Chronic Obstructive Pulmonary DiseaseNCT02329522
USCOM For Assessing Patients With COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Objective The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this study are: 1. To investigate whether there is any correlation between haemodynamic parameters and COPD severity. 2. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Ultrasonic Cardiac Output Monitor and Spirometry
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with a de novo diagnosis of COPD or a known history of COPD who attend a respiratory clinic or the emergency department in the Prince of Wales Hospital (Shatin, Hong Kong) will be recruited.
Who may be able to join
- Age >40 years;
- Clinically diagnosed as COPD by physicians;
- Obtain any one of exacerbating symptoms (increased dyspnoea, sputum production, sputum volume, wheeze, cough or exertional dyspnoea);
Who cannot join
- Known or suspected pregnancy, lactating patients, active malignancies, severe mobility problems (e.g. significant painful arthritis), and confusion or dementia .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Invasive Doppler Ultrasound For Assessing Patients With Chronic Obstructive Pulmonary Disease: A Prospective Observational Study
Objective
The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this study are:
Read more
- To investigate whether there is any correlation between haemodynamic parameters and COPD severity.
- To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 6-month, 1-year, 3-year and 5-year readmission.
- To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 6-month, 1-year, 3-year and 5-year all-cause mortality.
Design, Setting and Subjects This prospective observational study will be conducted in the Prince of Wales Hospital in Hong Kong.
Interventions Haemodynamic measurements made using the USCOM, and spirometry, will be performed as appropriate on subjects in respiratory clinic, the emergency department, medical wards and on ICU. In order to assess inter-observer variability, a second, blinded operator will repeated 15% of scans.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the world, a lung disorder which is characterized by a partially reversible airflow limitation, which is usually progressive, and associated with an abnormal inflammatory response to noxious particles or gases. In 2005, among elderly Hong Kong Chinese (age ≥60 years) in Hong Kong with COPD defined as an FEV1/FVC <70%, 19.6% males and 11.9% females suffered from moderate levels of severity.
From an initial stable condition, an acute exacerbation of COPD (AECOPD) is characterized by a sudden onset of breathlessness, purulent sputum, and increases in sputum volume. Other symptoms include increasing cough, wheeze, chest tightness or fatigue. The major cause of AECOPD is infection, although other stimulating factors include air pollution, withdrawal of medication, and low temperature. After the first admission of an exacerbation, the readmission rate for patients with AECOPD is high. The mean number of annual readmissions is 2.2 episodes, with a one-year mortality rate of 14%.
Spirometry can help to diagnose COPD patients, and a post-bronchodilator FEV1/FVC<0.7 confirms the presence of airflow limitation. The classification of severity of airflow limitation in COPD is based on GOLD category. The lower the post-bronchodilator FEV1, the higher is the severity. This method is useful for assessing patients with stable COPD only. For those with AECOPD, this method may not be easy to conduct and assess patients immediately due to patients' difficulty in breathing.
A common dilemma facing clinicians is whether patients presenting with breathlessness, cough and wheeze have an acute exacerbation of COPD, an acute exacerbation of left ventricular failure (LVF), or some degree of both. Making an accurate diagnosis is important as the treatment in each case is different, and a quick recovery depends upon appropriate and timely intervention and treatment.
Unlike acute exacerbations of asthma, there are no objective guidelines on how to assess the severity and prognosis of patients presenting to hospital with acute exacerbations of COPD. However, the CURB65, originally intended for assessing patients with pneumonia, has been evaluated in this context. High CURB65 scores in patients presenting with acute exacerbations of COPD do predict increasing risk of hospital and one month mortality from 2 to 21% but do not predict patients with very high risk.
In healthy subjects, the presence or absence of carbon dioxide retention influences the body's haemodynamic response. Hypercapnia has been shown to increase mean pulmonary artery pressure (PAP), pulmonary vascular resistance (PVR), heart rate (HR), stroke volume (SV), cardiac output (CO), and mean arterial BP (MAP). However, hypercapnia does not appear to affect indices of systolic function, such as peak aortic velocity and aortic mean and peak acceleration, or plasma renin, angiotensin II, and aldosterone activity.
In stable patients with compensated COPD, elevations in CO2 trigger central and peripheral chemoreceptors resulting in an increased depth and rate of respiration, bradycardia (via vagal stimulation), and systemic vasoconstriction (via sympathetic stimulation). Therefore, cardiovascular parameters may be either normal or, if there is a degree of carbon dioxide retention resulting in catecholamine release and autonomic stimulation, then moderately hyperdynamic. Patients with COPD should have a cardiac Index (CI), which is elevated either towards the upper half or above the normal range, and may be as high as 5L/min/m2, an elevated SI, an elevated SVR and elevated DO2.
The Smith-Madigan Index II (SMII) is a novel measure of inotropy, which in stable COPD patients should either be normal or, if there are adrenergic effects, then may be elevated to as much as 1.6. The effects of hypercapnia in patients with COPD on potential to kinetic energy ratio (PE/KE, PKR), flow time (FT), peak velocity (Vpk) and mean pressure gradient (Pmn) are unknown.
These changes contrast with patients with acute LVF, where CI is low and the SMII is usually less than 1.0, and commonly around 0.7 - 0.8. PE/KE and SVR are generally much higher, and FT (as a function of SV) is longer. Vpk and Pmn are also lower in LVF.
We have conducted a preliminary study to evaluate the correlation between severity of COPD and haemodynamic parameters. 86 stable COPD patients, 43 AECOPD patients and 36 healthy, age and gender matched subjects were recruited. It was found that the severity of COPD correlated positively with mean heart rate, cardiac index (CI), ejection time percentage (ET%) oxygen delivery index (DO2I) and inotropy. When compared with healthy controls, stable GOLD IV patients had a significantly higher CI (3.98 vs 3.15 l/min/m2, p<0.005), inotropy (2.14 vs 1.72 W/m2, p<0.01) and DO2I (679.8 vs 530.7 ml/min/m2, p<0.01), and a significantly lower potential to kinetic energy ratio (PKR) (43.0 vs 56.6, p<0.05). Moreover, the 30-day readmission rate was the highest in GOPD IV patients. Based on the existing findings, it would be interesting to study the long-term prognostic effect of haemodynamic parameters in COPD patients.
Aim
The aims of the present study for patients visited respiratory clinic or admitted to the Emergency Department (ED), including those admitted to resuscitation room or emergency high dependency unit, are:
- To investigate whether there is any correlation between haemodynamic parameters and COPD severity.
- To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 6-month, 1-year, 3-year and 5-year readmission.
- To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 6-month, 1-year, 3-year and 5-year all-cause mortality.
Measurements
- Haemodynamic measurements using an Ultrasonic Cardiac Output Monitor (USCOM®; USCOM Pty Ltd, NSW, Australia)
- Lung function assessment using Spirometry (MICROLAB 3300 spirometer; Micro Medical, Kent, UK)
- 6-minute walk test
- Borg dyspnoea scale
- Blood pressure
- End-tidal CO2
Definition of haemodynamic parameters:
- Velocity time integral (vti) is the integral of the flow profile, i.e. the distance the blood travels in one beat. The unit of vti is m/s.
- Cardiac output (CO) is the volume of blood pumped by the heart in one minute: CO = SV x HR. The unit is l/min.
- Cardiac index (CI) is equal to CO divided by BSA. The unit is l/min/m2.
- Stroke volume (SV) is the volume of blood ejected from the heart during one systolic stroke. SV = vti x πr2,where πr2 = flow cross sectional area. The unit of SV is ml.
- Stroke volume index (SVI) is SV divided by BSA and the unit is ml/m2.
- Stroke volume variation (SVV) is the percentage change in SV between a group of beats. SVV = (SVmax - SVmin x 100) / [(SVmax + SVmin)/2].
- Systemic vascular resistance (SVR) is the pressure against which the heart pumps. SVR = MAP/CO. The unit is d.s.cm-5.
- Systemic vascular resistance index (SVRI) SVRI = SVR x BSA d.s.cm-5m2.
- Oxygen delivery (DO2) is calculated by the equation: DO2 = 1.34 x Hb x SpO2/100 x CO, where Hb = hemoglobin in grams of hemoglobin per litre of blood (g/l); SpO2 = the peripheral oxygen saturation as a percentage (%). The unit of DO2 is ml/min.
- Oxygen delivery index (DO2I) is equal to DO2 divided by BSA. The unit of DO2I is ml/min/m2.
- Inotropy index refers to (Potential energy + Kinetic energy) divided by body surface area. The unit of inotropy is W/m2.
- Potential to kinetic energy ratio (PKR) is the energy used to produce blood pressure divided by the energy used to produce blood flow.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Ultrasonic Cardiac Output Monitor, Spirometry
- Keywords
- Haemodynamics, Chronic obstructive pulmonary disease, Ultrasonic Cardiac Output Monitor, severity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Cardiac Output MonitorDevice
Also called USCOM
An Ultrasonic Cardiac Output Monitor (USCOM; USCOM Pty Ltd, NSW, Australia) is a non-invasive Doppler ultrasonography. It is capable of measuring haemodynamic parameters non-invasively and appears to be simple and rapid to use, portable, relatively inexpensive and has less potential complications compared with the standard technique, pulmonary artery thermodilution (PATD).
USCOM scans will be performed on patients to measure direct and derived haemodynamic variables, which will be performed in the supine position wherever possible. A transducer will be placed on the chest in either the suprasternal position to measure trans-aortic blood flow, or the left parasternal position to measure transpulmonary blood flow.
SpirometryDevice
Also called Lung function test
Spirometry assesses lung function through measuring the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. Patients are regarded as COPD if their Forced expiratory volume in 1 second (FEV1) to Forced vital capacity (FVC) ratio are smaller than 70%. Patients were required to perform three blowing manoeuvres, and post-bronchodilator test results were obtained within 20 minutes to 4 hours after inhaling 400 mg of salbultamol.
| Study group | Role | What they receive |
|---|---|---|
| Stable COPD patients | Patients will be assessed using USCOM and spirometry. For those with FEV1 to FVC ratio smaller than 70%, they will be classified as COPD. Receives: Device: Ultrasonic Cardiac Output Monitor; Device: Spirometry | |
| AECOPD patients | Patients will be assessed using USCOM and spirometry. Spirometry will be assessed after 2 to 4 weeks post-hospital discharge. Receives: Device: Ultrasonic Cardiac Output Monitor; Device: Spirometry | |
| Patient Controls | Patients will be assessed using USCOM and spirometry. For those with COPD symptoms but FEV1 to FVC ratio greater than 70%, they will be classified as non-COPD. Receives: Device: Ultrasonic Cardiac Output Monitor; Device: Spirometry | |
| Healthy Controls | Healthy subjects, with no history of COPD or other significant chronic illness will be recruited as healthy controls. Subjects will be matched for age and gender with the patient groups. They will be assessed using USCOM. Receives: Device: Ultrasonic Cardiac Output Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in mean cardiac index (CI) among the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage I, II, III, IV and healthy subjects.
Measured: On Day 1
Secondary outcomes (5)
The difference in velocity time interval (vti) obtained using USCOM among GOLD stage I, II, III, IV and healthy subjects
USCOM - Ultrasonic Cardiac Output Monitor Please see the definition of the haemodynamic parameters in Detailed Description.
Measured: On Day 1
The differences in USCOM-derived haemodynamic parameters, including CO, SV, SVI, SVV, SVR, SVRI, DO2, DO2I, Intropy and PKR obtained using USCOM among GOLD stage I, II, III, IV and healthy subjects
Please see the definition of the haemodynamic parameters in Detailed Description.
Abbreviation: cardiac output (CO), stroke volume (SV), stroke volume index (SVI), stroke volume variation (SVV), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), oxygen delivery (DO2), oxygen delivery index (DO2I), Intropy and potential to kinetic energy ratio (PKR)
Measured: On Day 1
The differences in USCOM-derived haemodynamic parameters, including CO, CI, SVR, SVRI, SVV, DO2, DO2I, Intropy and PKR between stable and acute exacerbated condition
Please see the definition of the haemodynamic parameters in Detailed Description.
Abbreviation: cardiac output (CO), cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), stoke volume variation (SVV), oxygen delivery (DO2), oxygen delivery index (DO2I), Intropy and potential to kinetic energy ratio (PKR).
Measured: On Day 1
The number of 6-month, 1-year, 3-year and 5-year readmission in COPD patients
Measured: Year 5
The number of 6-month, 1-year, 3-year and 5-year all-cause mortality in COPD patients
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2014
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy H Rainer, Chinese University of Hong Kong
- Investigators
- Timothy H Rainer, MD FCEM, Principal investigator, Accident & Emergency Medicine Academic Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329522
- Sponsor's protocol ID
- 2013.640
- Status last verified
- Sep 2017
- First submitted
- 22 Dec 2014
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Ko FW, Woo J, Tam W, Lai CK, Ngai J, Kwok T, Hui DS. Prevalence and risk factors of airflow obstruction in an elderly Chinese population. Eur Respir J. 2008 Dec;32(6):1472-8. doi: 10.1183/09031936.00058708. Epub 2008 Aug 6.
PubMed 18684847Wedzicha JA. Role of viruses in exacerbations of chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2004;1(2):115-20. doi: 10.1513/pats.2306030.
PubMed 16113423Anderson HR, Spix C, Medina S, Schouten JP, Castellsague J, Rossi G, Zmirou D, Touloumi G, Wojtyniak B, Ponka A, Bacharova L, Schwartz J, Katsouyanni K. Air pollution and daily admissions for chronic obstructive pulmonary disease in 6 European cities: results from the APHEA project. Eur Respir J. 1997 May;10(5):1064-71. doi: 10.1183/09031936.97.10051064.
PubMed 9163648Wouters EF, Postma DS, Fokkens B, Hop WC, Prins J, Kuipers AF, Pasma HR, Hensing CA, Creutzberg EC; COSMIC (COPD and Seretide: a Multi-Center Intervention and Characterization) Study Group. Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial. Thorax. 2005 Jun;60(6):480-7. doi: 10.1136/thx.2004.034280.
PubMed 15923248Donaldson GC, Seemungal T, Jeffries DJ, Wedzicha JA. Effect of temperature on lung function and symptoms in chronic obstructive pulmonary disease. Eur Respir J. 1999 Apr;13(4):844-9. doi: 10.1034/j.1399-3003.1999.13d25.x.
PubMed 10362051Osman IM, Godden DJ, Friend JA, Legge JS, Douglas JG. Quality of life and hospital re-admission in patients with chronic obstructive pulmonary disease. Thorax. 1997 Jan;52(1):67-71. doi: 10.1136/thx.52.1.67.
PubMed 9039248Ko FW, Ng TK, Li TS, Fok JP, Chan MC, Wu AK, Hui DS. Sputum bacteriology in patients with acute exacerbations of COPD in Hong Kong. Respir Med. 2005 Apr;99(4):454-60. doi: 10.1016/j.rmed.2004.09.011.
PubMed 15763452Chang CL, Sullivan GD, Karalus NC, Mills GD, McLachlan JD, Hancox RJ. Predicting early mortality in acute exacerbation of chronic obstructive pulmonary disease using the CURB65 score. Respirology. 2011 Jan;16(1):146-51. doi: 10.1111/j.1440-1843.2010.01866.x.
PubMed 20920140Kiely DG, Cargill RI, Lipworth BJ. Effects of hypercapnia on hemodynamic, inotropic, lusitropic, and electrophysiologic indices in humans. Chest. 1996 May;109(5):1215-21. doi: 10.1378/chest.109.5.1215.
PubMed 8625670Smith BE, Madigan VM. Non-invasive method for rapid bedside estimation of inotropy: theory and preliminary clinical validation. Br J Anaesth. 2013 Oct;111(4):580-8. doi: 10.1093/bja/aet118. Epub 2013 May 3.
PubMed 23645929
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Doppler Ultrasound For Assessing Patients With Chronic Obstructive Pulmonary Disease: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02329522
- Acronym / sponsor ID
- 2013.640
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Haemodynamics, Chronic obstructive pulmonary disease, Ultrasonic Cardiac Output Monitor, severity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Sep 2020 (estimated)
- First posted
- 31 Dec 2014 (estimated)
- 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.
Objective
The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this study are:
- To investigate whether there is any correlation between haemodynamic parameters and COPD severity.
- To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 6-month, 1-year, 3-year and 5-year readmission.
- To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 6-month, 1-year, 3-year and 5-year all-cause mortality.
Design, Setting and Subjects This prospective observational study will be conducted in the Prince of Wales Hospital in Hong Kong.
Interventions Haemodynamic measurements made using the USCOM, and spirometry, will be performed as appropriate on subjects in respiratory clinic, the emergency department, medical wards and on ICU. In order to assess inter-observer variability, a second, blinded operator will repeated 15% of scans.
Detailed description
Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the world, a lung disorder which is characterized by a partially reversible airflow limitation, which is usually progressive, and associated with an abnormal inflammatory response to noxious particles or gases. In 2005, among elderly Hong Kong Chinese (age ≥60 years) in Hong Kong with COPD defined as an FEV1/FVC <70%, 19.6% males and 11.9% females suffered from moderate levels of severity.
From an initial stable condition, an acute exacerbation of COPD (AECOPD) is characterized by a sudden onset of breathlessness, purulent sputum, and increases in sputum volume. Other symptoms include increasing cough, wheeze, chest tightness or fatigue. The major cause of AECOPD is infection, although other stimulating factors include air pollution, withdrawal of medication, and low temperature. After the first admission of an exacerbation, the readmission rate for patients with AECOPD is high. The mean number of annual readmissions is 2.2 episodes, with a one-year mortality rate of 14%.
Spirometry can help to diagnose COPD patients, and a post-bronchodilator FEV1/FVC<0.7 confirms the presence of airflow limitation. The classification of severity of airflow limitation in COPD is based on GOLD category. The lower the post-bronchodilator FEV1, the higher is the severity. This method is useful for assessing patients with stable COPD only. For those with AECOPD, this method may not be easy to conduct and assess patients immediately due to patients' difficulty in breathing.
A common dilemma facing clinicians is whether patients presenting with breathlessness, cough and wheeze have an acute exacerbation of COPD, an acute exacerbation of left ventricular failure (LVF), or some degree of both. Making an accurate diagnosis is important as the treatment in each case is different, and a quick recovery depends upon appropriate and timely intervention and treatment.
Unlike acute exacerbations of asthma, there are no objective guidelines on how to assess the severity and prognosis of patients presenting to hospital with acute exacerbations of COPD. However, the CURB65, originally intended for assessing patients with pneumonia, has been evaluated in this context. High CURB65 scores in patients presenting with acute exacerbations of COPD do predict increasing risk of hospital and one month mortality from 2 to 21% but do not predict patients with very high risk.
In healthy subjects, the presence or absence of carbon dioxide retention influences the body's haemodynamic response. Hypercapnia has been shown to increase mean pulmonary artery pressure (PAP), pulmonary vascular resistance (PVR), heart rate (HR), stroke volume (SV), cardiac output (CO), and mean arterial BP (MAP). However, hypercapnia does not appear to affect indices of systolic function, such as peak aortic velocity and aortic mean and peak acceleration, or plasma renin, angiotensin II, and aldosterone activity.
In stable patients with compensated COPD, elevations in CO2 trigger central and peripheral chemoreceptors resulting in an increased depth and rate of respiration, bradycardia (via vagal stimulation), and systemic vasoconstriction (via sympathetic stimulation). Therefore, cardiovascular parameters may be either normal or, if there is a degree of carbon dioxide retention resulting in catecholamine release and autonomic stimulation, then moderately hyperdynamic. Patients with COPD should have a cardiac Index (CI), which is elevated either towards the upper half or above the normal range, and may be as high as 5L/min/m2, an elevated SI, an elevated SVR and elevated DO2.
The Smith-Madigan Index II (SMII) is a novel measure of inotropy, which in stable COPD patients should either be normal or, if there are adrenergic effects, then may be elevated to as much as 1.6. The effects of hypercapnia in patients with COPD on potential to kinetic energy ratio (PE/KE, PKR), flow time (FT), peak velocity (Vpk) and mean pressure gradient (Pmn) are unknown.
These changes contrast with patients with acute LVF, where CI is low and the SMII is usually less than 1.0, and commonly around 0.7 - 0.8. PE/KE and SVR are generally much higher, and FT (as a function of SV) is longer. Vpk and Pmn are also lower in LVF.
We have conducted a preliminary study to evaluate the correlation between severity of COPD and haemodynamic parameters. 86 stable COPD patients, 43 AECOPD patients and 36 healthy, age and gender matched subjects were recruited. It was found that the severity of COPD correlated positively with mean heart rate, cardiac index (CI), ejection time percentage (ET%) oxygen delivery index (DO2I) and inotropy. When compared with healthy controls, stable GOLD IV patients had a significantly higher CI (3.98 vs 3.15 l/min/m2, p<0.005), inotropy (2.14 vs 1.72 W/m2, p<0.01) and DO2I (679.8 vs 530.7 ml/min/m2, p<0.01), and a significantly lower potential to kinetic energy ratio (PKR) (43.0 vs 56.6, p<0.05). Moreover, the 30-day readmission rate was the highest in GOPD IV patients. Based on the existing findings, it would be interesting to study the long-term prognostic effect of haemodynamic parameters in COPD patients.
Aim
The aims of the present study for patients visited respiratory clinic or admitted to the Emergency Department (ED), including those admitted to resuscitation room or emergency high dependency unit, are:
- To investigate whether there is any correlation between haemodynamic parameters and COPD severity.
- To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 6-month, 1-year, 3-year and 5-year readmission.
- To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 6-month, 1-year, 3-year and 5-year all-cause mortality.
Measurements
- Haemodynamic measurements using an Ultrasonic Cardiac Output Monitor (USCOM®; USCOM Pty Ltd, NSW, Australia)
- Lung function assessment using Spirometry (MICROLAB 3300 spirometer; Micro Medical, Kent, UK)
- 6-minute walk test
- Borg dyspnoea scale
- Blood pressure
- End-tidal CO2
Definition of haemodynamic parameters:
- Velocity time integral (vti) is the integral of the flow profile, i.e. the distance the blood travels in one beat. The unit of vti is m/s.
- Cardiac output (CO) is the volume of blood pumped by the heart in one minute: CO = SV x HR. The unit is l/min.
- Cardiac index (CI) is equal to CO divided by BSA. The unit is l/min/m2.
- Stroke volume (SV) is the volume of blood ejected from the heart during one systolic stroke. SV = vti x πr2,where πr2 = flow cross sectional area. The unit of SV is ml.
- Stroke volume index (SVI) is SV divided by BSA and the unit is ml/m2.
- Stroke volume variation (SVV) is the percentage change in SV between a group of beats. SVV = (SVmax - SVmin x 100) / [(SVmax + SVmin)/2].
- Systemic vascular resistance (SVR) is the pressure against which the heart pumps. SVR = MAP/CO. The unit is d.s.cm-5.
- Systemic vascular resistance index (SVRI) SVRI = SVR x BSA d.s.cm-5m2.
- Oxygen delivery (DO2) is calculated by the equation: DO2 = 1.34 x Hb x SpO2/100 x CO, where Hb = hemoglobin in grams of hemoglobin per litre of blood (g/l); SpO2 = the peripheral oxygen saturation as a percentage (%). The unit of DO2 is ml/min.
- Oxygen delivery index (DO2I) is equal to DO2 divided by BSA. The unit of DO2I is ml/min/m2.
- Inotropy index refers to (Potential energy + Kinetic energy) divided by body surface area. The unit of inotropy is W/m2.
- Potential to kinetic energy ratio (PKR) is the energy used to produce blood pressure divided by the energy used to produce blood flow.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stable COPD patients | – | Device: Ultrasonic Cardiac Output Monitor, Device: SpirometryPatients will be assessed using USCOM and spirometry. For those with FEV1 to FVC ratio smaller than 70%, they will be classified as COPD. |
| AECOPD patients | – | Device: Ultrasonic Cardiac Output Monitor, Device: SpirometryPatients will be assessed using USCOM and spirometry. Spirometry will be assessed after 2 to 4 weeks post-hospital discharge. |
| Patient Controls | – | Device: Ultrasonic Cardiac Output Monitor, Device: SpirometryPatients will be assessed using USCOM and spirometry. For those with COPD symptoms but FEV1 to FVC ratio greater than 70%, they will be classified as non-COPD. |
| Healthy Controls | – | Device: Ultrasonic Cardiac Output MonitorHealthy subjects, with no history of COPD or other significant chronic illness will be recruited as healthy controls. Subjects will be matched for age and gender with the patient groups. They will be assessed using USCOM. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a de novo diagnosis of COPD or a known history of COPD who attend a respiratory clinic or the emergency department in the Prince of Wales Hospital (Shatin, Hong Kong) will be recruited.
Key inclusion criteria (3 listed)
- Age >40 years;
- Clinically diagnosed as COPD by physicians;
- Obtain any one of exacerbating symptoms (increased dyspnoea, sputum production, sputum volume, wheeze, cough or exertional dyspnoea);
Key exclusion criteria (1 listed)
- Known or suspected pregnancy, lactating patients, active malignancies, severe mobility problems (e.g. significant painful arthritis), and confusion or dementia .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic Cardiac Output MonitorAlso: USCOMAn Ultrasonic Cardiac Output Monitor (USCOM; USCOM Pty Ltd, NSW, Australia) is a non-invasive Doppler ultrasonography. It is capable of measuring haemodynamic parameters non-invasively and appears to be simple and rapid to use, portable, relatively inexpensive and has less potential complications compared with the standard technique, pulmonary artery thermodilution (PATD). USCOM scans will be performed on patients to measure direct and derived haemodynamic variables, which will be performed in the supine position wherever possible. A transducer will be placed on the chest in either the suprasternal position to measure trans-aortic blood flow, or the left parasternal position to measure transpulmonary blood flow. | Device | AECOPD patients, Healthy Controls, Patient Controls, Stable COPD patients |
| SpirometryAlso: Lung function testSpirometry assesses lung function through measuring the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. Patients are regarded as COPD if their Forced expiratory volume in 1 second (FEV1) to Forced vital capacity (FVC) ratio are smaller than 70%. Patients were required to perform three blowing manoeuvres, and post-bronchodilator test results were obtained within 20 minutes to 4 hours after inhaling 400 mg of salbultamol. | Device | AECOPD patients, Patient Controls, Stable COPD patients |
Primary outcome
The difference in mean cardiac index (CI) among the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage I, II, III, IV and healthy subjects.
Time frame: On Day 1
5 secondary outcomes
The difference in velocity time interval (vti) obtained using USCOM among GOLD stage I, II, III, IV and healthy subjects
Time frame: On Day 1
The differences in USCOM-derived haemodynamic parameters, including CO, SV, SVI, SVV, SVR, SVRI, DO2, DO2I, Intropy and PKR obtained using USCOM among GOLD stage I, II, III, IV and healthy subjects
Time frame: On Day 1
The differences in USCOM-derived haemodynamic parameters, including CO, CI, SVR, SVRI, SVV, DO2, DO2I, Intropy and PKR between stable and acute exacerbated condition
Time frame: On Day 1
The number of 6-month, 1-year, 3-year and 5-year readmission in COPD patients
Time frame: Year 5
The number of 6-month, 1-year, 3-year and 5-year all-cause mortality in COPD patients
Time frame: Year 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Background: PubMed 18684847Ko FW, Woo J, Tam W, Lai CK, Ngai J, Kwok T, Hui DS. Prevalence and risk factors of airflow obstruction in an elderly Chinese population. Eur Respir J. 2008 Dec;32(6):1472-8. doi: 10.1183/09031936.00058708. Epub 2008 Aug 6.
- Background: PubMed 16113423Wedzicha JA. Role of viruses in exacerbations of chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2004;1(2):115-20. doi: 10.1513/pats.2306030.
- Background: PubMed 9163648Anderson HR, Spix C, Medina S, Schouten JP, Castellsague J, Rossi G, Zmirou D, Touloumi G, Wojtyniak B, Ponka A, Bacharova L, Schwartz J, Katsouyanni K. Air pollution and daily admissions for chronic obstructive pulmonary disease in 6 European cities: results from the APHEA project. Eur Respir J. 1997 May;10(5):1064-71. doi: 10.1183/09031936.97.10051064.
- Background: PubMed 15923248Wouters EF, Postma DS, Fokkens B, Hop WC, Prins J, Kuipers AF, Pasma HR, Hensing CA, Creutzberg EC; COSMIC (COPD and Seretide: a Multi-Center Intervention and Characterization) Study Group. Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial. Thorax. 2005 Jun;60(6):480-7. doi: 10.1136/thx.2004.034280.
- Background: PubMed 10362051Donaldson GC, Seemungal T, Jeffries DJ, Wedzicha JA. Effect of temperature on lung function and symptoms in chronic obstructive pulmonary disease. Eur Respir J. 1999 Apr;13(4):844-9. doi: 10.1034/j.1399-3003.1999.13d25.x.
- Background: PubMed 9039248Osman IM, Godden DJ, Friend JA, Legge JS, Douglas JG. Quality of life and hospital re-admission in patients with chronic obstructive pulmonary disease. Thorax. 1997 Jan;52(1):67-71. doi: 10.1136/thx.52.1.67.
- Background: PubMed 15763452Ko FW, Ng TK, Li TS, Fok JP, Chan MC, Wu AK, Hui DS. Sputum bacteriology in patients with acute exacerbations of COPD in Hong Kong. Respir Med. 2005 Apr;99(4):454-60. doi: 10.1016/j.rmed.2004.09.011.
- Background: PubMed 20920140Chang CL, Sullivan GD, Karalus NC, Mills GD, McLachlan JD, Hancox RJ. Predicting early mortality in acute exacerbation of chronic obstructive pulmonary disease using the CURB65 score. Respirology. 2011 Jan;16(1):146-51. doi: 10.1111/j.1440-1843.2010.01866.x.
- Background: PubMed 8625670Kiely DG, Cargill RI, Lipworth BJ. Effects of hypercapnia on hemodynamic, inotropic, lusitropic, and electrophysiologic indices in humans. Chest. 1996 May;109(5):1215-21. doi: 10.1378/chest.109.5.1215.
- Background: PubMed 23645929Smith BE, Madigan VM. Non-invasive method for rapid bedside estimation of inotropy: theory and preliminary clinical validation. Br J Anaesth. 2013 Oct;111(4):580-8. doi: 10.1093/bja/aet118. Epub 2013 May 3.
- Cardiovascular physiology conceptsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Timothy H Rainer, MD FCEM principal investigator
Accident & Emergency Medicine Academic Unit
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 Chronic Obstructive Pulmonary Disease, run by Chinese University of Hong Kong at 1 site in China.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Oct 2017. 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 China. 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?
Results are not available in the source record.
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?
The difference in mean cardiac index (CI) among the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage I, II, III, IV and healthy subjects. (time frame: On Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02329522, which also lists 10 linked publications.
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 2 Oct 2017.