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 number | NCT00327873 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Southern Adelaide Palliative Services
700 Goodwood Road
Daw Park, South Australia
5041
Australia
| Phone | +61 8 8275 1732 |
|---|---|
| amy.abernethy@duke.edu |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 0-10 Numeric rating scale for dyspnoea. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/10/2004 |
| Completion date | 30/06/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
- Australia
- United Kingdom
- United States of America
Study participating centre
Southern Adelaide Palliative Services
Daw Park, South Australia
5041
Australia
5041
Australia
Sponsor information
Repatriation General Hospital (Australia)
Hospital/treatment centre
Hospital/treatment centre
Daws Road
Daw Park
South Australia
5041
Australia
"ROR" |
https://ror.org/04b0n4406 |
|---|
Funders
Funder type
Research organisation
National Health and Medical Research Council (Australia)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Cancer Council of Tasmania (Australia)
No information available
Duke Institute for Care at the End of Life (USA)
No information available
Doris Duke Charitable Foundation (USA)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Doris Duke Charitable Foundation, Inc., DDCF Trust, Doris Duke Foundation, DDCF
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 04/09/2010 | Yes | No |
