Clinical trial NCT06921642: Simplified Inferior Vena Cava Collapsiblity
Official title: "Performance of a Simplified Inferior Vena Cava Collapsibility Methodology to Predict Preload Responsiveness (PR) in Spontaneously Breathing and Critically Ill Patients"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Circulatory Failure
Keywords: Fluid therapy
preload responsiveness
spontaneously breathing
critically ill patient
standardized inspiratory maneuver
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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)

Primary outcomes:
measure: Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness
timeFrame: 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:
measure: Performance of inferior vena cava collapsibility index during a deep breath (without monitoring of inspiratory strength) to predict preload responsiveness
timeFrame: 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.
measure: Performance of simplified inferior vena cava collapsibility index to predict preload responsiveness during different time of cardiac cycle
timeFrame: 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.
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital
Study officials:
References: