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Lung Ultrasound Score and Inferior Vena Cava Diameter Compared to Pulse Pressure Variation

Primary Purpose

Sepsis, Critical Illness

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
normal Saline
lung ultrasound
inferior vena cava measurements
passive leg raising test (PLRT)
pulse pressure variation
Sponsored by
Fayoum University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sepsis focused on measuring lung utlrasound, pulse pressure variation, inferior vena cava, fluid responsiveness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients on mechanical ventilation (MV). Aged more than 18 years. Mean arterial pressure (MAP) less than 65 mmHg or systolic arterial pressure less than 90mm Hg with signs of hypoperfusion (urinary flow < 0.5mL/kg/ h for > 2hr , tachycardia > 100 beats/min, or presence of skin mottling , and seurm lactate more than 2 mmol/L). Exclusion Criteria: Cardiac arrhythmias. Previously known significant valvular disease or intracardiac shunt. Chest drains. Increasing intra abdominal pressure. Prephiral vascular disesaes. Adult respiratory distress syndrome (ARDS) patients due to low tidal volume. Interstitial lung disease because B-lines in these conditions are the consequence of the thickened interlobular septa characterizing fibrosis and are not modified by the state of hydration or imbibition 12 Any contraindication for fluid administration as cardiogenic shock, acute pulmonary edema or LVEF% less than 50%. Renal patients with oliguria and volume overload including patients on hemodialysis or patients with acute anuric renal failure. Patients with lower extremity artery/vein thrombosis, significant lower extremity artery plaque, lower extremity artery occlusion, inferior vena cava filter implantation and lower extremity varicose veins.

Sites / Locations

  • Fayoum University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Scanning group

Arm Description

Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study.

Outcomes

Primary Outcome Measures

The sensitivity of lung ultrasound in predicting fluid responsiveness.
<0.8: non-sensitive, >0.8: sensitive

Secondary Outcome Measures

lung ultrasound B lines score
(0) Normal aeration: A lines with lung sliding or fewer than two isolated B lines Moderate loss of lung aeration: well-defined, multiple B lines. Severe loss of lung aeration: multiple coalescent B lines. Complete loss of lung aeration or lung consolidation. This will be used to calculate total LUS-score (calculated as a sum of all quadrants score) and individual areas score (Ant, Lt and Post).
Inferior vena cava distensibility index.
(maximum diameter - minimum diameter)/minimum diameter.
pulse pressure variation
in percent
central venous pressure
in centimeter water
heart rate
in beat per minute
serum lactate
in ml equivalent per liter
urine output
in ml/ hour
length of stay in ICU
in days
specificity of lung ultrasound predicting fluid responsiveness
<0.8 non specific > 0.8 specific
sensitivity of IVC ultrasound predicting fluid responsiveness
<0.8 non sensitive >0.8 sensitive
sensitivity of pulse pressure variation predicting fluid responsiveness
<0.8 non sensitive >0.8 sensitive
specificity of IVC ultrasound predicting fluid responsiveness
<0.8 non sensitive >0.8 sensitive
specificity of pulse pressure variation predicting fluid responsiveness
<0.8 non sensitive >0.8 sensitive

Full Information

First Posted
July 31, 2023
Last Updated
August 19, 2023
Sponsor
Fayoum University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05980494
Brief Title
Lung Ultrasound Score and Inferior Vena Cava Diameter Compared to Pulse Pressure Variation
Official Title
Validity of Lung Ultrasound Score and Inferior Vena Cava Diameter Compared to Pulse Pressure Variation Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Patients: a Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2022 (Actual)
Primary Completion Date
March 20, 2024 (Anticipated)
Study Completion Date
April 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Evaluation and management of intravascular volume are a central challenge for the critical ill patients. Hypotensive patients are commonly resuscitated with intravenous crystalloid fluid as a recommendation for treatment of many shock states. There has been a growing interest in the implementation of lung ultrasound in critical care management in the last decade as it is easy, bedside, non-expensive, non invasive and radiation free. The object of the current study is to assess the ability of lung and inferior vena cava sonography versus pulse pressure variation to predict fluid responsiveness in patients with circulatory failure on mechanical ventilation.
Detailed Description
The study will be conducted in intensive care units of Fayoum University Hospitals after approval of the local institutional ethics committee and local institutional review board. Hypotensive Patients on mechanical ventilation starting from August 2022 will be enrolled in this prospective study until fulfilling sample size. A detailed informed consent will be signed before recruitment. All patients who fulfilled inclusion criteria will be monitored by: 6 leads ECG, Blood pressure, Urinary catheter for urine output, Pulse oximter.Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study. The Consolidated standards of Reporting Trials (CONSORT) recommendation will be followed. LUS and IVC measurements were performed by using a convex ultrasound probe (Philips clear vue350, Philips healthcare, Andover MAO1810, USA, Machine ID: 1385). LUS will be performed by an experienced radiologist according to standardized protocols. For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines for a total of 28 sectors will be identified. Each one will be divided into upper and lower halves, making a sum of 6 different quadrants for each side: anterior superior, anterior inferior, lateral superior, lateral inferior, posterior superior, posterior inferior. Ultrasound examination of the anterolateral chest was carried out with longitudinal scan of the right and left hemi thoraces, from the second to the fourth (on the right side to the fifth) intercostal space, as previously described. For each quadrant a score will be assigned based on B lines which are defined as an echogenic artifact with a narrow origin on the pleural line, deepening to the inferior border of the screen and coherent with respiratory movements indicating subpleural interstitial edema as follows: (0) Normal aeration: A lines with lung sliding or fewer than two isolated B lines Moderate loss of lung aeration: well-defined, multiple B lines. Severe loss of lung aeration: multiple coalescent B lines. Complete loss of lung aeration or lung consolidation. This will be used to calculate total LUS-score (calculated as a sum of all quadrants score) and individual areas score (Ant, Lt and Post). IVC US: The inferior vena cava was explored in the subxiphoid window in its sagittal view-just below the junction between the inferior vena cava and suprahepatic veins which lie approximately 0.5 to 3 cm from the right atrium, following the American Society of Echocardiography guidelines.; The (IVC distensibility index (dIVC) was calculated as (maximum diameter - minimum diameter)/minimum diameter. PPV: patients will be temporarily sedated and paralyzed and on fully controlled mechanical ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator waveform monitor ensuring that the respiratory changes in arterial pressure reflected only the effects of positive pressure ventilation. Modes of ventilation is selected to volume or pressure controlled ventilation, depending on the decision of the primary physicians. A tidal volume will be not less than 8 ml/ kg (predicted body weight). The preset respiratory rate will be at 14 breath/min. Positive end expiratory pressure (PEEP) will be between 8 and 10 cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV is calculated directly on Nihon Kohden monitores at base line. • Sample size: Sample size was calculated using MedCalc Statistical Software version 20 (MedCalc Software, Ostend, Belgium. Minimal sample size of patients was 118 patients with 59 responsive cases and 59 non-responsive cases. Calculation is guided by AUC of 0.915 obtained from a study in comparison to a null value of 0.8, with alpha of 0.05 and power of 90%. Sample size will be increased to 150 patients to increase precision and ensure that at least 59 responsive and 59 non-responsive cases are included. • Statistical analysis: Data will be collected and coded using Microsoft Excel and data analysis will be performed using IBM SPSS version 28 for Windows. Descriptive statistics will be presented in the form of numbers and percentages of categorical data, while means with standard deviations or medians with interquartile ranges will be used for numerical data variables. ROC curve will be used to estimate the appropriate cut off point for the inferior vena cava distensibility index, and for the lung ultrasound score. Area under the curve (AUC) will be reported and will be used to compare the diagnostic ability of different tests. Sensitivity, specificity, positive predictive value and negative predictive value will be reported with the 95% confidence intervals. P-value < 0.05 will be considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Critical Illness
Keywords
lung utlrasound, pulse pressure variation, inferior vena cava, fluid responsiveness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Scanning group
Arm Type
Experimental
Arm Description
Lung ultrasound (LUS), Inferior vena cava ultrasound (IVC US) and pulse pressure variation (PPV) will be done to every patient in the study.
Intervention Type
Drug
Intervention Name(s)
normal Saline
Other Intervention Name(s)
Fluid challenge test
Intervention Description
normal saline cyrstalloids infusion with rate of 4ml/kg /h for 3 hours
Intervention Type
Device
Intervention Name(s)
lung ultrasound
Intervention Description
Lung ultrasound by Philips clear vue350, Philips healthcare, Andover MAO1810, USA, Machine ID:1385 will scan For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines for a total of 28 sectors will be identified
Intervention Type
Device
Intervention Name(s)
inferior vena cava measurements
Intervention Description
The inferior vena cava was explored in the subxiphoid window in its sagittal view-just below the junction between the inferior vena cava and suprahepatic veins which lie approximately 0.5 to 3 cm from the right atrium, following the American Society of Echocardiography guidelines.; The (IVC distensibility index (dIVC) was calculated as (maximum diameter - minimum diameter)/minimum diameter.
Intervention Type
Diagnostic Test
Intervention Name(s)
passive leg raising test (PLRT)
Intervention Description
Regardless of CVP (i.e., during "blind PLR"), noninvasiveΔPLR systolic arterial pressure (SAP) more than 17% reliably identify fluid responders. During "CVP-guided PLR", in case of sufficient change in CVP (at least of 2 mmHg), noninvasiveΔPLR SAP perform better (cutoff of 9%). These findings, in sedated patients who had already undergone volume expansion and/or catecholamines, have to be verified during the early phase of circulatory failure (before an arterial line).
Intervention Type
Device
Intervention Name(s)
pulse pressure variation
Intervention Description
patients will be temporarily sedated and paralyzed and on fully controlled mechanical ventilation. No spontaneous breathing effort will be detected on the mechanical ventilator waveform monitor ensuring that the respiratory changes in arterial pressure reflected only the effects of positive pressure ventilation. Modes of ventilation is selected to volume or pressure controlled ventilation, depending on the decision of the primary physicians. A tidal volume will be not less than 8 ml/ kg (predicted body weight). The preset respiratory rate will be at 14 breath/min. Positive end expiratory pressure (PEEP) will be between 8 and 10 cmH2O. The plateau pressure was kept at below 30 cmH2O. In all patients, radial artery cannulation will be done for invasive blood pressure monitoring (using a 20 G cannula), PPV is calculated directly on Nihon Kohden monitores at base line.
Primary Outcome Measure Information:
Title
The sensitivity of lung ultrasound in predicting fluid responsiveness.
Description
<0.8: non-sensitive, >0.8: sensitive
Time Frame
After 5 minutes of admission
Secondary Outcome Measure Information:
Title
lung ultrasound B lines score
Description
(0) Normal aeration: A lines with lung sliding or fewer than two isolated B lines Moderate loss of lung aeration: well-defined, multiple B lines. Severe loss of lung aeration: multiple coalescent B lines. Complete loss of lung aeration or lung consolidation. This will be used to calculate total LUS-score (calculated as a sum of all quadrants score) and individual areas score (Ant, Lt and Post).
Time Frame
after 5 minutes of admission
Title
Inferior vena cava distensibility index.
Description
(maximum diameter - minimum diameter)/minimum diameter.
Time Frame
after 10 minutes of admission
Title
pulse pressure variation
Description
in percent
Time Frame
15 minutes after admission
Title
central venous pressure
Description
in centimeter water
Time Frame
after 20 minutes of admission
Title
heart rate
Description
in beat per minute
Time Frame
5 minutes after admission
Title
serum lactate
Description
in ml equivalent per liter
Time Frame
after 30 minutes of admission
Title
urine output
Description
in ml/ hour
Time Frame
in 1 hour after admission
Title
length of stay in ICU
Description
in days
Time Frame
1 hour after discharge
Title
specificity of lung ultrasound predicting fluid responsiveness
Description
<0.8 non specific > 0.8 specific
Time Frame
5 minutes after admission
Title
sensitivity of IVC ultrasound predicting fluid responsiveness
Description
<0.8 non sensitive >0.8 sensitive
Time Frame
after 5 minutes of admission
Title
sensitivity of pulse pressure variation predicting fluid responsiveness
Description
<0.8 non sensitive >0.8 sensitive
Time Frame
after 5 minutes of admission
Title
specificity of IVC ultrasound predicting fluid responsiveness
Description
<0.8 non sensitive >0.8 sensitive
Time Frame
after 5 minutes of admission
Title
specificity of pulse pressure variation predicting fluid responsiveness
Description
<0.8 non sensitive >0.8 sensitive
Time Frame
after 5 minutes of admission
Other Pre-specified Outcome Measures:
Title
weight
Description
in kilogram
Time Frame
5 minutes before admission
Title
height
Description
in centimeters
Time Frame
5 minutes before admission
Title
body mass index
Description
in kilogram/m2
Time Frame
5 minutes before admission
Title
age
Description
in years
Time Frame
5 minutes before admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients on mechanical ventilation (MV). Aged more than 18 years. Mean arterial pressure (MAP) less than 65 mmHg or systolic arterial pressure less than 90mm Hg with signs of hypoperfusion (urinary flow < 0.5mL/kg/ h for > 2hr , tachycardia > 100 beats/min, or presence of skin mottling , and seurm lactate more than 2 mmol/L). Exclusion Criteria: Cardiac arrhythmias. Previously known significant valvular disease or intracardiac shunt. Chest drains. Increasing intra abdominal pressure. Prephiral vascular disesaes. Adult respiratory distress syndrome (ARDS) patients due to low tidal volume. Interstitial lung disease because B-lines in these conditions are the consequence of the thickened interlobular septa characterizing fibrosis and are not modified by the state of hydration or imbibition 12 Any contraindication for fluid administration as cardiogenic shock, acute pulmonary edema or LVEF% less than 50%. Renal patients with oliguria and volume overload including patients on hemodialysis or patients with acute anuric renal failure. Patients with lower extremity artery/vein thrombosis, significant lower extremity artery plaque, lower extremity artery occlusion, inferior vena cava filter implantation and lower extremity varicose veins.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph M Botros, MD
Phone
0122758825
Ext
002
Email
dr_jo27@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed A hamed, MD
Phone
01010509736
Ext
002
Email
mah7@fayoum.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
omar S farghaly, MD
Organizational Affiliation
lecturer
Official's Role
Study Director
Facility Information:
Facility Name
Fayoum University Hospital
City
Fayoum
ZIP/Postal Code
63514
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed a hamed, MD
Phone
01010509736
Ext
002
Email
mah07@fayoum.edu.eg
First Name & Middle Initial & Last Name & Degree
Yasser S Mostafa, MD
Phone
01010509735
Ext
002
Email
ysm03@fayoum.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24564777
Citation
Chvojka J, Matejovic M. [International guidelines for management of severe sepsis and septic shock 2012 - comment]. Vnitr Lek. 2014 Jan;60(1):59-67. Czech.
Results Reference
background
PubMed Identifier
27324241
Citation
Haddam M, Zieleskiewicz L, Perbet S, Baldovini A, Guervilly C, Arbelot C, Noel A, Vigne C, Hammad E, Antonini F, Lehingue S, Peytel E, Lu Q, Bouhemad B, Golmard JL, Langeron O, Martin C, Muller L, Rouby JJ, Constantin JM, Papazian L, Leone M; CAR'Echo Collaborative Network; AzuRea Collaborative Network. Lung ultrasonography for assessment of oxygenation response to prone position ventilation in ARDS. Intensive Care Med. 2016 Oct;42(10):1546-1556. doi: 10.1007/s00134-016-4411-7. Epub 2016 Jun 20.
Results Reference
background

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Lung Ultrasound Score and Inferior Vena Cava Diameter Compared to Pulse Pressure Variation

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