Near-Infrared Spectroscopy Measurements in Chronic Obstructive Pulmonary Disease

NCT06976762 | Enrolling By Invitation DMC

• 1 other identifier: 20-KAEK-212
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Microcirculatory Status; Spectroscopic Analysis; COPD; Renal Failure

Keywords

microcirculation; spectroscopy; pulmonary disease; renal failure

Outcome Measures

Primary Outcomes (4)

• NIRS value-descent curve

  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.

  two minutes

• NIRS value-ascent curve

  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.

  two minutes

• NIRS value-area under curve

  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.

  three minutes

• NIRS value-baseline

  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.

  three minutes

Secondary Outcomes (1)

• blood gas analysis

  one minute

Study Arms (3)

COPD

Patients with aged between 18 and 80 years, a confirmed diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria, a post-bronchodilator forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of \<0.70, and clinically stable COPD, with no exacerbations or hospital admissions within the preceding four weeks were enrolled in this COPD group.

CKD

Patients with aged between 18 and 80 years, evidence of CKD, 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 were enrolled in CKD group.

Control

Healthy individuals

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Lipcsey et al.7 reported that the mean stO2 in volunteers was 80±7%.1 Based on this finding, assuming a 5% decrease in stO2 with a two-sided type I error of 0.05, and a power of 0.80; a total of 144 patients (each group consisted of 48 subjects) were required to find a significant difference between control, patients with COPD and patients with CRD groups.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Renal Insufficiency; Lung Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Daniel MARTIN, Professor

  Uni of Plymouth, Dept of Periop and ICU, Plymouth, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 7, 2024
• First Posted: May 16, 2025
• Study Start: May 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

TU (1)