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

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

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

Study Overview

• Status: Recruiting
• Conditions: Circulatory Failure
• Intervention / Treatment: Device: Automatic Bed; Device: Manual

Detailed Description

Patients who have undergone cardiac thoracotomy surgery usually need to be transferred to the Intensive Care Unit(ICU) for monitoring and treatment due to unstable vital signs and high perioperative 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingyuan Xu, M.D.; Phone Number: 8602583262550; Email: xujingyuanmail@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Zhongda Hospital Southeast University
      • Contact: Jingyuan Xu, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1) patients who appear to be of volume deficiency during postoperative period (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 undergone cardiac thoracotomy surgery; (3) patients who are transferred into the intensive care department for monitoring after surgery.

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 using ICON Cardiac Monitor ( patients with a rate-responsive implantable cardiac pacemaker which uses electrical impedance measurements to obtain minute ventilation, patients currently undergoing external defibrillation therapy, patients using high-frequency oscillation ventilation, patients with artificial heart or heart assist device like IABP or VA-ECMO); (6) patients with the contraindications of fluid resuscitation therapy ( pulmonary edema, intracranial hypertension and so on); (7) patients who underwent partial aortic resection with artificial vessel replacement surgery ( such as after aortic aneurysm or aortic dissection vessel replacement surgery); (8) patients clinical doctors assessed as unsuitable for PLR.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Automatic Bed; PLR will be performed by adjusting the automatic bed the patients stay on.	Device: Automatic Bed; The automatic bed is controlled by a screen and allows clinicians to perform passive leg raising on patients without touching them physically.
Placebo Comparator: Manual; PLR will be performed by the investigators by their hands.	Device: Manual; The clinicians will perform passive leg raising on patients by touching their legs physically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of fluid responsiveness evaluation	It 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 noninvasive cardiac output monitoring device. 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.	Immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	The mortality of patients within 90 days after PLR was performed.	90days

Collaborators and Investigators

• Sponsor: Southeast University, China
• Investigators: Principal Investigator: Jingyuan Xu, M.D., Zhongda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Fluid Responsiveness; Passive Leg Raising
• Additional Relevant MeSH Terms: Pathologic Processes; Shock
• Other Study ID Numbers: 2023ZDSYLL483-P01

Drug and device information, study documents

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