Post-COVID19 Clinical Trial
Official title:
Effects of an Automatic Oxygen Titration vs. Constant Oxygen Flow Rates During Daily Activities in Patients After SARS-CoV-2 Infection
Verified date | November 2021 |
Source | Schön Klinik Berchtesgadener Land |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | August 27, 2021 |
Est. primary completion date | August 27, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Berchtesgadener Land, Schön Kliniken | Schönau a.Königssee | Bavaria |
Lead Sponsor | Collaborator |
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Schön Klinik Berchtesgadener Land |
Germany,
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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. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of oxygen saturation during the endurance shuttle walk Tests | SpO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) | Day 2, 3 | |
Secondary | Change of transcutaneous pCO2 during ESWTs | tc pCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) | Day 2, 3 | |
Secondary | Change of heart rate during ESWTs and stair walking tests | Heart rate measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) | Day 2, 3, 4 | |
Secondary | Change of respiratory rate during ESWTs | Respiratory rate measured by ApneaLink Air™ | Day 2, 3 | |
Secondary | 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. | Day 2, 3, 4 | |
Secondary | Change of Endurance time (s) | Change of Walking Duration during the ESWT and Stair Walking Tests | Day 2, 3, 4 | |
Secondary | 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 | Day 2, 3 | |
Secondary | 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 | Day 2,3 | |
Secondary | Patients preference due to oxygen delivery system | Patients will be asked to rate their experienced comfort after each ESWT | Day 3 | |
Secondary | Change of number of stairs | Change of the number of stairs the patient was able to climb during Stair Walking Tests | Day 4 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05074771 -
At Home REhabilitation and Monitoring of People in poST-covid Condition Through ARc-inTellicare Platform (RESTART/RICOMINCIARE)
|
N/A |