USCOM For Assessing Patients With COPD

NCT02329522 | Unknown

• 1 other identifier: 2013.640
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 1.To investigate whether there is any correlation between haemodynamic parameters and COPD severity.
2. 2.To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 6-month, 1-year, 3-year and 5-year readmission.
3. 3.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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Haemodynamics; Chronic obstructive pulmonary disease; Ultrasonic Cardiac Output Monitor; severity

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  On Day 1

• The number of 6-month, 1-year, 3-year and 5-year readmission in COPD patients

  Year 5

• The number of 6-month, 1-year, 3-year and 5-year all-cause mortality in COPD patients

  Year 5

Study Arms (4)

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.

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.

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.

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.

Device: Ultrasonic Cardiac Output Monitor

Interventions

Ultrasonic Cardiac Output Monitor DEVICE

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.

Also known as: USCOM

AECOPD patients; Healthy Controls; Patient Controls; Stable COPD patients

Spirometry DEVICE

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.

Also known as: Lung function test

AECOPD patients; Patient Controls; Stable COPD patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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);

You may not qualify if:

• Known or suspected pregnancy, lactating patients, active malignancies, severe mobility problems (e.g. significant painful arthritis), and confusion or dementia .

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (10)

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  PMID: 9163648 BACKGROUND

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  PMID: 15923248 BACKGROUND

• Donaldson 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.

  PMID: 10362051 BACKGROUND

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  PMID: 9039248 BACKGROUND

• Ko 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.

  PMID: 15763452 BACKGROUND

• Chang 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.

  PMID: 20920140 BACKGROUND

• Kiely 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.

  PMID: 8625670 BACKGROUND

• Smith 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.

  PMID: 23645929 BACKGROUND

Related Links

• Cardiovascular physiology concepts

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spirometry; Respiratory Function Tests

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Timothy H Rainer, MD FCEM

  Accident & Emergency Medicine Academic Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director & Professor

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: December 31, 2014
• Study Start: February 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: September 1, 2020
• Last Updated: October 2, 2017

Record last verified: 2017-09

Locations

CN (1)