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Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803384
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : November 27, 2019
Sponsor:
Information provided by (Responsible Party):
Klaus Kenn, Schön Klinik Berchtesgadener Land

Study Description
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Brief Summary:
Oxygen therapy is a cornerstone in treating patients with severe chronic obstructive pulmonary disease. Usually, oxygen supplementation is delivered using constant-flow rates. Varying oxygenation levels may occur throughout patients´ changing activity. There is some evidence available that an auto-regulating oxygen flow system (FreeO2), which adjusts the oxygen flow automatically to prevent desoxygenation could be beneficial in comparison to a constant oxygen dose of 2 liter/min during walking. However, these possible benefits are unknown if the FreeO2 is compared to a constant oxygen dose according to the individual prescription. Therefore, the primary aim of this study is to investigate the effects of auto-regulated oxygen flow rates compared to constant oxygen flow rates as prescribed according to international guidelines on walking capacity in patients with COPD.

Condition or disease Intervention/treatment Phase
COPD Other: Oxygen therapy Not Applicable

Detailed Description:

Rationale:

Hypoxemia is frequently observed in COPD and thus can negatively impact exercise tolerance. Supplemental oxygen or long-term oxygen therapy is recommended to ensure that the patient is still able to manage his daily life. Usually, oxygen supplementation is delivered using constant flow rates during day- and nighttime or as needed. However, studies have shown, that auto-regulated oxygen flow systems (FreeO2) may enhance the patients endurance, lower the time in severe hypoxemia and increase the time spent within the SpO2 target range.

Aim of this study is to investigate the effects off an auto-regulated oxygen flow system in hypoxemic COPD patients on the patient´s endurance, the oxygen saturation, the pCO2 blood level as well as on heart rate and breathing frequency compared to the effects off the prescribed constant flow (according to the British Thoracic Society Guidelines for Home Oxygen Use in Adults) during an endurance shuttle walk test (ESWT). Additionally, patients experience, e.g. comfort and Preference of the Oxygen-delivery System will be documented.

Design:

This study is a randomized, controlled cross-over trial. Following an initial incremental shuttle walk test (ISWT) in order to determine the participants individual maximal walking capacity, the participant will perform 2 endurance shuttle walk tests (ESWT) at 85% of the maximal walking rate. In randomized order, the participants will perform one ESWT with constant flow as prescribed and one ESWT with the auto-regulated oxygen flow system.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: The Partcipant and Investigator is blinded to the type of oxygen supply (constant flow or auto-regulated flow).
Primary Purpose: Treatment
Official Title: Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients - a Randomized Controlled Trial
Actual Study Start Date : January 7, 2019
Actual Primary Completion Date : November 26, 2019
Actual Study Completion Date : November 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arms and Interventions
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Arm Intervention/treatment
Experimental: ESWT Order A and B
First Endurance Shuttle walk test (A) with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92% and second Endurance Shuttle walk (B) test with supplemental Oxygen therapy via constant oxygen flow rates
 Other: Oxygen therapy
Oxygen supply during ESWT, once with the prescribed constant oxygen flow and once using an auto-regulated oxygen flow system setting the SpO2 target at 92%.
Experimental: ESWT Order B and A
First Endurance Shuttle walk test (B) with supplemental Oxygen therapy via constant oxygen flow rates and second Endurance Shuttle walk (A) test with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92%
 Other: Oxygen therapy
Oxygen supply during ESWT, once with the prescribed constant oxygen flow and once using an auto-regulated oxygen flow system setting the SpO2 target at 92%.


Outcome Measures
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Primary Outcome Measures :
  1. Endurance time [ Time Frame: Day 1 and Day 2 ]
    Change of Walking Duration during the ESWT


Secondary Outcome Measures :
  1. Change of oxygen saturation during the endurance shuttle walk test. [ Time Frame: Day 1 and Day 2 ]
    SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).

  2. Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%) [ Time Frame: Day 1 and Day 2 ]
    SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) and FreeO2 Device.

  3. Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk test [ Time Frame: Day 1 and Day 2 ]
    pCO2 measured by capillary blood gases taken before and after the ESWT.

  4. Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test [ Time Frame: Day 1 and Day 2 ]
    pO2 measured by capillary blood gases taken before and after the ESWT.

  5. Change of partial pressure of CO2 (pCO2) during endurance shuttle walk test [ Time Frame: Day 1 and Day 2 ]
    pCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)

  6. Change of heart rate during endurance shuttle walk test [ Time Frame: Day 1 and Day 2 ]
    Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).

  7. Change of breathing frequency during endurance shuttle walk test [ Time Frame: Day 1 and Day 2 ]
    Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed, ...)

  8. Patients Preference due to oxygen delivery system [ Time Frame: Day 1 and Day 2 ]
    Patients will be asked to rate their experienced comfort after each ESWT


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GOLD III/ IV
  • Hypoxemia (PaO2<55 mmHg) under roomair conditions (rest or during exercise) or SpO2 <88% during exercise
  • established Long-term oxygen therapy or given indication for a Long-term oxygen therapy
  • Age: 40 to 80 years
  • Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL, Germany)
  • Written informed consent

Exclusion Criteria:

  • Acute Exacerbation of COPD
  • Clinical signs of any acute cardiac comorbidity
  • Not able to walk
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803384


Locations
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Germany
Schoen Klinik Berchtesgadener Land
Schönau Am Königssee, Bayern, Germany, 83471
Sponsors and Collaborators
Schön Klinik Berchtesgadener Land
Investigators
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Principal Investigator: Klaus Kenn, Prof. Dr. Philipps University Marburg Medical Center
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Klaus Kenn, Professor Dr. med. Klaus Kenn, Schön Klinik Berchtesgadener Land
ClinicalTrials.gov Identifier: NCT03803384    
Other Study ID Numbers: COPD FreeO2-Study
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: November 27, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klaus Kenn, Schön Klinik Berchtesgadener Land:
hypoxemia, exercise, oxygen, automatic oxygen-titration