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

Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05554783
• Other study ID #: PLRonBP
• Status: Recruiting
• Start date: June 6, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Medical University of Gdansk
• Contact: Jan Stefaniak, M.D.
• Phone: +48583493270
• Email: klanest[@]gumed.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodynamic Instability
• Hypovolemia
• Shock

Intervention

Diagnostic Test:
• Trendelenburg position
Positioning the patient with head 15 degrees down

Locations

Country	Name	City	State
Poland	Medical University of Gdansk - Department of Anesthesiology and Intensive Care	Gdansk	Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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