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

November 4, 2021 updated by: Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Schönau a.Königssee, Bavaria, Germany, 83471
        • Klinikum Berchtesgadener Land, Schön Kliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ESWT Order A and B
First 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.
Other: Oxygen therapy
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%
Experimental: ESWT Order B and A
First 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.
Other: Oxygen therapy
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%
Experimental: Stairs Order A and B
First 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.
Other: Oxygen therapy
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%
Experimental: Stairs Order B and A
First 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.
Other: Oxygen therapy
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%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Day 2, 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Day 2, 3
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)
Day 2, 3, 4
Change of respiratory rate during ESWTs
Time Frame: Day 2, 3
Respiratory rate measured by ApneaLink Air™
Day 2, 3
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.
Day 2, 3, 4
Change of Endurance time (s)
Time Frame: Day 2, 3, 4
Change of Walking Duration during the ESWT and Stair Walking Tests
Day 2, 3, 4
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
Day 2, 3
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
Day 2,3
Patients preference due to oxygen delivery system
Time Frame: Day 3
Patients will be asked to rate their experienced comfort after each ESWT
Day 3
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
Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Schön Klinik Berchtesgadener Land

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andreas R Koczulla, Prof. Dr. med., Philipps University Marburg Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 27, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • O2matic_COVID

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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