Demonstrating the Feasibility of a Novel Oxygen Delivery Device in Responding to Real Time Oxygen Needs (The Right Dose System, RDS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Loma Linda University
- Locations
- 2
- Primary Endpoint
- Exercise time
Study Overview
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.
Detailed Description
Consent will be administered by trained study physicians-each subject will be given the opportunity to read the IRB approved consent form and ask questions before being enrolled in the study. Consenting investigating physicians are all licensed medical doctors in the state of California and will be instructed to determine that the subject is competent before obtaining consent. After questions and concerns are answered, the patient will sign and date the consent form. This process will be witnessed, signed and dated by one of the clinic staff as well as the investigator.
This is a non-blinded study without a placebo group. The investigators will randomize subject assignment to two cohorts with opposing intervention order.
Subject confidentiality will be maintained by all staff. The LLUH Research Protections HIPPA form will be utilized to inform and gain consent of the subject. Data will be maintained in a locked department, in a locked office and in a locked cabinet. All electronic data will be stored on the LLUH network and servers.
Study Design
Background/Rationale for Study:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Exercise time
Time Frame: Day 2
Constant work rate testing
Secondary Outcomes
- Time in targeted oxygen saturation range(Day 2)
- Oxygen utilized during exertion(Day 2)
Investigators
Laren Tan, MD
Assistant Professor of Medicine
Loma Linda University