Pronostic Value of Fluid Responsiveness Evaluated by Inferior Vena Cava Collapsibility Index in Patients Admitted in ICU With Acute Respiratory Failure (PRIVACY)

Pronostic Value of Fluid Responsiveness, Evaluated by Inferior Vena Cava Collapsibility Index, in Patients Admitted in ICU With Acute Respiratory Failure '' PRIVACY Study''

Acute respiratory failure represents a frequent cause of admission to intensive care units (ICUs). In the absence of tailored interventions, it poses an imminent threat to patients' lives. Most patients admitted in ICU undergo fluid expansion to enhance oxygen delivery and preserve cellular function.

This practice is grounded in the concept of " preload responsiveness ". However, the accrual of positive fluid balance resulting from fluid administration is now acknowledged as an autonomous risk factor for mortality.

Consequently, preload unresponsiveness assumes a pathological character, potentially indicative of fluid overload or right ventricular dysfunction, both deleterious conditions linked to unfavorable outcomes.

Maintaining patients in a preload-responsive state may be interesting to limit fluid expansion and the need of invasive mechanical ventilation.

The objective of this prospective observational study is to evaluate the prognostic significance of preload responsiveness in patients admitted to the ICU with hypoxemic, non-hypercapnic respiratory failure.

• Main objective: To evaluate the association between fluid responsiveness, assessed by the inferior vena cava collapsibility index (cIVC) with trans-thoracic echocardiography within the initial 48 hours post-ICU admission, and mortality or the need for invasive mechanical ventilation by day 28 in patients admitted to the ICU for hypoxemic, non-hypercapnic acute respiratory failure.
• Secondary objectives: To evaluate the association between fluid responsiveness and mortality at day 28 and day 90, the need of invasive mechanical ventilation, and the number of days free from organ support (vasopressors, mechanical ventilation and renal replacement therapy) by day 28.

Upon receipt of both oral and written information, patients will provide non-objection to participate in the study. This prospective single-center study has obtained approval from the Regional Ethics Committee of Ile de France III approval (No. 2022-A02813-40).

Study Overview

• Status: Completed
• Conditions: Hypoxemic Without Hypercapnia Acute Respiratory Failure

Detailed Description

Video loops of the inferior vena cava (IVC) will be recorded during a transthoracic echocardiography performed for diagnostic purpose. This method is routinely employed in our ICU to assess preload responsiveness in spontaneously breathing patients admitted for acute respiratory failure. For study purposes, IVC diameters will be measured remotely on anonymized recordings by operators blinded to patients' outcomes. The cIVC will be calculated at 4 cm from the IVC-right atrium junction, using the following equation: (Maximum expiratory diameter - inspiratory diameter)/ Maximum expiratory diameter.

According to prior research conducted by our group (Caplan et al., Ann Intensive Care 2020), a cIVC ≥44% will be utilized to diagnose preload responsiveness.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Lille
    • Lille, Lille, France, 59037
      • Hôpital Roger Salengro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This is a monocentric observational study performed in the University Hospital of Lille, among adult patients admitted in ICU for hypoxemic and non hypercapnic acute respiratory failure for less than 48 hours

Description

Inclusion Criteria:

Age > 18 years Registered in the French National Health Insurance system

Presenting all the following criteria:

• Admission in ICU for less than 48 hours
• Type 1 acute respiratory failure: hypoxemia (PaO2< 60 mmHg on room air) without hypercapnia (PaCO2 < 45 mmHg)
• Requiring oxygen support of ≥ 5L./min
• Necessitating transthoracic echocardiography for diagnostic purposes

Exclusion Criteria:

Pregnancy Adult with disability or without social protection BMI > 35 kg/m² Withhold decision regarding invasive mechanical ventilation Moribund state diagnosed as a SOFA score > 20

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association between fluid responsiveness and death or the need of invasive mechanical ventilation	Association between fluid responsiveness and death or the need of invasive mechanical ventilation	Death by day 28, Need of invasive mechanical ventilation by day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	All cause mortality	Day-28 and day-90
Need of invasive mechanical ventilation	Need of invasive mechanical ventilation	Day-28
Days alive without vasopressor agents	Days alive without vasopressor agents	Day-28
Days alive without mechanical ventilation or oxygen support	Days alive without mechanical ventilation or oxygen support	Day-28
Days alive without renal replacement therapy	Days alive without renal replacement therapy	Day-28
Days alive without vasopressor agents, mechanical ventilation, oxygen support, and renal replacement therapy	Days alive without vasopressor agents, mechanical ventilation, oxygen support, and renal replacement therapy	Day-28

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Actual): October 22, 2024
• Study Completion (Actual): October 22, 2024

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: respiratory failure; Fluid responsiveness; inferior vena cava; spontaneously breathing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 2022_0232; 2022-A02813-40 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No