The long term oxygen therapy dosing under stress trial - 6 Minute Walking Test vs. Stress Pulse Oximetry
Recruiting
- Conditions
- J96.1Chronic respiratory failure
- Registration Number
- DRKS00032079
- Lead Sponsor
- ResMed Germany Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Patients with hypoxemia/stress hypoxemia with indication for LTOT according to current guidelines of the German Respiratory Society (DGP)
Exclusion Criteria
• Pneumothorax
• Myocardial infarction in the last month
• unstable angina pectoris
• heart rate at rest > 130/min
• blood pressure at rest > 180/100mmHg
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A combined endpoint of patients presenting either with severe hypoxemia and/or hyperoxigenation after completed O2 titration (pO2 =60mmHg or SpO2 >90%) during 6 MWT or SPO
- Secondary Outcome Measures
Name Time Method • Stress hypoxemia prior to oxygen titration measured by blood gas analysis (BGA) and pulse oximetry at the specification<br>a. to walk a maximum walking distance within 6 minutes<br>b. to walk a distance at normal and accustomed walking speed with a self-selected walking duration (max. 6 minutes)<br>• After completed O2 titration (pO2 =60mmHg or SpO2 >90%) by means of<br>a. SPO, how many patients present with hypoxemia during 6 MWT (SpO2 <80%)<br>b. 6 MWT, how many patients present with hyperoxemia when performing a SPO (SpO2 >93% )<br>• Time required for the 6 MWT and the SPO for guideline-compliant LTOT titration during exercise (target: pO2 =60mmHg or SpO2 90-92%)<br>• Symptoms (dyspnea, feeling of exhaustion) of patients with standardized implementation of a 6 MWTs vs. SPO measured by Borg´s CR-10 scale