Microcirculatory StatusNIRSNCT06976762
Near-Infrared Spectroscopy Measurements in Chronic Obstructive Pulmonary Disease
An observational study of Microcirculatory Status and Spectroscopic Analysis, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Microcirculatory Status, Spectroscopic Analysis, COPD
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 30 May 2025
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Tokat Gaziosmanpasa University
Tokat Province, 60100
About this study
Official title: Near-Infrared Spectroscopy Measurements in Patients With Chronic Obstructive Pulmonary Disease, and Chronic Renal Disease: An Observational Study
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.
Read the 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 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.
- Conditions
- Microcirculatory Status, Spectroscopic Analysis, COPD, Renal Failure
- Keywords
- microcirculation, spectroscopy, pulmonary disease, renal failure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Renal Insufficiency, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: three minutes
Secondary outcomes (1)
blood gas analysis
Venous blood gas analysis was performed using the same sample of blood obtained for routine complete blood count analysis.
Measured: one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 May 2025
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microcirculatory StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Dogru, Tokat Gaziosmanpasa University
- Investigators
- Daniel MARTIN, Professor, Principal investigator, Uni of Plymouth, Dept of Periop and ICU, Plymouth, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976762
- Sponsor's protocol ID
- 20-KAEK-212
- Acronym
- NIRS
- Status last verified
- May 2025
- First submitted
- 7 Dec 2024
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It can be illegal to share the personal information of the individuals recruited in the study.
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-Infrared Spectroscopy Measurements in Patients With Chronic Obstructive Pulmonary Disease, and Chronic Renal Disease: An Observational Study
- ClinicalTrials.gov ID
- NCT06976762
- Acronym / sponsor ID
- NIRS / 20-KAEK-212
- Conditions
- Microcirculatory Status, Spectroscopic Analysis, COPD, Renal Failure
- Keywords
- microcirculation, spectroscopy, pulmonary disease, renal failure
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- To be eligible for the study, patients were required to meet all of the following criteria:
Key exclusion criteria (10 listed)
- Patients were excluded from the study if they met any of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
1 secondary outcome
blood gas analysis
Time frame: one minute
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Individual participant dataSharing planned: Undecided. It can be illegal to share the personal information of the individuals recruited in the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel MARTIN, Professor principal investigator
Uni of Plymouth, Dept of Periop and ICU, Plymouth, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcirculatory Status and Spectroscopic Analysis, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIRS value-descent curve (time frame: two minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.