Analysis of Passive Leg Raise Test on Blood Pressure in Critically Ill Patients.

Positioning intensive care patients in Trendelenburg position to identify fluid responsiveness assessed by PiCCO device.

Study Overview

• Status: Recruiting
• Conditions: Shock; Hypovolemia; Hemodynamic Instability
• Intervention / Treatment: Diagnostic test: Trendelenburg position

Detailed Description

It is a prospective observational study. Patients admitted to Intensive Care Unit of University Clinical Centre of Gdańsk, receiving advanced hemodynamic monitoring with PiCCO method will be enrolled. After blood pressure measurement, PiCCO will be calibrated with transpulmonary thermodilution with 10 - 20 ml of cold saline. Readings will be noted. The patient will be positioned in Trendelenburg position with it's head 15 degrees down. The increase of blood pressure after positioning in relation to the values obtained before the trial will be correlated to the parameters that asses patent's volaemia. After 5 minutes patient will be back to supine position and hemodynamic parameters will be recorded for another 5 minute.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Jan Stefaniak, M.D.; Phone Number: +48583493270; Email: klanest@gumed.edu.pl

Study Locations

• Poland
  • Pomorskie
    • Gdańsk, Pomorskie, Poland
      • Recruiting
      • Medical University of Gdańsk - Department of Anesthesiology and Intensive Care
      • Contact: Jan Stefaniak, M.D.; Phone Number: +48583493270; Email: klanest@gumed.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to Intensive Care Unit of University Clinical Centre in Gdańsk

Description

Inclusion Criteria:

• hemodynamic instability
• mechanical ventilation

Exclusion Criteria:

• increased intracranial pressure
• increased intraabdominal pressure
• lower limbs sequential compression system
• agitation
• patients exposed to pain stimulus before the test
• aortic aneurysm
• left to right cardiac shunt
• severe valvular insufficiency

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of SVV with increase in blood pressure	Stroke volume variation (SVV) is a validated parameter that assess fluid responsiveness. In patients in whom SVV value is higher, theoretically Trendelenburg position will increase blood pressure in greater degree, than in patients in whom SVV is lower. We want to identify whether such correlation exist.	10 minutes

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Principal Investigator: Jan Stefaniak, M.D., Medical University of Gdańsk, Department of Anesthesiology and Intensive Therapy; Study Director: Radosław Owczuk, M.D., Ph.D., Medical University of Gdańsk, Department of Anesthesiology and Intensive Therapy

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: PLRonBP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No