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the Impact of Manual or Mechanical Ways to Perform PLR on the Accuracy of Evaluation of Fluid Responsiveness

the Impact of Manual or Mechanical Ways to Perform Passive Leg Raising on the Accuracy of Evaluation of Fluid Responsiveness

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06285331
Acronym
PLR
Enrollment
60
Registered
2024-02-29
Start date
2023-11-06
Completion date
2025-12-31
Last updated
2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulatory Failure

Keywords

Fluid Responsiveness, Passive Leg Raising

Brief summary

Our goal was to study the impact of different ways to perform passive leg raising (PLR) on the accuracy of evaluation of fluid responsiveness.

Detailed description

Patients who have shock of all kinds of reasons usually need to be transferred to the Intensive Care Unit(ICU) for monitoring and treatment due to unstable vital signs and high fatal risks. The cardiac function of these patients requires special attention. Fluid responsiveness is a comprehensive reflection of preload and cardiac function, which provides guidance on how to conduct fluid replacement therapy. When patients have fluid responsiveness, it means that after fluid resuscitation therapy, the patients' cardiac output will increase and tissue perfusion will improve, bringing benefits to patients themselves. Therefore, it is of vital significance to evaluate the presence of fluid responsiveness in patients before fluid therapy in clinical practice. Passive leg raising(PLR) is a commonly used method in clinical practice to evaluate patients' fluid responsiveness. But its accuracy is affected by the way the leg lifting is performed. This project is aimed to explore the impact of different ways to perform passive leg raising on the accuracy of evaluation of fluid responsiveness.

Interventions

DEVICEAutomatic Bed

The automatic bed is controlled by a screen and allows clinicians to perform passive leg raising on patients without touching them physically.

DEVICEManual

The clinicians will perform passive leg raising on patients by touching their legs physically.

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* (1) patients who have signs of tissue hypo-perfusion (increasing lactate levels, in need of vasopressor agents to maintain blood pressure, oliguria, and weak consciousness), and need to evaluate their fluid responsiveness; (2) patients who have received Pulse indicator Continuous Cardiac Output (PiCCO) monitoring ; (3) patients who are transferred into the intensive care department.

Exclusion criteria

* (1) Age \< 18 years old, or \> 75 years old (2) pregnancy or lactation; (3) refusal to sign the informed consent form for enrollment; (4) patients who are clearly unable to perform passive leg raising (PLR) (intra-abdominal pressure ≥16cmH2O, high risk of lower limb venous thrombosis, intracranial hypertension, and recent undergone abdominal or pelvic surgery); (5) patients with the contraindications of fluid resuscitation therapy ( pulmonary edema, intracranial hypertension and so on); (6) patients clinical doctors assessed as unsuitable for PLR.

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of fluid responsiveness evaluationImmediately after procedureIt is the results of accuracy of evaluation of patients' fluid responsiveness by performing PLR by different ways. The accuracy is evaluated by comparing the results of PLR and fluid challenge test. The cardio output of patients is obtained by Pulse indicator Continuous Cardiac Output (PiCCO). The results of PLR are considered accurate if the results of the patient's volume responsiveness measured by different methods of PLR are consistent with the results obtained by the fluid challenge test.

Secondary

MeasureTime frameDescription
Mortality90daysThe mortality of patients within 90 days after PLR was performed.

Countries

China

Contacts

Primary ContactJingyuan Xu, M.D.
xujingyuanmail@163.com8602583262550

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026