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Simplified Inferior Vena Cava Collapsiblity (CVCISIMPLIFIEE)

U

University Hospital, Lille

Status

Completed

Conditions

Circulatory Failure

Treatments

Device: Echocardiography images

Study type

Observational

Funder types

Other

Identifiers

NCT06921642
2022_0324

Details and patient eligibility

About

Fluid administration is a cornerstone therapy in critically ill patient. Fluid restriction or overload can therefore change patient's outcome and mortality. Close monitoring of PR (capacity of increase the cardiac output after fluid therapy) is recommended by experts' guidelines. Few bedside simple tests are available to predict PR in spontaneously breathing patients.

A team of investigators from Lille (Roger Salengro hospital) have already showed that inferior vena cava collapsibility (cVCI) accuracy of prediction of PR is excellent in standardized sponteanous breathing patient. However, the standardized inspiration maneuver remains challenging because requiring specific and non-widely available equipment.

Full description

The primary objective of this study is to confirmed the excellent accuracy of cVCI to predict PR when standardized inspiratory maneuver is simplified.

The secondary objective is to test cVCIs in different period of cardiac cycle guided by electrocardiogram.

After receiving a loyal information patients will give their non-objection. During systematic echocardiography, patients will have to breathe in different conditions in order to homogenize their inspiratory effort. This maneuver will be repeated three times.

Enrollment

74 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient requiring an evaluation of PR by echocardiography for
  • Presence of at least one clinical sign of acute circulatory failure (Mean Arterial Pressure < 65 mmHg, mottling, tachycardia with Heart Rate > 90 bpm, capillary refill time > 3 sec, oliguria (urine output < 0,5 mL/kg/h over 1 hour or more))
  • Noradrenaline administration
  • Age > 18 years old
  • Spontaneous breathing patient requiring oxygen administration without mechanical assistance

Exclusion criteria

  • Intolerance of inspiratory maneuver defined by:

    • Clinical sign of acute respiratory failure
    • Active abdominal expiration
  • Hemodynamic response of passive leg raising not evaluable:

    • Intracranial hypertension
    • Impaired transthoracic or abdominal echogenicity
    • High grade aortic insufficiency
    • Pregnancy
    • Abdominal compartment syndrome
    • Lower limb amputation
  • Urgent hemodynamic therapy within half an hour

  • Modification of hemodynamic support (fluid therapy or modification of catecholamine dose)

Trial design

74 participants in 1 patient group

Spontaneous breathing patient responding to the inclusion criteria
Description:
During a transthoracic echocardiography, the doctor will realize * loops on inferior vena cava in different breathing conditions : * non standardized spontaneous breathing * simplified standardized spontaneous breathing using a TRIFLOW III spirometer device. Standardized inspiration is defined by the complete ascension of the first of the three device ball. * deep spontaneous inspiration defined by profound inspiration during \< 3 seconds without calibration of inspiratory strengh * measure of subaortic velocity time integral (Vti) during a passive leg raising. Inferior vena cava collapsibility index will be calculated using inferior vena cava diameter, at 4 cm from right atrium abutment, using the following equation: (Diameter max - diameter min)/ diameter max. PR will be defined by 10% increase of Vti during passive leg raising.
Treatment:
Device: Echocardiography images

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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