Demonstrating the Feasibility of a Novel Oxygen Delivery Device
Withdrawn before enrolling · Not applicable
Conditions studied: Increased Oxygen Demand
In brief
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.
Key facts
- Study ID
- NCT02824211
- Run by
- Loma Linda University
- People needed
- 0
- Starts
- 2018-03-01
- Expected to finish
- 2020-07-01
- Last updated by the study team
- 2020-10-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years old
- Patients currently on home supplemental oxygen
- Ambulatory patients able to exercise on treadmill
You may not qualify if…
- 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
Where it is running
- Loma Linda University — Loma Linda, California, United States
Full record on ClinicalTrials.gov
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