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NCT Number: NCT06976762

Near-Infrared Spectroscopy Measurements in Chronic Obstructive Pulmonary Disease

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 right hand. A pressure cuff was used to temporarily occlude arterial inflow, thus allowing the response to this to be assessed. The StO2 was plotted against time, and the following variables were calculated, the downslope, upslope, area under curve.

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Key information

About this study

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 the pulmonary and nephrology clinics at Gaziosmanpasa University Health Application and Research Centre during their stay in the ward. The study was approved by the Tokat Gaziosmanpasa Research Ethics Committee (Grant number: 20-KAEK-212) and all patients provided informed consent prior to participation.

Data collection involved baseline assessments of demographic characteristics, COPD severity, renal function, and comorbidities. Participants were divided into three groups: control, COPD, and CRD. Patients were visited during their stay in the ward and the measurement was initiated after five minutes of rest. Venous blood gas analysis was performed using the same sample of blood obtained for routine complete blood count analysis. A vascular occlusion test was conducted with NIRS measurements taken throughout. Three minutes of baseline measurement placing the probe on thenar eminence of the right hand was completed while the patient was lying with 45 degrees back up position. After baseline measurements a non-invasive blood pressure cuff was placed on the right arm and it was inflated to 250 mmHg. The cuff was held inflated for two minutes; after two minutes, the cuff was deflated and the measurement had been continued for another three minutes and stopped. Near-infrared spectroscopy measurements were obtained during and after vascular occlusion, including the area under curve (AUC) during occlusion (representing tissue hyperemia) and the angles of descent and ascent, which reflect muscle oxygen consumption and microcirculatory function, respectively.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. NIRS value-descent curve

    Time frame: two minutes

    After baseline measurements a non-invasive blood pressure cuff was placed on the right arm and it was inflated to 250 mmHg. The cuff was held inflated for two minutes; after two minutes, the cuff was deflated and the measurement had been continued for another three minutes and stopped. Near-infrared spectroscopy measurements were obtained during and after vascular occlusion, including the area under curve (AUC) during occlusion (representing tissue hyperemia) and the angles of descent and ascent, which reflect muscle oxygen consumption and microcirculatory function, respectively.

  2. NIRS value-ascent curve

    Time frame: two minutes

    After baseline measurements a non-invasive blood pressure cuff was placed on the right arm and it was inflated to 250 mmHg. The cuff was held inflated for two minutes; after two minutes, the cuff was deflated and the measurement had been continued for another three minutes and stopped. Near-infrared spectroscopy measurements were obtained during and after vascular occlusion, including the area under curve (AUC) during occlusion (representing tissue hyperemia) and the angles of descent and ascent, which reflect muscle oxygen consumption and microcirculatory function, respectively.

  3. NIRS value-area under curve

    Time frame: three minutes

    After baseline measurements a non-invasive blood pressure cuff was placed on the right arm and it was inflated to 250 mmHg. The cuff was held inflated for two minutes; after two minutes, the cuff was deflated and the measurement had been continued for another three minutes and stopped. Near-infrared spectroscopy measurements were obtained during and after vascular occlusion, including the area under curve (AUC) during occlusion (representing tissue hyperemia) and the angles of descent and ascent, which reflect muscle oxygen consumption and microcirculatory function, respectively.

  4. NIRS value-baseline

    Time frame: three minutes

    After baseline measurements a non-invasive blood pressure cuff was placed on the right arm and it was inflated to 250 mmHg. The cuff was held inflated for two minutes; after two minutes, the cuff was deflated and the measurement had been continued for another three minutes and stopped. Near-infrared spectroscopy measurements were obtained during and after vascular occlusion, including the area under curve (AUC) during occlusion (representing tissue hyperemia) and the angles of descent and ascent, which reflect muscle oxygen consumption and microcirculatory function, respectively.

Secondary outcomes

  1. blood gas analysis

    Time frame: one minute

    Venous blood gas analysis was performed using the same sample of blood obtained for routine complete blood count analysis.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

Near-Infrared Spectroscopy Measurements in Patients With Chronic Obstructive Pulmonary Disease, and Chronic Renal Disease: An Observational Study

Acronym: NIRS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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