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

Organ Failure, Multiple Clinical Trial

— CAROT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04732481
• Other study ID #: QP-RIPH3-001
• Status: Completed
• Start date: April 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: March 2022
• Source: Centre Hospitalier de Cornouaille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Organ Failure
• Organ Failure, Multiple

Intervention

Procedure:
• passive leg lift test
passive leg lift test

Locations

Country	Name	City	State
France	Ch Cornouaille	Quimper	Finistere

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Cornouaille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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