Simplified Inferior Vena Cava Collapsiblity

Completed

• Conditions: Circulatory Failure

• Registration Number: NCT06921642
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2023-06-06
• Primary Completion: 2024-06-07
• Study Completion: 2024-06-07
• Study First Submitted: 2025-03-07
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of simplified inferior vena cava collapsibility index 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.	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 Outcome Measures

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

Trial Locations

Locations (1)

Lille University Hospital; 🇫🇷 Lille, France