Pulmonary CongestionNCT04417790
Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population
An observational study of Pulmonary Congestion and Congenital Heart Disease, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Increased extravascular lung water (EVLW) may increase mortality and morbidity in cardiopulmonary pathology. Many factors can cause increased extravascular lung water and pulmonary edema after cardiac surgery. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Pulmonary Congestion, Congenital Heart Disease, Post-Op Complication
- What is being tested?
- Lung ultrasound and EVLW measurement by transpulmonary thermodilution.
- How many people
- 25 participants
- Where
- 1 siteIndia
- Study dates
- 10 Aug 2019to 30 Aug 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with cyanotic or acyanotic heart undergoing elective cardiac surgery.
Who may be able to join
- aged under 12 years,
- undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease,
- Aristotle score ≤9,
- with prior written informed consent
Who cannot join
- Neonates,
- Children with any chest wall deformity,
- children with known lung disease, active infection,
- those weighing less than 3.5 kg.
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education & Research
Chandigarh, 160012
About this study
Official title: Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population- a Prospective Observational Study
Increased extravascular lung water (EVLW) may increase mortality and morbidity in cardiopulmonary pathology. Many factors can cause increased extravascular lung water and pulmonary edema after cardiac surgery. This includes left ventricular failure, acute mitral regurgitation; systemic inflammatory response post-cardiopulmonary bypass, left to right shunts, transfusion associated acute lung injury, acute respiratory distress syndrome(ARDS) and sepsis.
The clinical assessment of lung water ranges from auscultation to radiological methods to invasive measurements like dye dilution or thermodilution studies.
Read more
Lung ultrasonography is the newest modality for noninvasive assessment of extravascular lung water. Lung ultrasound has been validated against auscultation, chest X-rays, CT chest as well as the bedside gold standard, transpulmonary thermodilution in adults.
Critically ill children are more susceptible to complications and worsened outcomes from increased EVLW.
Lung ultrasound correlates with clinical and radiological endpoints, but has not been validated against invasive objective measures like transpulmonary thermodilution.
Evaluation of transpulmonary thermodilution setups in the pediatric population has shown different normal values and cutoffs compared to adults, possibly due to differential rates growth and development.
It is aimed to investigate the correlation of Lung ultrasound based indices of extravascular lung water to invasive measures, assess optimum cutoffs to appropriate clinical endpoints and evaluate their sensitivity and specificity.
- Being tested
- Lung ultrasound and EVLW measurement by transpulmonary thermodilution.
- Keywords
- Lung ultrasound, Transpulmonary thermodilution
- Medical subject headings
- Heart Defects, Congenital, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound and EVLW measurement by transpulmonary thermodilution.Diagnostic test
Lung ultrasonography by 8 Quadrant protocol of Volpicelli et al. Transpulmonary thermodilution for extravascular lung water measurement
| Study group | Role | What they receive |
|---|---|---|
| Study population | Children under 12 years of age, Undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease, Aristotle score ≤9, Giving prior written informed consent. Receives: Diagnostic Test: Lung ultrasound and EVLW measurement by transpulmonary thermodilution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of lung USG B-line score with PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.
Measured: Till extubation or second post-operative day.
cutoffs for lung USG B-line score to Predict abnormal EVLWI values.
Measured: Till extubation or second post-operative day.
Secondary outcomes (1)
trending ability of lung USG B-line score to predict PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.
Measured: Till extubation or second post-operative day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start10 Aug 2019
- Primary completion15 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary CongestionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Subhrashis Guha Niyogi, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Bhupesh Kumar, DM, Study director, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417790
- Sponsor's protocol ID
- INT/IEC/2019/001513
- Status last verified
- Sep 2020
- First submitted
- 2 Jun 2020
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population- a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04417790
- Acronym / sponsor ID
- INT/IEC/2019/001513
- Keywords
- Lung ultrasound, Transpulmonary thermodilution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 10 Aug 2019 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 5 Jun 2020 (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.
Increased extravascular lung water (EVLW) may increase mortality and morbidity in cardiopulmonary pathology. Many factors can cause increased extravascular lung water and pulmonary edema after cardiac surgery. This includes left ventricular failure, acute mitral regurgitation; systemic inflammatory response post-cardiopulmonary bypass, left to right shunts, transfusion associated acute lung injury, acute respiratory distress syndrome(ARDS) and sepsis.
The clinical assessment of lung water ranges from auscultation to radiological methods to invasive measurements like dye dilution or thermodilution studies.
Lung ultrasonography is the newest modality for noninvasive assessment of extravascular lung water. Lung ultrasound has been validated against auscultation, chest X-rays, CT chest as well as the bedside gold standard, transpulmonary thermodilution in adults.
Critically ill children are more susceptible to complications and worsened outcomes from increased EVLW.
Lung ultrasound correlates with clinical and radiological endpoints, but has not been validated against invasive objective measures like transpulmonary thermodilution.
Evaluation of transpulmonary thermodilution setups in the pediatric population has shown different normal values and cutoffs compared to adults, possibly due to differential rates growth and development.
It is aimed to investigate the correlation of Lung ultrasound based indices of extravascular lung water to invasive measures, assess optimum cutoffs to appropriate clinical endpoints and evaluate their sensitivity and specificity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Diagnostic Test: Lung ultrasound and EVLW measurement by transpulmonary thermodilution.Children under 12 years of age, Undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease, Aristotle score ≤9, Giving prior written informed consent. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with cyanotic or acyanotic heart undergoing elective cardiac surgery.
Key inclusion criteria (4 listed)
- aged under 12 years,
- undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease,
- Aristotle score ≤9,
- with prior written informed consent
Key exclusion criteria (4 listed)
- Neonates,
- Children with any chest wall deformity,
- children with known lung disease, active infection,
- those weighing less than 3.5 kg.
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 |
|---|---|---|
| Lung ultrasound and EVLW measurement by transpulmonary thermodilution.Lung ultrasonography by 8 Quadrant protocol of Volpicelli et al. Transpulmonary thermodilution for extravascular lung water measurement | Diagnostic test | Study population |
Primary outcome
correlation of lung USG B-line score with PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.
Time frame: Till extubation or second post-operative day.
cutoffs for lung USG B-line score to Predict abnormal EVLWI values.
Time frame: Till extubation or second post-operative day.
1 secondary outcome
trending ability of lung USG B-line score to predict PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients.
Time frame: Till extubation or second post-operative day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Bhupesh Kumar, DM study director
Post Graduate Institute of Medical Education and Research, Chandigarh
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 Pulmonary Congestion and Congenital Heart Disease, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 14 Sep 2020. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
correlation of lung USG B-line score with PICCO derived EVLW / EVLWI in pediatric cardiac surgical patients. (time frame: Till extubation or second post-operative day.). The study lists 2 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 14 Sep 2020.