NCT04659681

Brief 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 patients receiving Central venous pressure Guided and Pleth variability Index (PVI) guided fluids intraoperatively .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

April 5, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

December 2, 2020

Last Update Submit

April 2, 2021

Conditions

Extravascular Lung Water

Keywords

Lung Ultrasonography Extravascular Lung Water Plethysmography variability Index

Outcome Measures

Primary Outcomes (1)

  • 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

    End of surgery upto 1 hour

Secondary Outcomes (1)

  • Adequacy of Perfusion

    End of surgery upto 1 hour

Study Arms (2)

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.

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.

Diagnostic Test: CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given

Interventions

PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given .DIAGNOSTIC_TEST

PVI probe attached to finger in PVI Group

PVI Guided Fluid Therapy
CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be givenDIAGNOSTIC_TEST

Placement of central venous catheter

CVP Guided Fluid Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing major Oncosurgeries under General Anaesthesia

You may not qualify if:

  • Left ventricular ejection fraction (LVEF )\< 40%
  • Chronic Obstructive Pulmonary Disease (COPD)
  • BMI \>30
  • Lung fibrosis
  • Previous lung surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, 110085, India

Location

Related Publications (2)

  • 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.

    PMID: 27174289BACKGROUND

  • Anile 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.

    PMID: 28612302BACKGROUND

Study Officials

  • Anita C Kulkarni, MD

    Rajiv Gandhi Cancer Institute and Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant was masked about Group it belonged
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 9, 2020

Study Start

January 1, 2020

Primary Completion

January 10, 2021

Study Completion

January 20, 2021

Last Updated

April 5, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)