Clinical trial
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
Name
D 310
Description
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.
Trial arms
Trial start
2022-09-13
Estimated PCD
2024-05-20
Trial end
2024-06-20
Status
Recruiting
Treatment
normal Saline
normal saline cyrstalloids infusion with rate of 4ml/kg /h for 3 hours
Arms:
Scanning group
Other names:
Fluid challenge test
lung ultrasound
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
Arms:
Scanning group
inferior vena cava measurements
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.
Arms:
Scanning group
passive leg raising test (PLRT)
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).
Arms:
Scanning group
pulse pressure variation
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.
Arms:
Scanning group
Size
150
Primary endpoint
The sensitivity of lung ultrasound in predicting fluid responsiveness.
After 5 minutes of admission
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2024-04-09
1 organization
Organization
Fayoum University Hospital