Portable Oxygen:

Comparative Results and Patient Preferences

Presented January 2012

Buffalo, NY

DRAFT

Patient Verification of the Focus Advantage

• Focus, at just 1.75 lbs (0.8 kg), the world’s lightest portable oxygen concentrator (POC), combines proven FreeStyle and pulse flow technologies (sensitivity and speed) for effective and efficient oxygen delivery.

• LTOT patients are highly symptomatic: oxygen is used to relieve and reduce symptoms of breathlessness.

• Patients’ number one complaint is the weight of their portable oxygen systems: the heavier the system, the greater the physiologic burden.1

• The weight of the Focus POC improves compliance, independence, and quality of life (QOL).

1 Ambulatory oxygen therapy and compliance: How less is often more. AirSep, 2011. Respiratory Therapy, 6(4), 34-37.

Oxygen Patient Evaluations

• Over a period of 6 months, 40 oxygen patients volunteered to participate in an evaluation comparing Focus to their current portable oxygen system as well as to share their preferences and oxygen usage patterns.

• Patients were requested to walk at their normal pace with their current portable oxygen system and with the new AirSep Focus POC.

• Focus was considered to be equivalent if the participant felt it relieved symptoms and if pulse oximetry results demonstrated saturation levels similar to the current oxygen system.

 

Components of Patient Evaluation

• Ambulatory oxygen patients were recruited from home care companies, newspaper and on-line advertising.

• A local medical facility with a 72 ft. (21.9 m) corridor to walk was selected as the study site.

• Participants walked first with their current portable oxygen and then with Focus.

• Rest periods were provided before and after each walk.

• Pulse oximetry was recorded throughout the evaluation period.

• Participants completed two questionnaires: one after each walk.

Standards Employed

• Participants signed a consent form.

• Referenced and incorporated six-minute walk test (6MWT) standard of no "coaching" of patients.

• In contrast to 6MWT, participants were instructed to walk at their normal pace and to stop when they were tired (usually after 2-3 minutes).

• Standardized log sheet utilized to uniformly record patient statistics and observer comments.

• Used pulse oximeter with finger probe and OxiScan II software to generate an oximetry report for each participant, recording baseline, walk, and rest segments for each system, for a total of six segments per report.

1. Participants needed to bring in and walk with their current portable systems.

2. Settings were up to a 4 pulse setting, or up to 3 LPM for continuous flow (CF).

• 40 patients volunteered to participate in the Focus evaluation.

• 7 patients did not meet eligibility criteria and were excluded from the evaluation, leaving a total of 33 participants.

• 4 patients were excluded for not bringing in their own portable oxygen system.

• 3 patients were excluded for using higher oxygen flows: 2 were on a 5 setting and 1 was on 4 LPM continuous flow.

Eligibility Criteria

• 40 volunteers (25 women and 15 men, mean age 71.3 years, mean BMI 30.4) were recruitedfor participation. Ages ranged from 36-88.

• 7 did not meet eligibility criteria and wereexcluded from participation (2 women and 5 men, mean age 77, mean BMI 27.7). Ages of those excluded ranged from 66-86.

• 33 were included in the evaluation (23 women and 10 men, mean age 70, median age 73, mean BMI 30.9). Participants included were ages 36-88.

• Participants had been on LTOT for durations ranging from 6 months to more than 10 years.

Participants’ Demographics

Participants’ Current Oxygen Systems

• Chad Bonsai (4)

• DeVilbiss PD 1000 (2)

• Caire Helios Plus (2)

• Caire Helios Marathon (2)

• Invacare HomeFill (5)

• PB CR-50 (1)

• Precision EasyPulse 5 (8)

• Respironics ePOD (1)

• Salter O2 Express (3)

• Continuous Flow (CF) 5

Focus provided equivalent oxygen saturations for 30 of the 33 participants (91%), including many on higher oxygen settings.

Of the 17 participants on a 2 setting, all tested equivalent, including 4 on continuous flow (CF).

Participants used the following settings:

• 17 were on a 2 setting (all were equivalent, 4 were on CF)• 3 were on a 2.5 setting (2 were not equivalent)• 8 were on a 3 setting (1 was not equivalent)• 5 were on a 4 setting (all were equivalent)

All 3 participants whose results were not equivalent were using a higher oxygen setting.

Equivalent Saturations and Symptom Relief

Equivalent to Higher Settings

Focus provided equivalent saturations for 13 of the 16 participants (81%) who were on a higher setting than 2. For the 3 that were not equivalent, 2 were on 2.5, and one was on a 3 setting. All 5 participants on a 4 setting, and 7 of the 8 on a 3 setting, did well with Focus.

The 2.5 setting:• The equivalent results came from a participant on continuous flow using a regulator with a D size cylinder. • The other 2 (nonequivalent) results were obtained from participants using a CR-50 and a Caire Helios unit.

The 3 setting:• The 7 equivalent results came from participants using Caire Helios Plus, Invacare HomeFill (2), and Precision EasyPulse (4).• The nonequivalent result was obtained from a participant using a Chad Bonsai.

The 4 setting: • The 5 equivalent results came from participants using Caire Helios Plus, Caire Helios Marathon, Invacare HomeFill, Precision EasyPulse, and a Salter O2 Express.

Why Did Focus Provide the Same Saturations as Higher Settings?

• Even though a patient is on a higher setting, the device may not deliver oxygen as efficiently and effectively as our OCD technology.

• During the evaluation, we observed some of the devices not triggering and missing breaths, especially when LTOT patients are talking or mouth breathing, as many do during exertion. (Some devices create a very loud pulse sound, so we were able to “hear” the missed breaths.)

• Lighter system weight reduces physiological burden.

• Increasing FiO2 does not always increase saturations for certain patients.

Exercise Capacity

• Focus was tested second by each participant, a factor which would be expected to depress the results due to the deconditioned status of LTOT patients.

• In addition to severe COPD, these were elderly, obese participants. – Median age was 73– Average BMI of 30.9 (through self-reported height and weight),

meeting the criteria for obesity.

• However, many participants stated that they felt better on Focus than on their current portable oxygen system, that the oxygen was “fresher,” and that they were getting more “air.” Several participants felt they recovered (caught their breath) quicker when on Focus after the walk, as compared to their system.

Salter O2 Express, 4 Setting – Participant #8

Invacare HomeFill, 2 Setting – Participant #26

Invacare HomeFill, 2 Setting – Participant #28

Is 90% Saturation Realistic? • 2/3 of participants (22 out of 33) desaturated

below 90% while walking at their normal pace.

• Some desaturated into the low to mid 80s; some even dropped into the low to mid 70s.

• It may not be reasonable to expect saturations ≥90% during activity for the majority of these patients.

• Walking several minutes for LTOT patients causes symptoms and necessitates stopping to rest. Portable oxygen reduces and reverses symptoms, and patients have a good sense of what provides relief for them.

67% desaturated

Motivation for Oxygen Use• COPD patients on LTOT have end-stage pulmonary disease with a high

occurrence of cardiac disease. While COPD is not curable, oxygen therapy relieves symptoms, improves quality of life, and increases life expectancy in patients with severe resting hypoxemia.2

• End-stage COPD patients become very symptomatic and experience dyspnea (shortness of breath). They become motivated to use oxygen to relieve and reduce symptoms.

• COPD patients are extremely motivated to find the lightest portable oxygen system that helps relieve their symptoms, and they know what works for them.

• 90% of COPD oxygen patients were, or still are, smokers, which may lead to embarrassment about using oxygen in public, particularly cylinders, which are recognizable. This can delay the use of portable oxygen until symptoms become severe. If they do not perceive a benefit, they will not use portable oxygen. This is very analogous to CPAP therapy.

2 Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org/

AmbulationLTOT is indicated for patients with chronic respiratory failure and a resting PaO2

≤55mmHg or a Sat ≤88%. These patients would be classified as GOLD 4 (very severe airflow limitation), correlating with mMRC (modified Medical Research Council ) questionnaire Grade 4 (I am too breathless to leave the house or I am breathless when dressing or undressing).3

This point was evidenced by participants becoming breathless when merely adjusting the POC belts/straps.

Realistic ambulation goals for LTOT patients include:• Maintaining independence • Preserving social lives• Ability to run errands • Safely getting from one location to another without the need for caregivers to carry or transport their portable oxygen systems.

3 Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for

Chronic Obstructive Lung Disease (GOLD) 2011. Available from: http://www.goldcopd.org/

Patient Preference

• Many factors affect patient satisfaction and compliance with their portable oxygen systems in addition to oxygen saturation and symptom relief. Compliance is significantly influenced by a patient’s ability to carry or transport the weight of a system.

• Regardless of the portable oxygen system, saturation will be lower if patients are unwilling or unable to use their oxygen for ambulation due to its weight.

• Patients unable to carry or transport their oxygen independently will need to rely on a caregiver.

Patient Preference (Cont’d)

• The physiologic burden of carrying portable oxygen may be different if the weight is supported on the shoulder(s) versus the waist, and varies according to individual patient preferences and comorbid conditions.

• Portable systems on carts become burdensome when navigating curbs or steps, and need to be lifted when being placed in a vehicle.

• Patients have reported making the decision to use their oxygen based on the availability of a shopping cart at a store or market.

Questionnaire Results

• 74% of participants strongly agreed (42%) or agreed (32%) with the statement that their current oxygen system limits their activities.

• 71% of participants reported times when they do not use their current portable oxygen system when they should.

• 71% of participants strongly agreed, or agreed (29%), that the Focus POC is not too heavy, and 97% believed it would allow them to participate in more activities than their current system.

• 80% of participants strongly agreed (48%) or agreed (32%) with the

statement that their current portable oxygen system is too heavy.

The Focus Preference!

90% of participants reported that they would prefer to use Focus instead of their current oxygen system.

• A lighter portable oxygen system is easier for patients to transport and carry, preserving independence and promoting ambulation.

• This translates into increased patient satisfaction, compliance, and oxygen saturations.