Efficacy of Lung and Inferior Vena Cava Sonography for Fluid Optimization

Not Applicable

• Conditions: Traumatic Brain Injury
• Interventions: Procedure: Standard care (control group); Procedure: US-guided fluid management (active group); Other: Standard ICU Care

• Registration Number: NCT05400343
• Lead Sponsor: Mansoura University

Brief Summary

Traumatic brain injury (TBI) is a leading cause of death and disability in trauma patients. As the primary injury cannot be reversed, management strategies must focus on preventing secondary injury by avoiding hypotension and hypoxia and maintaining appropriate cerebral perfusion pressure (CPP), which is a surrogate for cerebral blood flow (CBF). The goal should be euvolemia and avoidance of hypotension. The assessment of a patient's body fluid status is a challenging task for modern clinicians.

The use of Ultrasonography to assess body fluids has numerous advantages. The concept of using lung ultrasound for monitoring the patient is one of the major innovations that emerged from recent studies. Pulmonary congestion may be semiquantified using lung ultrasound and deciding how the patient tolerates fluid. Inferior vena cava (IVC) sonography and point-of-care ultrasound (POCUS) has become widely used as a tool to help clinicians prescribe fluid therapy. Common POCUS applications that serve as guides to fluid administration rely on assessments of the inferior vena cava to estimate preload and lung ultrasound to identify the early presence of extravascular lung water and avoid fluid over resuscitation In this study we will use the measurements of both lung and IVC together to guide fluid dosage in critically ill patients with TBI. We will also use ONSD as a mirror for intra-cranial pressure (ICP).

Detailed Description

The aim of this study is to detect the effectiveness of using IVC and lung ultrasound as bedside tools to ensure euvolemia in patients with traumatic brain injuries

Positive fluid balances have been associated with (angiographic) vasospasm, longer hospital length of stay and poor functional outcomes The assessment of a patient's body fluid status is a challenging task for modern clinicians. Currently, the most accurate method to guide fluid administration decisions uses "dynamic" measures that estimate the change in cardiac output that would occur in response to a fluid bolus. Unfortunately, their use remains limited due to required technical expertise, costly equipment, or applicability in only a subset of patients. Alternatively, point-of-care ultrasound (POCUS) has become widely used as a tool to help clinicians prescribe fluid therapy.

International recommendations suggest that the inferior vena cava (IVC) can be assessed to estimate the pressure in the right atrium of non-ventilated patients because of its collapsibility during inspiration. An IVC diameter of \< 21mm with collapsibility of \> 50% during inspiration suggests normal right atrium pressure (between 0 and 5 mmHg), whereas a diameter of \> 21mm with collapsibility of \< 50% suggests high pressure (between 10 and 20mmHg). The dynamic method of IVC evaluation, based on the variation in its diameter with respiration, enables the assessment of the potential benefit of fluid administration as a function of IVC compliance.

Ultrasonography of optic nerve sheath diameter (ONSD) in TBI patients has been shown to correlate with increased ICP and systemic reviews have supported this observation.

In this study, we will use the measurements of both lung and IVC together to guide fluid dosage in critically ill patients with TBI. We will also use ONSD as a mirror for ICP

The study investigates the effect of using bedside sonography in fluid assessment in a critically ill patient

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Study First Posted: 2022-06-01
• Last Update Posted: 2022-06-01
• Study Start: 2022-06-15
• Primary Completion: 2023-04
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• BMI less than 35 kg/m2
• Diagnosed with traumatic brain injury
• Glasgow coma score ≥ 4

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Exclusion Criteria

• Inability to get consent
• Presence of Increased intra-abdominal pressure,
• Presence of acute cor pulmonale
• Presence of severe right ventricular dysfunction.
• Pregnancy
• Patients with known pulmonary conditions that interfere with the interpretation of lung ultrasound like pneumectomy; pulmonary fibrosis; persistent pleural effusion
• Stage 5 chronic kidney disease
• indication for emergency renal replacement therapy (RRT)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care (control group)	Standard care (control group)	fluid therapy will be guided by conventional ICU policies to maintain an adequate intravascular volume and good urine output
US-guided fluid management (active group)	US-guided fluid management (active group)	Fluid therapy will be guided by measurements of lung and IVC sonography
Standard care (control group)	Standard ICU Care	fluid therapy will be guided by conventional ICU policies to maintain an adequate intravascular volume and good urine output
US-guided fluid management (active group)	Standard ICU Care	Fluid therapy will be guided by measurements of lung and IVC sonography

Primary Outcome Measures

Name	Time	Method
Cumulative Fluid balance	10 days or until ICU discharge which comes first.	The difference between patient fluid intake and patient fluid output is recorded every 24 h then the cumulative balance is recorded

Secondary Outcome Measures

Name	Time	Method
ONSD as mirror for intracranial pressure.	every other day for 10 days or until ICU discharge which comes first	Ultrasonic examination will be performed by an experienced investigator with a 11-3 MHz linear transducer. The patients will be examined in a supine position with the head elevated at 20-30° ONSD was defined as the distance between the external borders of the hyperechoic area 3 mm posterior to the point where the optic nerve entered the globe, using an electronic caliper along the axis perpendicular to the retina. . To minimize intraobserver variability, each measurement was performed three times and the mean value was derived
Urine output	10 days or until ICU discharge which comes first	patient urine output per ml is collected and recorded every 6 hours and total daily urine output is recorded
Frequency of hypotension	every other day for 10 days or until ICU discharge which comes first	hypotension is defined as systolic blood pressure less than 90 mmHg, or diastolic blood pressure less than 50 mmHg or both or more than 20 % decline in basal blood pressure for more than 5 minutes.
Duration of hypotension	10 days or until ICU discharge which comes first	every other day for 10 days or until ICU discharge which comes first
Serum creatinine	10 days or until ICU discharge which comes first	daily serum creatinine in mg /dl is ordered and recorded
Incidence of pulmonary edema	10 days or until ICU discharge which comes first	Diagnosis of the patient with pulmonary edema by (x ray, CT, pulse oximetry, other methods) is recorded
Length of mechanical ventilation	10 days or until ICU discharge which comes first	Duration of mechanical ventilation in days is record
Mortality at 10 days	mortality at day 10

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansourah, DK, Egypt