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.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
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%
Klinikum Berchtesgadener Land, Schön Kliniken
Schönau am Königssee, Bavaria, Germany
Change of oxygen saturation during the endurance shuttle walk Tests
SpO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Time frame: Day 2, 3
Change of transcutaneous pCO2 during ESWTs
tc pCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Time frame: Day 2, 3
Change of heart rate during ESWTs and stair walking tests
Heart rate measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Time frame: Day 2, 3, 4
Change of respiratory rate during ESWTs
Respiratory rate measured by ApneaLink Air™
Time frame: Day 2, 3
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.
Time frame: Day 2, 3, 4
Change of Endurance time (s)
Change of Walking Duration during the ESWT and Stair Walking Tests
Time frame: Day 2, 3, 4
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
Time frame: Day 2, 3
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
Time frame: Day 2,3
Patients preference due to oxygen delivery system
Patients will be asked to rate their experienced comfort after each ESWT
Time frame: Day 3
Change of number of stairs
Change of the number of stairs the patient was able to climb during Stair Walking Tests
Time frame: Day 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.