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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

Tracking Information
First Submitted Date  ICMJE January 7, 2019
First Posted Date  ICMJE January 14, 2019
Last Update Posted Date November 27, 2019
Actual Study Start Date  ICMJE January 7, 2019
Actual Primary Completion Date November 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
Endurance time [ Time Frame: Day 1 and Day 2 ]
Change of Walking Duration during the ESWT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • 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).
  • 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.
  • 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.
  • 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.
  • 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)
  • 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).
  • 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, ...)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients
Official Title  ICMJE Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients - a Randomized Controlled Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE COPD
Intervention  ICMJE 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%.
Study Arms  ICMJE
  • 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
    Intervention: Other: Oxygen therapy
  • 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%
    Intervention: Other: Oxygen therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2019)
55
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 26, 2019
Actual Primary Completion Date November 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03803384
Other Study ID Numbers  ICMJE COPD FreeO2-Study
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Klaus Kenn, Schön Klinik Berchtesgadener Land
Study Sponsor  ICMJE Schön Klinik Berchtesgadener Land
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Klaus Kenn, Prof. Dr. Philipps University Marburg Medical Center
PRS Account Schön Klinik Berchtesgadener Land
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP