Simplified Inferior Vena Cava Collapsiblity

NCT ID: NCT06921642

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-06
• Study Completion Date: 2024-06-07

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.

Detailed 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.

Conditions

Circulatory Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Echocardiography images

Intervention Type: DEVICE

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

Interventions

Echocardiography images

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

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lille University Hospital

Lille, , France

Countries

France

Other Identifiers

2022_0324

Identifier Type: -

Identifier Source: org_study_id