Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545851
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-08-08
Brief Title:
Effects of an Automatic Oxygen Titration System in People With Hypoxemia During Exercise Training
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Automatic Oxygen Titration Versus Constant Oxygen Flow Rates During Exercise Training in Hypoxemic People With Chronic Lung Disease - a Randomized Double-blind Controlled Cross-over Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Long-term oxygen therapy is a fundamental treatment modality for patients with chronic hypoxaemic lung disease Typically oxygen is administered at a constant flow rate However due to fluctuating activity levels patients oxygenation status can vary potentially leading to oxygen desaturation and increased dyspnoea
Emerging evidence suggests that automatic oxygen titration - a method of adjusting oxygen flow in response to current oxygen saturation - may have acute advantages over constant oxygen flow
The primary objective of this study is to investigate the effect of automatic oxygen titration compared to prescribed constant oxygen flow rates on patients perceived dyspnoea during exercise endurance training
Emerging evidence suggests that automatic oxygen titration - a method of adjusting oxygen flow in response to current oxygen saturation - may have acute advantages over constant oxygen flow
The primary objective of this study is to investigate the effect of automatic oxygen titration compared to prescribed constant oxygen flow rates on patients perceived dyspnoea during exercise endurance training
Detailed Description:
Rationale
Hypoxaemia is common in people with chronic lung disease and can affect exercise tolerance Oxygen therapy is then recommended
Oxygen supplementation is usually delivered at constant oxygen flow rates Only a few studies have investigated the short-term effects of automated oxygen delivery compared to a constant oxygen flow rate during exercise tests eg 6-minute walk test shuttle walk tests These studies have shown that automatic oxygen delivery can lead to an acute increase in exercise capacity including an improvement in the perception of breathlessness The use of automated oxygen delivery during endurance exercise has not been studied The most common reason for stopping prolonged exercise in patients with chronic lung disease is dyspnoea Therefore the use of automatic oxygen delivery in a pulmonary rehabilitation clinic could be beneficial in the context of personalised therapy for patients requiring oxygen if it further reduces dyspnoea potentially enabling the patient to train their endurance even better
Therefore the primary aim of this study was to investigate whether the use of automatic oxygen supplementation versus constant oxygen supplementation has a different effect on the perception of dyspnoea in patients with hypoxaemia during endurance exercise
Design
This study is designed as a randomised double-blind controlled cross-over trial Participants will first undergo a cycle-based peak work rate test to determine their individual maximal peak work rate They then take part in two sets of five endurance training sessions One set is performed with a constant oxygen flow prescribed for each participant while the other uses automatic oxygen titration The order in which these two sessions are performed is randomised
Hypoxaemia is common in people with chronic lung disease and can affect exercise tolerance Oxygen therapy is then recommended
Oxygen supplementation is usually delivered at constant oxygen flow rates Only a few studies have investigated the short-term effects of automated oxygen delivery compared to a constant oxygen flow rate during exercise tests eg 6-minute walk test shuttle walk tests These studies have shown that automatic oxygen delivery can lead to an acute increase in exercise capacity including an improvement in the perception of breathlessness The use of automated oxygen delivery during endurance exercise has not been studied The most common reason for stopping prolonged exercise in patients with chronic lung disease is dyspnoea Therefore the use of automatic oxygen delivery in a pulmonary rehabilitation clinic could be beneficial in the context of personalised therapy for patients requiring oxygen if it further reduces dyspnoea potentially enabling the patient to train their endurance even better
Therefore the primary aim of this study was to investigate whether the use of automatic oxygen supplementation versus constant oxygen supplementation has a different effect on the perception of dyspnoea in patients with hypoxaemia during endurance exercise
Design
This study is designed as a randomised double-blind controlled cross-over trial Participants will first undergo a cycle-based peak work rate test to determine their individual maximal peak work rate They then take part in two sets of five endurance training sessions One set is performed with a constant oxygen flow prescribed for each participant while the other uses automatic oxygen titration The order in which these two sessions are performed is randomised
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