Automatic Oxygen Titration in Patients After SARS-CoV-2 Infection
- Conditions
- Post-COVID19
- Interventions
- Other: Oxygen therapy
- Registration Number
- NCT04849598
- Lead Sponsor
- Schön Klinik Berchtesgadener Land
- Brief 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. 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- acute infection
- cardiovascular diseases that limit physical fitness
- orthopedic diseases preventing the patient from undergoing the walking tests
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ESWT Order A and B Oxygen therapy 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. Stairs Order A and B Oxygen therapy 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. Stairs Order B and A Oxygen therapy 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. ESWT Order B and A Oxygen therapy 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.
- Primary Outcome Measures
Name Time Method Change of oxygen saturation during the endurance shuttle walk Tests Day 2, 3 SpO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
- Secondary Outcome Measures
Name Time Method Change of transcutaneous pCO2 during ESWTs Day 2, 3 tc pCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Change of Endurance time (s) Day 2, 3, 4 Change of Walking Duration during the ESWT and Stair Walking Tests
Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk tests Day 2, 3 pCO2 measured by capillary blood gases taken before and after the ESWT
Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk tests Day 2,3 pO2 measured by capillary blood gases taken before and after the ESWT
Change of heart rate during ESWTs and stair walking tests Day 2, 3, 4 Heart rate measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
Patients preference due to oxygen delivery system Day 3 Patients will be asked to rate their experienced comfort after each ESWT
Change of time to desaturation (SpO2 ≤ 90%) and to severe desaturation (SpO2 ≤ 85%) during ESWTs and Stair Walking Tests Day 2, 3, 4 SpO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) and O2matic Device.
Change of number of stairs Day 4 Change of the number of stairs the patient was able to climb during Stair Walking Tests
Change of respiratory rate during ESWTs Day 2, 3 Respiratory rate measured by ApneaLink Air™
Trial Locations
- Locations (1)
Klinikum Berchtesgadener Land, Schön Kliniken
🇩🇪Schönau a.Königssee, Bavaria, Germany