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Completed

NCT Number: NCT06921642

Simplified Inferior Vena Cava Collapsiblity

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.

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Key information

Conditions

Circulatory Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Shock

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lille University Hospital

Lille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Echocardiography images

Device

Addition of a recording loop during routine ultrasound, during which the patient is in simplified standardized ventilation

Primary outcomes

  1. Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness

    Time frame: The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.

    the area under the ROC curve of the parameter of simplification of inspiratory effort in relation to the positive hemodynamic response positive haemodynamic response (cardiac preload-dependence) to a passive leg raising manoeuvre

Secondary outcomes

  1. Performance of inferior vena cava collapsibility index during a deep breath (without monitoring of inspiratory strength) to predict preload responsiveness

    Time frame: The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.

    comparison of the areas under the ROC curve for the parameter simplifying inspiratory effort during tele-diastole or tele-cardiac systole

  2. Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness during different time of cardiac cycle

    Time frame: The echocardiographic loops used to measure cVCI and preload responsiveness will be performed on the day of inclusion refered as baseline. Precise measurements will be conducted offline within the 6 months after the end of the inclusions.

    the area under the ROC curve of the parameter of simplification of inspiratory effort in relation to the positive hemodynamic response positive haemodynamic response (cardiac preload-dependence) to a passive leg raising manoeuvre

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

"Performance of a Simplified Inferior Vena Cava Collapsibility Methodology to Predict Preload Responsiveness (PR) in Spontaneously Breathing and Critically Ill Patients"

Acronym: CVCISIMPLIFIEE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

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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