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

ISRCTN	ISRCTN67448752
DOI	https://doi.org/10.1186/ISRCTN67448752
ClinicalTrials.gov (NCT)	NCT00327873
Protocol serial number	N/A
Sponsor	Repatriation General Hospital (Australia)
Funders	National Health and Medical Research Council (Australia), Cancer Council of Tasmania (Australia), Duke Institute for Care at the End of Life (USA), Doris Duke Charitable Foundation (USA)

Submission date: 29/03/2005
Registration date: 10/05/2005
Last edited: 07/10/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Amy Abernethy
Scientific

Southern Adelaide Palliative Services
700 Goodwood Road
Daw Park, South Australia
5041
Australia

Phone	+61 8 8275 1732
Email	amy.abernethy@duke.edu

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	02 Breathe
Study objectives	Oxygen therapy is superior to air in relieving the sensation of breathlessness in palliative care patients with intractable dyspnoea and PaO2 >55 mmHg Null hypothesis: The provision of home oxygen in patients who do not meet the Australian national guidelines for domiciliary oxygen does not improve the subjective sensation of breathlessness.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Refractory dyspnea
Intervention	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 UK. Participants will receive oxygen or medical air delivered at 2 liters per minute via concentrator and nasal cannulae. Participants are expected to use the treatment for more than 15 hours per day for 7 days. Concentrators will be delivered on the morning of Day 0 and retrieved on the morning of Day 7. Concentrator meters monitored by the company will provide evidence of gas delivery. Participants may continue all normal medications and treatments that they are receiving including physical therapy, exercise, change in position, inhaled treatments, and suctioning. Participants can receive new therapies during the study as would normally be prescribed by their treating doctors. Baseline examination will include medical diagnoses, smoking history, previous experience with oxygen, medications, vital signs, pulse oximetry, Karnofsky performance status, physical examination, resting PaO2, resting PaCO2, hemoglobin, and a description of the breathlessness. Participants will complete a study log twice a day for nine days (days -2 to 7) about the sensation of dyspnea using a 0-10 numeric rating scale (NRS) twice a day, sleep disturbance, breathlessness in the past 24 hours on the NRS, percentage relief of dyspnea, drowsiness, nasal irritation, performance status, vital signs, functional impact, and quality of life (QOL). Functional impact will be measured on the 4-point categorical Modified Medical Research Council of Great Britain (MRC) dyspnea scale and the Dyspnea Exertion Scale (DES).
Intervention type	Other
Primary outcome measure(s)	0-10 Numeric rating scale for dyspnoea.
Key secondary outcome measure(s)	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
Completion date	30/06/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	240
Key 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
Key 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 <10.0 g/dl as measured within one month of baseline evaluation 3. PaCO2 >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
Date of first enrolment	01/10/2004
Date of final enrolment	30/06/2007

Locations

Countries of recruitment

United Kingdom
Australia
United States of America

Study participating centre

Southern Adelaide Palliative Services

Daw Park, South Australia
5041
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	04/09/2010		Yes	No