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

NCT04849598 | Completed

• 1 other identifier: O2matic_COVID
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-COVID19

Keywords

post SARS-CoV-2 infection; long-term oxygen therapy; automatic oxygen-titration; hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change of transcutaneous pCO2 during ESWTs

  Day 2, 3

• Change of heart rate during ESWTs and stair walking tests

  Day 2, 3, 4

• Change of respiratory rate during ESWTs

  Day 2, 3

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

  Day 2, 3, 4

• Change of Endurance time (s)

  Day 2, 3, 4

Study Arms (4)

ESWT Order A and B

EXPERIMENTAL

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

ESWT Order B and A

EXPERIMENTAL

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

Stairs Order A and B

EXPERIMENTAL

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

Stairs Order B and A

EXPERIMENTAL

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

Interventions

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%

ESWT Order A and B; ESWT Order B and A; Stairs Order A and B; Stairs Order B and A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead

Study Sites (1)

Klinikum Berchtesgadener Land, Schön Kliniken

Schönau am Königssee, Bavaria, 83471, Germany

Location

Related Publications (3)

• Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18.

  PMID: 27794080 BACKGROUND

• 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.

  PMID: 25359356 BACKGROUND

• 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.

  PMID: 32217783 BACKGROUND

MeSH Terms

Conditions

Hypoxia

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Andreas R Koczulla, Prof. Dr. med.

  Philipps University Marburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pneumological Department

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: April 13, 2021
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-11

Locations

DE (1)