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

NCT06285331 | Recruiting

• 1 other identifier: 2023ZDSYLL483-P01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Circulatory Failure

Keywords

Fluid Responsiveness; Passive Leg Raising

Outcome Measures

Primary Outcomes (1)

• 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 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.

  Immediately after procedure

Secondary Outcomes (1)

• Mortality

  90days

Study Arms (2)

Automatic Bed

ACTIVE COMPARATOR

PLR will be performed by adjusting the automatic bed the patients stay on.

Device: Automatic Bed

Manual

PLACEBO COMPARATOR

PLR will be performed by the investigators by their hands.

Device: Manual

Interventions

Automatic Bed DEVICE

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

Automatic Bed

Manual DEVICE

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

Manual

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (1)

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jingyuan Xu, M.D.

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyuan Xu, M.D.

CONTACT

8602583262550; xujingyuanmail@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zhongda Hospital

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 29, 2024
• Study Start: November 6, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

CN (1)