NCT05554783

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

2.6 years

First QC Date

April 21, 2022

Last Update Submit

September 23, 2022

Conditions

ShockHypovolemiaHemodynamic Instability

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Trendelenburg positionDIAGNOSTIC_TEST

Positioning the patient with head 15 degrees down

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • hemodynamic instability
  • mechanical ventilation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Gdańsk - Department of Anesthesiology and Intensive Care

Gdansk, Pomeranian Voivodeship, Poland

RECRUITING

MeSH Terms

Conditions

ShockHypovolemia

Interventions

Head-Down Tilt

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jan Stefaniak, M.D.

    Medical University of Gdańsk, Department of Anesthesiology and Intensive Therapy

    PRINCIPAL INVESTIGATOR

  • Radosław Owczuk, M.D., Ph.D.

    Medical University of Gdańsk, Department of Anesthesiology and Intensive Therapy

    STUDY DIRECTOR

Central Study Contacts

Jan Stefaniak, M.D.

CONTACT

+48583493270klanest@gumed.edu.pl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

September 26, 2022

Study Start

June 6, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 26, 2022

Record last verified: 2022-09

Locations

PL(1)