Status:
ENROLLING_BY_INVITATION
Near-Infrared Spectroscopy Measurements in Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Tokat Gaziosmanpasa University
Conditions:
Microcirculatory Status
Spectroscopic Analysis
Eligibility:
All Genders
18-80 years
Brief Summary
Participants were selected based on three groups: healthy, chronic obstructive pulmonary disease, and chronic renal disease. NIRS was used to measure tissue oxygenation on the thenar region of the rig...
Detailed Description
This study was a prospective observational analysis involving patients with diagnosed Chronic Obstructive Pulmonary Disease (COPD) and Chronic Kidney Disease (CKD). Participants were recruited from th...
Eligibility Criteria
Inclusion
- To be eligible for the study, patients were required to meet all of the following criteria:
- Age: Patients aged between 18 and 80 years.
- COPD Diagnosis: A confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, including:
- A post-bronchodilator forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of \<0.70.
- Renal Failure: Evidence of CKD, defined as:
- An estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m² (Stages 3-5 CKD) on at least two occasions three months apart, or a history of renal replacement therapy.
- Stable Medical Condition: Clinically stable COPD, with no exacerbations or hospital admissions within the preceding four weeks.
Exclusion
- Patients were excluded from the study if they met any of the following criteria:
- Acute Exacerbation: Evidence of an acute COPD exacerbation within four weeks prior to enrolment.
- Other Respiratory Disorders: Coexistence of other chronic respiratory diseases such as asthma, interstitial lung disease, or bronchiectasis that might interfere with the assessment of COPD.
- Renal Transplantation: History of kidney transplantation, as immunosuppressive therapy may affect disease progression and outcomes.
- Uncontrolled Comorbidities: Presence of any uncontrolled comorbid conditions, including:
- Cardiovascular instability or recent myocardial infarction (within six months).
- Active malignancy (other than localized skin cancer).
- Severe liver disease (e.g., cirrhosis with hepatic failure).
- Pregnancy or Breastfeeding: Women who were pregnant or breastfeeding at the time of study enrolment.
- Cognitive Impairment: Any condition that would impair the ability to provide informed consent or participate in study procedures, such as dementia or significant psychiatric disorders.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06976762
Start Date
May 1 2025
End Date
May 30 2025
Last Update
May 16 2025
Active Locations (1)
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1
Tokat Gaziosmanpasa University
Tokat Province, Turkey (Türkiye), 60100