COPDNCT00484562
Prospective Study Comparing Different Modalities of Oxygen Delivery During Assessment of Functional Exercise Capacity
A study testing Standard oxygen delivery system, Homefill oxygen delivery system and Helios oxygen delivery system in people with COPD, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Objectives: The objective of this study is to determine if any differences exist between the varying modes of portable oxygen delivery systems including liquid oxygen, a portable concentrator, portable devices filled at home from a concentrator, and medical grade compressed oxygen (either an M6 size or D size… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- Standard oxygen delivery system, Homefill oxygen delivery system and Helios oxygen delivery system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Sep 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults (18 years of age and older)
- Current users of prescribed LTOT
- Patients who meet the Category IV classification (Very Severe) of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- Medicare criteria for long-term oxygen therapy (LTOT)
- Exhibit dyspnea on exertion while breathing room air
- No exacerbation of COPD within previous 6 weeks, a resting oxygen saturation of less than 90% on room air (no supplemental oxygen) and receiving LTOT with a pulse-dose generator as prescribed by a physician
Who cannot join
- Children (persons under age 18), fetuses, neonates, pregnant women, prisoners
- Unstable angina during the previous month
- Myocardial infarction during the previous month
- Resting heart rate of > 120
- Systolic blood pressure of >180mmHg
- Diastolic blood pressure of >100 mmHg
- Physical limitations which render the participant unable to walk
Trial locations and contacts
1 site in 1 country.
United States1 site
Harry S Truman Veterans Administration Medical Center
Columbia, Missouri, 65212
About this study
Official title: A Randomized, Multi-arm Repeated Measures Prospective Study Comparing Different Modalities of Portable Oxygen Delivery During Assessment of Functional Exercise Capacity
Objectives:
The objective of this study is to determine if any differences exist between the varying modes of portable oxygen delivery systems including liquid oxygen, a portable concentrator, portable devices filled at home from a concentrator, and medical grade compressed oxygen (either an M6 size or D size cylinder).
Hypothesis:
Patients who are prescribed LTOT will show similar physiologic responses to exercise when using differing modalities of portable oxygen delivery systems.
Read the detailed description
There are over 900,000 individuals currently utilizing Long Term Oxygen Therapy (LTOT) in this country. LTOT is administered by using one or a combination of three basic delivery systems: compressed gas cylinder, liquid oxygen system, and oxygen concentrator. Each of the base oxygen delivery systems has unique advantages and disadvantages regarding operation, function, and cost.
The majority of LTOT users require oxygen during ambulation. Within the home this is accomplished by a 20-50-foot extension tubing. Extending the length of the tubing allows the user (patient) to ambulate up to the extended distance from the base oxygen delivery system. Limitations are of course, the distance, becoming entangled in the tubing and it is not conducive for short trips such as to the mailbox.
Ambulation outside the home, however, requires the use of a "portable oxygen system". Put simplistically, portable oxygen systems are miniaturized versions of the base systems. Here also, each particular delivery system has inherent advantages and disadvantages.
An important development in portable oxygen systems has been the advent of pulse-dose technology. Pulse-dose technology allows both the gaseous and liquid portable systems to conserve oxygen delivery. During the inspiratory phase of breathing a solenoid control valve opens "dosing" a bolus of gas flow through the cannula. Unlike traditional continuous-flow cannula, where oxygen is delivered during both the inspiratory and expiratory cycle, pulse-dose technology only delivers oxygen during in an inspiratory phase of breathing. Oxygen flow that is delivered only during inspiration results in less total oxygen consumption. This in-turn allows relatively small portable oxygen systems to be more efficient and last longer. Such efficiency is not only important to the patient, but also to the Home Medical Equipment (HME) provider. Portable oxygen systems that incorporate pulse-dose technology typically decrease the home visits required to deliver to replenish the patient's oxygen supply.
One portable technology allows the patient to refill small oxygen devices in their home, but uses electricity (battery or AC) for functionality, providing economic hardship for some patients who are prescribed LTOT. Another portable technology is an actual portable oxygen concentrator that is lightweight and operates on electricity as well.
By comparison, the oxygen delivered to patients by HME providers, in either cylinder or liquid form, is an indirect product of liquefaction of air. Stringent FDA repackaging production and transfilling processes must be met. Strength and purity testing requires such "medical grade" oxygen be at least 99.5% pure. Such medical grade oxygen containers typically result in 100% oxygen being provided to the participant.
- Conditions
- COPD
- Being tested
- Standard oxygen delivery system, Homefill oxygen delivery system, Helios oxygen delivery system, FreeStyle oxygen system
- Keywords
- oxygen, COPD, exercise
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard oxygen delivery systemDevice
Standard oxygen tank with pulse dose regulator
Homefill oxygen delivery systemDevice
Homefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit.
Helios oxygen delivery systemDevice
Liquid oxygen portable system pre-filled from a larger liquid oxygen tank
FreeStyle oxygen systemDevice
portable battery-powered oxygen concentrator delivery system
| Study group | Role | What they receive |
|---|---|---|
| Standard oxygen delivery system | Active comparator | Standard oxygen tank with pulse dose regulator Receives: Device: Standard oxygen delivery system |
| Homefill oxygen delivery system | Active comparator | Homefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit. Receives: Device: Homefill oxygen delivery system |
| Helios oxygen delivery system | Active comparator | Liquid oxygen portable system pre-filled from a larger liquid oxygen tank Receives: Device: Helios oxygen delivery system |
| FreeStyle oxygen system | Active comparator | portable battery-powered oxygen concentrator delivery system Receives: Device: FreeStyle oxygen system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of ability to maintain adequate oxygenation
Measured: course of study: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study startMay 2006
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Tyco Healthcare Group
- Responsible party
- Sponsor
- Investigators
- Shawna L Strickland, MEd, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484562
- Sponsor's protocol ID
- 060507
- Status last verified
- Oct 2016
- First submitted
- 7 Jun 2007
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multi-arm Repeated Measures Prospective Study Comparing Different Modalities of Portable Oxygen Delivery During Assessment of Functional Exercise Capacity
- ClinicalTrials.gov ID
- NCT00484562
- Acronym / sponsor ID
- 060507
- Conditions
- COPD
- Keywords
- oxygen, COPD, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Collaborators
- Tyco Healthcare Group
- Study start
- May 2006
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 11 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
The objective of this study is to determine if any differences exist between the varying modes of portable oxygen delivery systems including liquid oxygen, a portable concentrator, portable devices filled at home from a concentrator, and medical grade compressed oxygen (either an M6 size or D size cylinder).
Hypothesis:
Patients who are prescribed LTOT will show similar physiologic responses to exercise when using differing modalities of portable oxygen delivery systems.
Detailed description
There are over 900,000 individuals currently utilizing Long Term Oxygen Therapy (LTOT) in this country. LTOT is administered by using one or a combination of three basic delivery systems: compressed gas cylinder, liquid oxygen system, and oxygen concentrator. Each of the base oxygen delivery systems has unique advantages and disadvantages regarding operation, function, and cost.
The majority of LTOT users require oxygen during ambulation. Within the home this is accomplished by a 20-50-foot extension tubing. Extending the length of the tubing allows the user (patient) to ambulate up to the extended distance from the base oxygen delivery system. Limitations are of course, the distance, becoming entangled in the tubing and it is not conducive for short trips such as to the mailbox.
Ambulation outside the home, however, requires the use of a "portable oxygen system". Put simplistically, portable oxygen systems are miniaturized versions of the base systems. Here also, each particular delivery system has inherent advantages and disadvantages.
An important development in portable oxygen systems has been the advent of pulse-dose technology. Pulse-dose technology allows both the gaseous and liquid portable systems to conserve oxygen delivery. During the inspiratory phase of breathing a solenoid control valve opens "dosing" a bolus of gas flow through the cannula. Unlike traditional continuous-flow cannula, where oxygen is delivered during both the inspiratory and expiratory cycle, pulse-dose technology only delivers oxygen during in an inspiratory phase of breathing. Oxygen flow that is delivered only during inspiration results in less total oxygen consumption. This in-turn allows relatively small portable oxygen systems to be more efficient and last longer. Such efficiency is not only important to the patient, but also to the Home Medical Equipment (HME) provider. Portable oxygen systems that incorporate pulse-dose technology typically decrease the home visits required to deliver to replenish the patient's oxygen supply.
One portable technology allows the patient to refill small oxygen devices in their home, but uses electricity (battery or AC) for functionality, providing economic hardship for some patients who are prescribed LTOT. Another portable technology is an actual portable oxygen concentrator that is lightweight and operates on electricity as well.
By comparison, the oxygen delivered to patients by HME providers, in either cylinder or liquid form, is an indirect product of liquefaction of air. Stringent FDA repackaging production and transfilling processes must be met. Strength and purity testing requires such "medical grade" oxygen be at least 99.5% pure. Such medical grade oxygen containers typically result in 100% oxygen being provided to the participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard oxygen delivery system | Active comparator | Device: Standard oxygen delivery systemStandard oxygen tank with pulse dose regulator |
| Homefill oxygen delivery system | Active comparator | Device: Homefill oxygen delivery systemHomefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit. |
| Helios oxygen delivery system | Active comparator | Device: Helios oxygen delivery systemLiquid oxygen portable system pre-filled from a larger liquid oxygen tank |
| FreeStyle oxygen system | Active comparator | Device: FreeStyle oxygen systemportable battery-powered oxygen concentrator delivery system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Adults (18 years of age and older)
- Current users of prescribed LTOT
- Patients who meet the Category IV classification (Very Severe) of the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
- Medicare criteria for long-term oxygen therapy (LTOT)
- Exhibit dyspnea on exertion while breathing room air
Key exclusion criteria (7 listed)
- Children (persons under age 18), fetuses, neonates, pregnant women, prisoners
- Unstable angina during the previous month
- Myocardial infarction during the previous month
- Resting heart rate of > 120
- Systolic blood pressure of >180mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard oxygen delivery systemStandard oxygen tank with pulse dose regulator | Device | Standard oxygen delivery system |
| Homefill oxygen delivery systemHomefill oxygen delivery system, pre-filled from a larger oxygen concentrator base unit. | Device | Homefill oxygen delivery system |
| Helios oxygen delivery systemLiquid oxygen portable system pre-filled from a larger liquid oxygen tank | Device | Helios oxygen delivery system |
| FreeStyle oxygen systemportable battery-powered oxygen concentrator delivery system | Device | FreeStyle oxygen system |
Primary outcome
Determination of ability to maintain adequate oxygenation
Time frame: course of study: 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
- Individual participant dataSharing planned: No
Related trials for COPD
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
RecruitingPhase 2
Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD
Chronic Obstructive Pulmonary Disease
Recruiting
Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD
COPD, Chronic Obstructive Pulmonary Disease
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Comparison of Several Oxygenation Targets With Different Oxygen Interfaces - Impact on Oxygen Flow Rates
Oxygen Toxicity, COPD Bronchitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shawna L Strickland, MEd principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard oxygen delivery system, Homefill oxygen delivery system and Helios oxygen delivery system in people with COPD, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of ability to maintain adequate oxygenation (time frame: course of study: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.