Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00327873
Status:
COMPLETED
Last Update Posted:
2009-12-14
First Post:
2006-05-18
Brief Title:
Palliative Oxygen for the Relief of Breathlessness
Sponsor:
National Health and Medical Research Council Australia
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
A Multi-center Randomized Double-blind Controlled Trial of Oxygen Versus Medical Air for the Relief of Breathlessness in Patients With Intractable Dyspnea and PaO255mmHg
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main goal of this study is to establish the effectiveness of palliative oxygen in the context within which it is usually provided--relief of the sensation of breathlessness and improvement in quality of life for people with maximally-treated life-limiting illness
Detailed Description:
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 PaO255mmHg 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 PaO255mmHg
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 oxygenair 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
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 PaO255mmHg 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 PaO255mmHg
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 oxygenair 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None