Plain English Summary
Background and study aims
Extravascular lung water refers to fluid within the lung. Increase in extravascular lung water is associated with death in very ill patients. The purpose of this study is to compare three methods of lung ultrasound with transpulmonary thermodilution technique.
Who can participate?
Individuals with septic shock, 18 years old or over
What does the study involve?
All patients will be assessed with three methods of lung ultrasound (total B-line scores, BLUE points and scanning eight regions) and the results will be compared with the transpulmonary thermodilution technique.
What are the possible benefits and risks of participating?
A benefit is improvement in the monitoring of the patients. The risks are bleeding, haematoma and pneumothorax.
Where is the study run from?
Phramongkutklao Hospital (Thailand)
When is study starting and how long is it expected to run for?
From March 2013 to July 2014
Who is funding the study?
Phramongkutklao Hospital Foundation Under Her Royal Highness Princess Maha Chakri Sirindhorn Patronage (Thailand)
Who is the main contact?
Dr. Pattarin Pirompanich
Trial website
Contact information
Type
Public
Primary contact
Dr Pattarin Pirompanich
ORCID ID
http://orcid.org/0000-0003-0181-5394
Contact details
Division of Pulmonary and Critical Care Medicine
Department of Internal Medicine
Faculty of Medicine
Thammasat University
Klong 1
Klong Luang
Pathumthani
12120
Thailand
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparison of three methods of lung ultrasound with the transpulmonary thermodilution technique for assessment of extravascular lung water in patients with septic shock
Acronym
Study hypothesis
Extravascular lung water index greater than 10 mL/kg in patients with cardiogenic pulmonary oedema correlates with pulmonary capillary wedge pressure of greater than 20 mm Hg. Measurement of extravascular lung water needs sophisticated tools and use of the invasive transpulmonary thermodilution technique. By contrast, multiple B-lines by transthoracic portable ultrasound have been recently proposed to correlate with increased extravascular lung water in patients with cardiogenic pulmonary oedema.
Lung ultrasound has a good correlation with transpulmonary thermodilution technique for the assessment of extravascular lung water in patients with septic shock.
Ethics approval
Institutional review board of the Royal Thai Army Medical Department, 22/04/2009
Reference number: R032h/56
Study design
Cross sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Septic shock
Intervention
1. Total B-line scores
2. BLUE points
3. Scanning eight regions
These three methods of lung ultrasound were used on each patient to assess extravascular lung water and the results were compared with those from obtained with the transpulmonary thermodilution technique.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Best method of lung ultrasound to diagnose pulmonary oedema in patients with septic shock: cutoff point of extravascular water index measured by transpulmonary thermodilution greater than
10 mL/kg predicted bodyweight, which is correlated with a pulmonary capillary wedge pressure of greater than 20 mmHg to indicate pulmonary oedema
Secondary outcome measures
Cutoff point of total B-line scores to predict extravascular lung water index of 10 mL/kg or more
Overall trial start date
01/03/2013
Overall trial end date
30/07/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18 years old or over
2. Septic shock requiring central venous catheterisation and arterial catheterisation for continuous pressure monitoring
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 comparisons from 17 patients
Participant exclusion criteria
1. Valvular heart disease
2. Pregnancy
3. Acute or history of pulmonary embolism
4. Lung resection surgery
5. Acute respiratory distress syndrome
6. Interstitial lung diseases
7. Mulitilobar pneumonia
8. Pleural diseases
Recruitment start date
01/09/2013
Recruitment end date
30/06/2014
Locations
Countries of recruitment
Thailand
Trial participating centre
Phramongkutklao Hospital
315 Phayathai Road
Ratchathewi
Bangkok
10400
Thailand
Sponsor information
Organisation
Phramongkutklao Hospital Foundation Under Her Royal Highness Princess Maha Chakri Sirindhorn Patronage
Sponsor details
315 Phayathai Road
Ratchathewi
ฺBangkok
10400
Thailand
+6623543699
foundation_pmk@hotmail.com
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Phramongkutklao Hospital Foundation Under Her Royal Highness Princess Maha Chakri Sirindhorn Patronage
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publish the results in a few months
Intention to publish date
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30294131