Ultrasound Markers of Systemic Inflammation

Completed

• Conditions: Swelling; Hand; Vasomotor Arterial Disorder; Inflammation Process; Endothelial Dysfunction; Vascular Dilation
• Interventions: Diagnostic Test: Ultrasound measurement

• Registration Number: NCT05798182
• Lead Sponsor: Osijek University Hospital

Brief Summary

The aim of this study was to measure whether the flow rate through the brachial artery and inflammatory markers were associated with the development of tissue edema in the surgical intensive care unit patients.

Detailed Description

The study was performed using a ultrasound machine with linear probe settings at 50 mm depth and 40 decibel \[dB\] gain that did not change during the study. The probe was placed on vascular ultrasound measurement. The diameter of the brachial artery in the middle of the upper arm and the flow rate through the artery was measured on postoperative days 1 and 2. The presence of the edema was measured above the 3rd metacarpal bone as the distance from the skin surface to the periosteum. An average of three assessments was shown. Patient's age, body mass index (BMI), type of admission, white blood cells (WBC), C-reactive protein (CRP), and procalcitonin (PCT) were also registered.

Study Timeline

• Study Start: 2020-12-01
• Status Verified: 2021-05
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2023-03-22
• Last Update Submitted: 2023-03-22
• Study First Posted: 2023-04-04
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Adults over 18 years of age
• Postoperative surgical patients
• Signed informed consent

Exclusion Criteria

• Refusal to give informed consent
• A previous thromboembolic event of the brachial artery
• Acute infection of the upper extremity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU patients	Ultrasound measurement	Adult patients admitted to the ICU.

Primary Outcome Measures

Name	Time	Method
Distance from skin to third metacarpal bone - 2	day 2 after admission is between 24 and 48 hours after admission.	measurement of a distance from the skin to third metacarpal bone (cm) on day 2 after admission.
C-reactive protein - 2	day 2 after admission is between 24 and 48 hours after admission.	Blood sample analysis for C-reactive protein (CRP \[mg/L\]) concentration on day 2 after admission.
Procalcitonin - 1	within 4 hours of admission.	blood sample analysis for Procalcitonin concentration (PCT \[ug/L\]) at admission.
Brachial artery flow velocity - 1	within 4 hours of admission to ICU.	measurement of a brachial artery flow velocity \[cm/s\] at admission.
White blood cell count - 2	day 2 after admission is between 24 and 48 hours after admission.	blood sample analysis for white blood cell count (WBC \[10\^9/L\]) on day 2 after admission.
Procalcitonin - 2	Day 2 after admission is between 24 and 48 hours after admission.	Blood sample analysis for Procalcitonin concentration (PCT \[ug/L\]) on day 2 after admission.
Diameter of brachial artery - 1	within 4 hours of admission.	Measurement of a brachial artery diameter \[cm\] at admission. Admission day is considered as day 1.
Diameter of brachial artery - 2	day 2 after admission is between 24 and 48 hours after admission.	measurement of a brachial artery diameter \[cm\] on day 2 after admission.
Brachial artery flow velocity - 2	day 2 after admission is between 24 and 48 hours after admission.	measurement of a brachial artery flow velocity \[cm/s\] on day 2 after admission. Day 2 is Measurement of a brachial artery flow velocity \[cm/s\] between 24 and 48 h after ICU admission.
Distance from skin to third metacarpal bone -1	within 4 hours of admission.	measurement of a distance from the skin to third metacarpal bone (cm) at admission.
C-reactive protein - 1	within 4 hours of admission.	blood sample analysis for C-reactive protein (CRP \[mg/L\]) concentration at admission.
White blood cell count - 1	within 4 hours of admission.	blood sample analysis for white blood cell count (WBC \[10\^9/L\]) at admission.

Trial Locations

Locations (1)

Slavica Kvolik; 🇭🇷 Osijek, Croatia