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A Multi-center Randomized Double-blind Controlled Trial of Oxygen Versus Medical Air for the Relief of Breathlessness in Patients With Intractable Dyspnea and PaO2>55mmHg

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Trial Information

A Multi-center Randomized Double-blind Controlled Trial of Oxygen Versus Medical Air for the Relief of Breathlessness in Patients With Intractable Dyspnea and PaO2>55mmHg

When further medical management will not relieve intractable breathlessness, palliative
oxygen is often prescribed regardless of whether the person meets the common oxygen funding
criteria of severely low blood oxygen levels. The results of this study will inform best
practice in the care of people with advanced life-limiting illness and intractable
breathlessness, aid in the development of rational funding guidelines, and answer an
international debate on the role of palliative oxygen.

This study is a definitive international multi-center randomized double-blind controlled
trial of oxygen versus medical air for the relief of breathlessness in participants with
intractable dyspnea and PaO2>55mmHg (a measure of blood oxygen levels). Specific aims
include demonstration of the effectiveness of oxygen versus medical air in relieving
breathlessness in the palliative setting (Specific Aim 1) and improving QOL (Specific Aim
2). Additionally, we will seek to establish which patients derive the greatest benefit
(Specific Aim 3), the risks of therapy (Specific Aim 4), and the costs of therapy (Specific
Aim 5). The primary hypothesis is that oxygen therapy is superior to air in relieving the
sensation of breathlessness for patients with intractable dyspnea due to life-limiting
illness in the setting of PaO2>55mmHg.

All participants are enrolled as outpatients. The "eligibility visit" occurs about 5-7 days
before starting the study and will include review of the consent form, a short interview,
physical exam, and blood tests. The visit can occur in the home or clinic. The blood tests
include regular venipuncture and also an arterial blood gas, if these studies have not been
done in the preceding month. The "randomization visit" occurs 2 days before the study
starts (Day -2) and includes a short interview and quality of life (QOL) questionnaire; this
visit is usually done in the home but can also occur in the clinic. The oxygen or air
concentrators are delivered to the home on Day 0 by a trained person from the oxygen
company. On the same day there is also a brief home visit from the study nurse that includes
a short interview and QOL questionnaire. The participant uses the oxygen or medical air gas
each of 7 days (Days 0-6) for at least 15 hours each day. While using the oxygen/air the
participant fills out a short diary form in the morning and evening, within 30 minutes of
waking up or retiring. The diary focuses on the breathlessness, how the participant is
feeling, and potential side effects of the gas. The study nurse conducts a "check-in"
telephone call on Day 3 to make sure the participant is doing OK. On the last day (Day 6)
the nurse visits the home to conduct a brief interview with a short QOL questionnaire. The
oxygen company will pick up the concentrator, usually on Day 7.

Inclusion Criteria:

- Adult patients with intractable dyspnea and PaO2>55mmHg in the setting of terminal
illness where the underlying cause has been maximally treated; a medical specialist
must document that all identified reversible causes of the dyspnea have been treated;
PaO2 measurement must be in the last month

- Dyspnea at rest or with minimal exertion, as measured by a score of ≥ 3 on the
Medical Research Council categorical dyspnea exertion scale

- On stable medications over the prior week except routine "as needed" medications.

- Survival of at least 1 month in the opinion of the treating physician

Exclusion Criteria:

- Meets international guidelines for long-term oxygen therapy with PaO2 56-59mmHg, i.e.
symptomatic pulmonary hypertension with cor pulmonale

- Hemoglobin<10.0g/dL as measured within one month of baseline evaluation

- PaCO2 >50 mm Hg.

- Confusion as measured by Folstein Mini-mental Status Exam <24/30

- Current oxygen therapy or continuous oxygen therapy in previous week

- Actively smoking

- Active respiratory or cardiac event in the previous 2 weeks, not including upper
respiratory tract infections; illness must be resolved for at least 2 weeks prior to
baseline evaluation, as judged by a doctor involved in the care of the patient

- Previous respiratory failure induced by oxygen

- Unable to give informed consent or complete diary entries

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Changes in relief from the sensation of breathlessness

Outcome Time Frame:

7 days

Safety Issue:


Principal Investigator

Amy Abernethy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University


United States: Federal Government

Study ID:




Start Date:

May 2005

Completion Date:

March 2008

Related Keywords:

  • Dyspnea
  • breathlessness
  • shortness of breath
  • end-of-life care
  • hospice
  • Dyspnea



Duke University Department of Medicine, Division of Medical Oncology Durham, North Carolina  27710