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

Sponsor
Centre Hospitalier de Cornouaille (Other)
Overall Status
Completed
CT.gov ID
NCT04732481
Collaborator
(none)
21
1
5
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: passive leg lift test

Study Design

Study Type:
Observational
Actual Enrollment :
21 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Corrected Carotid Flow Time Variations During Passive Leg Lift to Predict Response to Filling
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Jun 1, 2021
Actual Study Completion Date :
Sep 1, 2021

Arms and Interventions

Arm Intervention/Treatment
interventional group

passive leg lift test

Procedure: passive leg lift test
passive leg lift test

control group

no intervention (SOC)

Outcome Measures

Primary Outcome Measures

  1. response to filling [90sec]

    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

Secondary Outcome Measures

  1. cut-off value for positivity of the test [90sec]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ch Cornouaille Quimper Finistere France 29000

Sponsors and Collaborators

  • Centre Hospitalier de Cornouaille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier de Cornouaille
ClinicalTrials.gov Identifier:
NCT04732481
Other Study ID Numbers:
  • QP-RIPH3-001
First Posted:
Feb 1, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022