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

NCT05980494 | Completed

• 1 other identifier: D 310
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Critical Illness

Keywords

lung utlrasound; pulse pressure variation; inferior vena cava; fluid responsiveness

Outcome Measures

Primary Outcomes (1)

• The sensitivity of lung ultrasound in predicting fluid responsiveness.

  \<0.8: non-sensitive, \>0.8: sensitive

  After 5 minutes of admission

Secondary Outcomes (13)

• lung ultrasound B lines score

  after 5 minutes of admission

• Inferior vena cava distensibility index.

  after 10 minutes of admission

• pulse pressure variation

  15 minutes after admission

• central venous pressure

  after 20 minutes of admission

• heart rate

  5 minutes after admission

Other Outcomes (4)

• weight

  5 minutes before admission

• height

  5 minutes before admission

• body mass index

  5 minutes before admission

Study Arms (1)

Scanning group

EXPERIMENTAL

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

Drug: normal Saline; Device: lung ultrasound; Device: inferior vena cava measurements; Diagnostic Test: passive leg raising test (PLRT); Device: pulse pressure variation

Interventions

normal Saline DRUG

normal saline cyrstalloids infusion with rate of 4ml/kg /h for 3 hours

Also known as: Fluid challenge test

Scanning group

lung ultrasound DEVICE

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

Scanning group

inferior vena cava measurements DEVICE

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.

Scanning group

passive leg raising test (PLRT) DIAGNOSTIC_TEST

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).

Scanning group

pulse pressure variation DEVICE

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.

Scanning group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, 63514, Egypt

Location

Related Publications (2)

• 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.

  PMID: 24564777 BACKGROUND

• 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.

  PMID: 27324241 BACKGROUND

MeSH Terms

Conditions

Sepsis; Critical Illness

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• omar S farghaly, MD

  lecturer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: September 13, 2022
• Primary Completion: May 20, 2024
• Study Completion: June 20, 2024
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)