Extravascular Lung WaterLUS EVLWNCT04659681
Role of Lung Ultrasonography in Detecting Extravascular Lung Water in Major Oncosurgeries
A study testing PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given . and CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given in people with Extravascular Lung Water, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
During major surgeries optimal intravenous fluid administration is essential , conventional method may cause fluid overload , increased extravascular Lung water can lead to postoperative cardio-respiratory complications , this study was designed to detect immediate postoperative EVLW with Lung Ultrasonography in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Extravascular Lung Water
- What is being tested?
- PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given . and CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2020to 20 Jan 2021
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing major Oncosurgeries under General Anaesthesia
Who cannot join
- Left ventricular ejection fraction (LVEF )< 40%
- Chronic Obstructive Pulmonary Disease (COPD)
- BMI >30
- Lung fibrosis
- Previous lung surgery
Trial locations and contacts
1 site in 1 country.
About this study
During major surgeries optimal intravenous fluid administration is essential , conventional method may cause fluid overload , increased extravascular Lung water can lead to postoperative cardio-respiratory complications , this study was designed to detect immediate postoperative EVLW with Lung Ultrasonography in patients receiving Central venous pressure Guided and Pleth variability Index (PVI) guided fluids intraoperatively .
Read the detailed description
Standard General Anaesthesia with Endotracheal Tube and Intermittent Positive Pressure Ventilation (IPPV) was given to all patients,Monitoring included 5 lead ECG, Oxygen Saturation (SPO2), End tidal Carbon di oxide (ETCO2), Invasive Blood Pressure (IBP) , Central venous Pressure (CVP), Pleth variability Index (PVI) in study group and Bispectral Index (BIS) , Core temperature .Postintubation before commencement of surgery baseline Lung Ultrasonography will be performed with non-linear probe in 4 zones on Right and Left Lung-- Zone I Right Midclavicular in second intercostal space , Zone II Right Parasternal in third intercostal space, Zone III Anterior axillary line in fourth intercostal space Zone IV Posterior axillary line in the V intercostal space. Zone V to VIII in Corresponding spaces on the Left side . In the control Group CVP Guided IV fluids were given during surgery CVP will be maintained between 10-16 cms H20 , for CVP values < 10 cms H20 colloid bolus 200ml was given.In the Study Group PVI guided IV Fluids will be given to maintain PVI <12 for increase in PVI value > 12 Colloid bolus 200 ml will be given. After the completion of surgery and before extubation Lung Ultrasonography will be performed in all 8 Zones in both lungs to identify B Lines and total number of B lines will be calculated , Extra Vascular Lung Water (EVLW) Grading will be done as B Lines <5 Mild, between 5-15 moderate , > 15 severe .Total IV Fluids along with colloid boluses will be calculated , Postintubation as Baseline and after the completion of surgery Arterial blood gas analysis will be done for Alveolar-Arterial Oxygenation Pa02 (A-a) and blood Lactate values . After completion of surgery neuromuscular blockade will be reversed and trachea extubated .
- Conditions
- Extravascular Lung Water
- Being tested
- PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given ., CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given
- Keywords
- Lung Ultrasonography Extravascular Lung Water Plethysmography variability Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given .Diagnostic test
PVI probe attached to finger in PVI Group
CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be givenDiagnostic test
Placement of central venous catheter
| Study group | Role | What they receive |
|---|---|---|
| PVI Guided Fluid Therapy | Active comparator | Patients will receive PVI guided fluids during surgery PVI to be maintained below 12% if PVI >12 then colloid bolus 200ml will be given. Lung Ultrasonography will be performed post-intubation as baseline and at the end of surgery before extubation in 4 Lung zones in both lungs to measure total number of B-lines. Receives: Diagnostic Test: PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given . |
| CVP Guided Fluid Therapy | Active comparator | Patients will receive Standard CVP Guided Fluids , CVP maintained between 10-16 cms H20 , if CVP< 10 then colloid bolus 200ml will be given. Lung Ultrasonography will be performed post-intubation as baseline and at the end of surgery before extubation in 4 zones in both lungs to measure total number of B-lines. Receives: Diagnostic Test: CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extravascular Lung Water detection
At the end of surgery before extubation Lung Ultrasonography will be performed in 4 Zones bilaterally to detect total number of B lines in both groups
Measured: End of surgery upto 1 hour
Secondary outcomes (1)
Adequacy of Perfusion
Serum Blood Lactate levels will be measured at end of surgery in both groups.
Measured: End of surgery upto 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Jan 2020
- Primary completion10 Jan 2021
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Extravascular Lung WaterStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Anita C Kulkarni, MD, Principal investigator, Rajiv Gandhi Cancer Institute and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659681
- Sponsor's protocol ID
- RajivGCIRC LUS
- Acronym
- LUS EVLW
- Status last verified
- Apr 2021
- First submitted
- 2 Dec 2020
- Last updated
- 5 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Picano E, Pellikka PA. Ultrasound of extravascular lung water: a new standard for pulmonary congestion. Eur Heart J. 2016 Jul 14;37(27):2097-104. doi: 10.1093/eurheartj/ehw164. Epub 2016 May 12.
PubMed 27174289Anile A, Russo J, Castiglione G, Volpicelli G. A simplified lung ultrasound approach to detect increased extravascular lung water in critically ill patients. Crit Ultrasound J. 2017 Dec;9(1):13. doi: 10.1186/s13089-017-0068-x. Epub 2017 Jun 13.
PubMed 28612302
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lung Ultrasonography in Detecting Extravascular Lung Water in Major Oncosurgeries
- ClinicalTrials.gov ID
- NCT04659681
- Acronym / sponsor ID
- LUS EVLW / RajivGCIRC LUS
- Conditions
- Extravascular Lung Water
- Keywords
- Lung Ultrasonography Extravascular Lung Water Plethysmography variability Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 9 Dec 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.
During major surgeries optimal intravenous fluid administration is essential , conventional method may cause fluid overload , increased extravascular Lung water can lead to postoperative cardio-respiratory complications , this study was designed to detect immediate postoperative EVLW with Lung Ultrasonography in patients receiving Central venous pressure Guided and Pleth variability Index (PVI) guided fluids intraoperatively .
Detailed description
Standard General Anaesthesia with Endotracheal Tube and Intermittent Positive Pressure Ventilation (IPPV) was given to all patients,Monitoring included 5 lead ECG, Oxygen Saturation (SPO2), End tidal Carbon di oxide (ETCO2), Invasive Blood Pressure (IBP) , Central venous Pressure (CVP), Pleth variability Index (PVI) in study group and Bispectral Index (BIS) , Core temperature .Postintubation before commencement of surgery baseline Lung Ultrasonography will be performed with non-linear probe in 4 zones on Right and Left Lung-- Zone I Right Midclavicular in second intercostal space , Zone II Right Parasternal in third intercostal space, Zone III Anterior axillary line in fourth intercostal space Zone IV Posterior axillary line in the V intercostal space. Zone V to VIII in Corresponding spaces on the Left side . In the control Group CVP Guided IV fluids were given during surgery CVP will be maintained between 10-16 cms H20 , for CVP values < 10 cms H20 colloid bolus 200ml was given.In the Study Group PVI guided IV Fluids will be given to maintain PVI <12 for increase in PVI value > 12 Colloid bolus 200 ml will be given. After the completion of surgery and before extubation Lung Ultrasonography will be performed in all 8 Zones in both lungs to identify B Lines and total number of B lines will be calculated , Extra Vascular Lung Water (EVLW) Grading will be done as B Lines <5 Mild, between 5-15 moderate , > 15 severe .Total IV Fluids along with colloid boluses will be calculated , Postintubation as Baseline and after the completion of surgery Arterial blood gas analysis will be done for Alveolar-Arterial Oxygenation Pa02 (A-a) and blood Lactate values . After completion of surgery neuromuscular blockade will be reversed and trachea extubated .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI Guided Fluid Therapy | Active comparator | Diagnostic Test: PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given .Patients will receive PVI guided fluids during surgery PVI to be maintained below 12% if PVI >12 then colloid bolus 200ml will be given. Lung Ultrasonography will be performed post-intubation as baseline and at the end of surgery before extubation in 4 Lung zones in both lungs to measure total number of B-lines. |
| CVP Guided Fluid Therapy | Active comparator | Diagnostic Test: CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be givenPatients will receive Standard CVP Guided Fluids , CVP maintained between 10-16 cms H20 , if CVP< 10 then colloid bolus 200ml will be given. Lung Ultrasonography will be performed post-intubation as baseline and at the end of surgery before extubation in 4 zones in both lungs to measure total number of B-lines. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing major Oncosurgeries under General Anaesthesia
Key exclusion criteria (5 listed)
- Left ventricular ejection fraction (LVEF )< 40%
- Chronic Obstructive Pulmonary Disease (COPD)
- BMI >30
- Lung fibrosis
- Previous lung surgery
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 |
|---|---|---|
| PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given .PVI probe attached to finger in PVI Group | Diagnostic test | PVI Guided Fluid Therapy |
| CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be givenPlacement of central venous catheter | Diagnostic test | CVP Guided Fluid Therapy |
Primary outcome
Extravascular Lung Water detection
Time frame: End of surgery upto 1 hour
At the end of surgery before extubation Lung Ultrasonography will be performed in 4 Zones bilaterally to detect total number of B lines in both groups
1 secondary outcome
Adequacy of Perfusion
Time frame: End of surgery upto 1 hour
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 5 Apr 2021.
- Background: PubMed 27174289Picano E, Pellikka PA. Ultrasound of extravascular lung water: a new standard for pulmonary congestion. Eur Heart J. 2016 Jul 14;37(27):2097-104. doi: 10.1093/eurheartj/ehw164. Epub 2016 May 12.
- Background: PubMed 28612302Anile A, Russo J, Castiglione G, Volpicelli G. A simplified lung ultrasound approach to detect increased extravascular lung water in critically ill patients. Crit Ultrasound J. 2017 Dec;9(1):13. doi: 10.1186/s13089-017-0068-x. Epub 2017 Jun 13.
- Individual participant dataSharing planned: No
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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.
Anita C Kulkarni, MD principal investigator
Rajiv Gandhi Cancer Institute and Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given . and CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given in people with Extravascular Lung Water, run by Rajiv Gandhi Cancer Institute & Research Center, India 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 1 inclusion and 5 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 5 Apr 2021. 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?
Extravascular Lung Water detection (time frame: End of surgery upto 1 hour). 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 NCT04659681, which also lists 2 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 5 Apr 2021.