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Completed

NCT Number: NCT04849598

Automatic Oxygen Titration 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.

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Key information

Conditions

Post-COVID19 Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, Bavaria, 83471, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Oxygen therapy

Other

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%

Primary outcomes

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

    Time frame: Day 2, 3

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

Secondary outcomes

  1. Change of transcutaneous pCO2 during ESWTs

    Time frame: Day 2, 3

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

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

    Time frame: Day 2, 3, 4

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

  3. Change of respiratory rate during ESWTs

    Time frame: Day 2, 3

    Respiratory rate measured by ApneaLink Air™

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

    Time frame: Day 2, 3, 4

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

  5. Change of Endurance time (s)

    Time frame: Day 2, 3, 4

    Change of Walking Duration during the ESWT and Stair Walking Tests

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

    Time frame: Day 2, 3

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

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

    Time frame: Day 2,3

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

  8. Patients preference due to oxygen delivery system

    Time frame: Day 3

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

  9. Change of number of stairs

    Time frame: Day 4

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

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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