Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institute for Rehabilitation Research and Development, The Ottawa Hospital Rehabilitation Centre | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Background: Portable oxygen concentrators (POCs) featuring the latest integrated oxygen conserving devices (OCDs) provide greater patient accessibility and mobility during ambulation and travel. Recent POCs are compact, lightweight, battery-operated, and require no refill-time, thus meeting patients' clinical and lifestyle needs. There is, however, a lack of research on the clinical performance of the latest POCs that could help to determine their ability to maintain patients' oxygen saturations ≥ 90 % during exercise.
Aim: The purpose of this study is to compare the ability of three POCs, with maximum oxygen production capabilities of 950 to 3000 ml per minute, to maintain oxygen saturations ≥ 90 % in patients with chronic lung disease during exercise.
Method: Six minute walk tests (6-MWTs) will be administered in order to measure oxygen saturations by pulse oximetry (SpO2) in up to 20 patients with a diagnosis of either Chronic Obstructive Pulmonary Disease (COPD), or Pulmonary Fibrosis (PF) with documented exertional oxygen desaturations of ≤ 85% on room air. All participants will participate in 4 different 6-minute walk tests: the first will be a control walk performed with the participants' current oxygen system set at their prescribed exertional flow rate. Then, the participants will perform a walk test with each of the three POCs set at the units' maximum pulse dose setting. The order in which the participants use the POCs will be randomly assigned using a sequence generator.
Hypothesis: It is hypothesized that all three POCs will provide oxygen saturations ≥ 90 % during exercise in patients with chronic lung disease with moderate to severe exertional oxygen desaturation.
Participants will attend two study sessions. During the session 1 participants will perform a 6-minute walk test on room air oxygen to assess their suitability for the study. Only those participants with documented exertional oxygen desaturations of ≤ 85% as measured by pulse oximetry during this walk will be asked to return for the second session. During session 2 participants will perform a further four 6-minute walk tests spread over a morning and afternoon testing session. All all data for primary and secondary outcomes will be measured at session 2.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eclipse 3 portable oxygen concentrator | Experimental | Use of the Eclipse 3 portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test. |
|
| iGo portable oxygen concentrator | Experimental | Use of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test. |
|
| EverGo portable oxygen concentrator | Experimental | Use of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test. |
|
| Control portable oxygen concentrator | No Intervention | 6-minute walk test completed using each patient's own oxygen delivery system set at their usual oxygen prescription for exercise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eclipse 3 portable oxygen concentrator | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in saturation of oxygen in the blood after a 6-minute walk test | For patient safety oxygen saturation was monitored throughout each 6-minute walk test using pulse oximetry. Pre- and post-walk values were captured as the primary outcome measure. | During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests |
| Measure | Description | Time Frame |
|---|---|---|
| Total distance walked | During study session 2: immediately after finishing (post-) each of four 6-minute walk tests | |
| Change in Dyspnea ratings after a 6-minute walk test | Measured with the modified 10-point Borg scale |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lyne Lavallée, BSc(PT) | The Ottawa Hospital Rehabilitation Centre | Principal Investigator |
| Carole Leblanc, RRT | The Ottawa Hospital Rehabilitation Centre | Principal Investigator |
| Doug McKim, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital Rehabilitation Centre | Ottawa | Ontario | K1H 8M2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23550171 | Derived | Leblanc CJ, Lavallee LG, King JA, Taylor-Sussex RE, Woolnough A, McKim DA. A comparative study of 3 portable oxygen concentrators during a 6-minute walk test in patients with chronic lung disease. Respir Care. 2013 Oct;58(10):1598-605. doi: 10.4187/respcare.02275. Epub 2013 Apr 2. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 8, 2025 | |
| Reset | Jul 25, 2025 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| EverGo portable oxygen concentrator | Device |
|
|
| iGo portable oxygen concentrator | Device |
|
|
| During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests |
| Patient preference ratings | Measured using a self-report questionnaire where patients were asked to indicate how much they agreed with statements about the device they had just used. | During study session 2: immediately after finishing (post-) each of four 6-minute walk tests |
| Walk time spent with oxygen saturation greater than or equal to 90% | During study session 2: immediately after finishing (post-) each of four 6-minute walk tests |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 8, 2025 | Jul 25, 2025 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017563 | Lung Diseases, Interstitial |
| D005355 | Fibrosis |
Not provided
Not provided