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Demonstrating the Feasibility of a Novel Oxygen Delivery Device

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. Identifier: NCT02824211
Recruitment Status : Withdrawn (Was unable to obtain funding)
First Posted : July 6, 2016
Last Update Posted : October 14, 2020
Information provided by (Responsible Party):
Laren Tan, MD, Loma Linda University

Brief Summary:

Purpose: To investigate the feasibility of a new oxygen delivery device, the "Right Dose System" (RDS). It delivers individualized boluses of oxygen during rest and exertion to maintain acceptable oxygen saturations.

The procedures include: Enrollment of 10 patients, who are randomized to either exercise with their oxygen prescription followed by exercise with the RDS, or exercise with the RDS followed by exercise on their oxygen prescription. Randomization will occur on a 1:1 basis. Each set of exercise will be separated by a 30 minute recovery session. Subjects will be adults who are on supplemental oxygen and are able to exercise on a treadmill. Subjects will be above 18 years of age. Subject participation will last approximately 1 month. Subjects will be recruited from the Loma Linda pulmonary clinic and the pulmonary rehabilitation program. Consent will take place in the pulmonary clinic, pulmonary function lab or pulmonary rehabilitation by trained study physicians. If Multi-center: N/A (single center) If Single center or investigator-initiated: 10 subjects will participate in the study.

Condition or disease Intervention/treatment Phase
Increased Oxygen Demand Device: Right Dose System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Demonstrating the Feasibility of a Novel Oxygen Delivery Device in Responding to Real Time Oxygen Needs (The Right Dose System, RDS)
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
Experimental: Right Dose System
Use of automated oxygen titration during exertion
Device: Right Dose System
Automated titration of oxygen system during exertion

Primary Outcome Measures :
  1. Exercise time [ Time Frame: Day 2 ]
    Constant work rate testing

Secondary Outcome Measures :
  1. Time in targeted oxygen saturation range [ Time Frame: Day 2 ]
    Constant work rate testing

  2. Oxygen utilized during exertion [ Time Frame: Day 2 ]
    Constant work rate testing

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 18 years old
  • Patients currently on home supplemental oxygen
  • Ambulatory patients able to exercise on treadmill

Exclusion Criteria:

  • Prior use of an investigational medicinal product and or investigational medical device within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or investigational device.
  • Current Prisoner
  • Known to be pregnant
  • < 18 years old
  • Inability to measure pulse oximetry reliably
  • Patients greater than 300 lbs (weight is not supported by our treadmill).
  • Patients with known pulmonary hypertension

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 identifier (NCT number): NCT02824211

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United States, California
Loma Linda University
Loma Linda, California, United States, 92354
Sponsors and Collaborators
Loma Linda University
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Study Chair: Bryant Nguyen, MD, MS Loma Linda University
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Responsible Party: Laren Tan, MD, Assistant Professor of Medicine, Loma Linda University Identifier: NCT02824211    
Other Study ID Numbers: 5160199
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No