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

NCT04732481 | Completed

• 1 other identifier: QP-RIPH3-001
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Organ Failure, Multiple

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• cut-off value for positivity of the test

  90sec

Study Arms (2)

interventional group

passive leg lift test

Procedure: passive leg lift test

control group

no intervention (SOC)

Interventions

passive leg lift test PROCEDURE

passive leg lift test

interventional group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Cornouaille: lead

Study Sites (1)

Ch Cornouaille

Quimper, Finistere, 29000, France

Location

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 1, 2021
• Study Start: April 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 9, 2022

Record last verified: 2022-03

Locations

FR (1)