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

Sponsor
Medical University of Gdansk (Other)
Overall Status
Recruiting
CT.gov ID
NCT05554783
Collaborator
(none)
50
Enrollment
1
Location
30.8
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Analysis of Passive Leg Raise Test on Blood Pressure in Critically Ill Patients.
Actual Study Start Date :
Jun 6, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Correlation of SVV with increase in blood pressure [10 minutes]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Gdańsk - Department of Anesthesiology and Intensive Care Gdańsk Pomorskie Poland

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT05554783
Other Study ID Numbers:
  • PLRonBP
First Posted:
Sep 26, 2022
Last Update Posted:
Sep 26, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hypovolemia

Study Results

No Results Posted as of Sep 26, 2022