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OpenTrials
Completed

NCT Number: NCT04732481

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ch Cornouaille

Quimper, Finistere, 29000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

passive leg lift test

Procedure

passive leg lift test

Primary outcomes

  1. response to filling

    Time frame: 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 outcomes

  1. cut-off value for positivity of the test

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Cornouaille

Other

Registry information

Official study title

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

Acronym: CAROT

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 1, 2021
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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