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A double blind randomized study of oxygen versus medical air in oxygen naïve patients with refractory dyspnea and PaO2 >55 mmHg

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN67448752
Enrollment
240
Registered
2005-05-10
Start date
2004-10-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory dyspnea Respiratory Abnormalities of breathing

Interventions

240 participants will be recruited through the palliative care, oncology, pulmonary, cardiology, and general medicine departments at five sites in Australia, two sites in the USA, and two sites in the

Sponsors

Repatriation General Hospital (Australia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adult patients with intractable dyspnea and PaO2 >55 mmHg 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. 2. Dyspnea can be at rest or with minimal exertion, as measured by a score of =3 on the Medical Research Council categorical dyspnea exertion scale 3. On stable medications over the prior week except routine 'as needed' medications 4. Prognosis of at least 1 month in the opinion of the treating physician

Exclusion criteria

Exclusion criteria: 1. Meets international guidelines for long-term oxygen therapy with PaO2 56-59 mmHg i.e. symptomatic pulmonary hypertension with cor pulmonale 2. Hemoglobin 50 mmHg 4. Confusion with Folstein Mini-mental Status Exam (MMSE) <24/30 5. Current oxygen therapy or continuous oxygen therapy in previous week 6. Actively smoking 7. Active respiratory or cardiac event in the previous 7 days, not including upper respiratory tract infections. Illness must be resolved for at least 7 days prior to baseline evaluation, as judged by a doctor involved in the care of the patient. 8. Previous respiratory failure induced by oxygen 9. Unable to give informed consent or complete diary entries

Design outcomes

Primary

MeasureTime frame
0-10 Numeric rating scale for dyspnoea.

Secondary

MeasureTime frame
1. McGill Quality of Life Questionnaire 2. Modified Medical Research Council Dyspnoea Scale 3. Dyspnoea Exertion Scale 4. Descriptors of dyspnoea 5. Verbal descriptor scales for nausea, drowsiness, nasal irritation, anxiety, patient preference 6. Costs of oxygen/air usage during and following participation

Countries

Australia, United Kingdom, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026