Simplified Inferior Vena Cava Collapsiblity

NCT06921642 | Completed

• 1 other identifier: 2022_0324
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Circulatory Failure

Keywords

Fluid therapy; preload responsiveness; spontaneously breathing; critically ill patient; standardized inspiratory maneuver

Outcome Measures

Primary Outcomes (1)

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

  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

  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.

Secondary Outcomes (2)

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

  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.

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

  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.

Study Arms (1)

Spontaneous breathing patient responding to the inclusion criteria

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.

Device: Echocardiography images

Interventions

Echocardiography images DEVICE

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

Spontaneous breathing patient responding to the inclusion criteria

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patient hospitalized in an intensive care unit of the Medecine intensive center of Lille who respond to the inclusion criteria may be included in this trial

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Lille University Hospital

Lille, France

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: April 10, 2025
• Study Start: June 6, 2023
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: April 10, 2025

Record last verified: 2025-04

Locations

FR (1)