Pulmonary and Total Blood Volume in COPD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-80
SponsorCopenhagen University Hospital, Rigshospitalet

About this trial

Background Patients with chronic obstructive lung disease (COPD) suffer from a progressive loss of lung function that leads to poor quality of life, and often invalidity and early death. This is markedly affected by a reduced exercise capacity and dyspnoea, but the underlying mechanisms are unknown. In the present study, we aim to investigate whether this may involve a reduced pulmonary blood volume secondarily to a reduced total blood volume.

Methods Design: Prospective matched comparative study Intervention: None

Outcomes:

The primary outcome is pulmonary blood volume estimated to total blood volume ratio between patients with COPD and healthy controls individually matched for age, sex, and height.

Statistical design:

All statistical analyses will be performed using R statistical software version 4.1.1 (R Project for Statistical Computing) within RStudio statistical software version 1.4.1717 (RStudio), and a two-tailed p\<0.05 will be considered statistically significant. Inspection of normality and variance homogeneity will be done by creating qq-plots and histogram.

Regulatory considerations: This study will be submitted for approval by Regional Ethical Committee.

Perspective: This study will help uncover fundamental aspects of the pathophysiology of COPD.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Inclusion criteria -patients

Men and women

45-80 years

COPD (GOLD stage I to III)

Disqualifiers

Symptoms of ischaemic heart disease

Known heart failure

Previous severe or current COVID-19

Claudication

Trial population

Sjælland, Denmark

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

32 Participants
are grouped into 2 trial groups
Group A: Healthy controls
Group B: Chronic obstructive pulmonary disease (COPD)

Trial outcomes

Primary outcomes

1

Between-group difference in Pulmonary- and total blood volume ratio (PBV/TBV-ratio)

Time frame
day 2

Secondary outcomes

1

pulmonary capillary blood volume/pulmonary blood volume ratio (VC/PBV-ratio)

Time frame
day 2
2

Between-group difference in total blood volume (TBV)

Time frame
day 2
3

Between-group difference in Pulmonary blood volume (PBV)

Time frame
day 2
4

Between-group difference in total red blood cell volume

Time frame
day 2

Other outcomes

1

Between-group difference in lung tissue mass (LTM)

Time frame
day 2
2

Between-group difference in diffusion capacity, nitrogen oxide ( DL,NO) (mmol/(min kPa)) during upright rest

Time frame
day 2
3

Between-group difference in diffusion capacity, nitrogen oxide (DL,CO,5s) (mmol/(min kPa)) during upright rest

Time frame
day 2
4

Between-group difference in Pulmonary capillary blood volume (VC) during upright rest

Time frame
day 2

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