Evaluation of Corrected Carotid Flow Time Variations During Passive Leg Lift to Predict Response to Filling. (CAROT)

Evaluation of Corrected Carotid Flow Time Variations During Passive Leg Lift to Predict Response to Filling

Patients hospitalized in intensive care often require intravenous administration of fluid in order to optimize the functioning of the heart and thus ensure perfusion of vital organs such as the kidneys, the brain or the digestive tract. However, it is necessary to find the right balance in fluid intake because it has been shown that excessive administration has a negative impact on patient survival, the length of their stay in intensive care or the duration of invasive mechanical ventilation.The passive leg lifting maneuver is regularly used to determine which patients should be infused with these large volumes (the patient's chest is placed in a horizontal position and the legs are elevated at 30 ° by tilting the bed for 2 minutes ). To be interpreted, this maneuver requires the presence of invasive devices (bloody arterial pressure catheter, PICCO monitor) or an operator experienced in cardiac ultrasound.Our study aims to evaluate an easy-to-use, non-invasive tool widely available in intensive care and emergency departments (carotid vascular doppler ultrasound) to assess the response to a passive leg lifting maneuver. . The measurements are taken before and after a passive leg lifting maneuver and then before and after a filling decided before inclusion by the doctor responsible for the patient.

Study Overview

• Status: Completed
• Conditions: Organ Failure, Multiple
• Intervention / Treatment: Procedure: passive leg lift test

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• France
  • Finistere
    • Quimper, Finistere, France, 29000
      • Ch Cornouaille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

During their ICU admission for organ failure or multiple organ failure, patients frequently receive volume expansion to increase cardiac output.

Description

Inclusion Criteria:

• equipped with a PICCO2® continuous cardiac output monitoring device
• for which the practitioner in charge of the patient decides to administer a volume expansion

Exclusion Criteria:

• patients whose rhythm is non-sinus
• who have expressed their refusal to participate in the protocol
• contraindicated to passive leg lifting maneuvers (deep vein thrombosis, HTIC, BMI> 40 or> 14, spinal instability)
• pregnant women and patients clinically suspected of abdominal compartment syndrome

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
interventional group; passive leg lift test	Procedure: passive leg lift test; passive leg lift test
control group; no intervention (SOC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response to filling	Collection of the diagnosis of response to filling after volume expansion of 500mL of Isotonic Salted Serum and evaluation of the variation in TFCc during passive leg lifting between the two groups	90sec

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cut-off value for positivity of the test	The secondary objective of this work is to determine the best positivity threshold value of the test studied as well as its sensitivity and specificity for the chosen value.	90sec

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Cornouaille

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 27, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Shock; Multiple Organ Failure
• Other Study ID Numbers: QP-RIPH3-001

Drug and device information, study documents

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