
Oxygen therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteGermany
Study dates
13 Apr 2021to 27 Aug 2021
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

  • validated COVID19 disease in case history
  • hypoxemia (PO2 < 55 mmHg) under room air conditions (rest or during exercise) or SpO2 <88% during exercise
  • already established Long-term oxygen therapy or given indication for a Long-term oxygen therapy

Who cannot join

  • acute infection
  • cardiovascular diseases that limit physical fitness
  • orthopedic diseases preventing the patient from undergoing the walking tests

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Klinikum Berchtesgadener Land, Schön Kliniken

    Schönau am Königssee, Bavaria, 83471

Other trials in Germany

About this study

Official title: Effects of an Automatic Oxygen Titration vs. Constant Oxygen Flow Rates During Daily Activities in Patients After SARS-CoV-2 Infection

With the progression of the SARS-CoV-2 pandemic there's an increasing number of patients recovering from COVID19. Some of these patients still experience hypoxemia and therefore are still in need of a long-term oxygen therapy (LTOT), usually provided as a constant-flow. However, during a patient's daily activities, oxygenation levels may vary and the same constant flow may not be suitable for all tasks. Studies in COPD patients suggest that an automatic oxygen titration, which adjusts the oxygen flow automatically according to a patient's blood oxygen levels to prevent desaturations, could be beneficial compared to a constant oxygen titration during exercise.

So far there are no studies available that directly compare the automatic oxygen titration with the patient's prescribed constant oxygen flow in patients with hypoxemia after SARS-CoV-2 infection during activities of daily life. Therefore, the primary outcome of this study is to investigate the effects of an automatic oxygen titration (O2matic, Denmark) in comparison to constant oxygen flow rates as prescribed according to guidelines.

Read the detailed description

Rationale

After an infection with SARS-CoV-2, some patients still experience hypoxemia even after being discharged from the hospital. Long-term oxygen therapy (LTOT) is then used to increase the patients blood oxygen level and prolong the time spent within the SpO2 target range, decreasing the probability of severe hypoxemia or at least lowering the time spent in this severe hypoxemia and all in all enhance the patient's endurance. A prescription for LTOT is usually given for constant flow rates which might vary during day- and night use.

This study is a randomized, controlled cross-over trial. Its aim is to investigate the effects of an automatic oxygen titration in patients after SARS-CoV-2 infection on the blood oxygen saturation level during activities of daily life (walking). Secondary, the effects of using an automatic titration on endurance, pCO2 blood level as well as heart rate and breathing frequency are compared to using the prescribed constant flow oxygen therapy.

Design:

Each patient undergoes a series of shuttle walk tests. After an initial incremental shuttle walk test (ISWT) to determine the patient's maximum walking speed, the patient undergoes 2 endurance shuttle walk tests (ESWTs) at 85% of the maximum walking speed. One of these ESWTs is performed with the prescribed constant oxygen flow, the other with the O2matic automatic oxygen titration in a random order.

In addition to the shuttle walk tests, patient will perform two stair walking tests, again one with the prescribed constant oxygen flow, the other with the O2matic automatic oxygen titration in a random order.

Furthermore, patients will be asked to rate their experienced comfort after each ESWT and to name their preferred oxygen titration system.

Conditions
Post-COVID19
Being tested
Oxygen therapy
Keywords
post SARS-CoV-2 infection, long-term oxygen therapy, automatic oxygen-titration, hypoxemia
Medical subject headings
Hypoxia

What participants receive

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

  • Oxygen therapyOther

    Oxygen therapy during ESWTs and Stair Walking Test: one test using the prescribed constant oxygen flow and one using an automatic oxygen titration system. SpO2 target range: 90 - 94%

Study groups in NCT04849598
Study groupRoleWhat they receive
ESWT Order A and BExperimentalFirst Endurance Shuttle Walk Test using the automatic oxygen titration (O2matic) with the target range being 90 - 94% SpO2, the second Endurance Shuttle Walk Test using the prescribed constant flow oxygen therapy.
Receives: Other: Oxygen therapy
ESWT Order B and AExperimentalFirst Endurance Shuttle Walk Test using the prescribed constant flow oxygen therapy, the second Endurance Shuttle Walk Test using the automatic oxygen titration (O2matic) with the target range being 90 - 94% SpO2.
Receives: Other: Oxygen therapy
Stairs Order A and BExperimentalFirst Stair Walking Test using the automatic oxygen titration (O2matic) with the target range being 90 - 94% SpO2, the second Stair Walking Test using the prescribed constant flow oxygen therapy.
Receives: Other: Oxygen therapy
Stairs Order B and AExperimentalFirst Stair Walking Test using the prescribed constant flow oxygen therapy, the second Stair Test using the automatic oxygen titration (O2matic) with the target range being 90 - 94% SpO2.
Receives: Other: Oxygen therapy

What is being measured

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

  1. Change of oxygen saturation during the endurance shuttle walk Tests

    SpO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)

    Measured: Day 2, 3

Secondary outcomes (9)

  1. Change of transcutaneous pCO2 during ESWTs

    tc pCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)

    Measured: Day 2, 3

  2. Change of heart rate during ESWTs and stair walking tests

    Heart rate measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)

    Measured: Day 2, 3, 4

  3. Change of respiratory rate during ESWTs

    Respiratory rate measured by ApneaLink Air™

    Measured: Day 2, 3

  4. Change of time to desaturation (SpO2 ≤ 90%) and to severe desaturation (SpO2 ≤ 85%) during ESWTs and Stair Walking Tests

    SpO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) and O2matic Device.

    Measured: Day 2, 3, 4

  5. Change of Endurance time (s)

    Change of Walking Duration during the ESWT and Stair Walking Tests

    Measured: Day 2, 3, 4

  6. Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk tests

    pCO2 measured by capillary blood gases taken before and after the ESWT

    Measured: Day 2, 3

  7. Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk tests

    pO2 measured by capillary blood gases taken before and after the ESWT

    Measured: Day 2,3

  8. Patients preference due to oxygen delivery system

    Patients will be asked to rate their experienced comfort after each ESWT

    Measured: Day 3

  9. Change of number of stairs

    Change of the number of stairs the patient was able to climb during Stair Walking Tests

    Measured: Day 4

Timeline

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

  1. First posted19 Apr 2021
  2. Study start13 Apr 2021
  3. Primary completion27 Aug 2021
  4. Study completion27 Aug 2021

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
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04849598
Sponsor's protocol ID
O2matic_COVID
Status last verified
Nov 2021
First submitted
13 Apr 2021
Last updated
5 Nov 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18.

    PubMed 27794080

  • Singh SJ, Puhan MA, Andrianopoulos V, Hernandes NA, Mitchell KE, Hill CJ, Lee AL, Camillo CA, Troosters T, Spruit MA, Carlin BW, Wanger J, Pepin V, Saey D, Pitta F, Kaminsky DA, McCormack MC, MacIntyre N, Culver BH, Sciurba FC, Revill SM, Delafosse V, Holland AE. An official systematic review of the European Respiratory Society/American Thoracic Society: measurement properties of field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1447-78. doi: 10.1183/09031936.00150414. Epub 2014 Oct 30.

    PubMed 25359356

  • Prieur G, Combret Y, Medrinal C, Arnol N, Bonnevie T, Gravier FE, Quieffin J, Lamia B, Reychler G, Borel JC. Energy conservation technique improves dyspnoea when patients with severe COPD climb stairs: a randomised crossover study. Thorax. 2020 Jun;75(6):510-512. doi: 10.1136/thoraxjnl-2019-214295. Epub 2020 Mar 26.

    PubMed 32217783

Questions about this trial

What is this clinical trial studying?

A study testing Oxygen therapy in people with Post-COVID19, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.

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 3 inclusion and 3 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 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Change of oxygen saturation during the endurance shuttle walk Tests (time frame: Day 2, 3). 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 NCT04849598, which also lists 3 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 5 Nov 2021.

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