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

May 18, 2026 updated by: University Hospital, Lille

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Association between fluid responsiveness and death or the need of invasive mechanical ventilation
Time Frame: Death by day 28, Need of invasive mechanical ventilation by day 28
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All cause mortality
Time Frame: Day-28 and day-90
All cause mortality
Day-28 and day-90
Need of invasive mechanical ventilation
Time Frame: Day-28
Need of invasive mechanical ventilation
Day-28
Days alive without vasopressor agents
Time Frame: Day-28
Days alive without vasopressor agents
Day-28
Days alive without mechanical ventilation or oxygen support
Time Frame: Day-28
Days alive without mechanical ventilation or oxygen support
Day-28
Days alive without renal replacement therapy
Time Frame: Day-28
Days alive without renal replacement therapy
Day-28
Days alive without vasopressor agents, mechanical ventilation, oxygen support, and renal replacement therapy
Time Frame: Day-28
Days alive without vasopressor agents, mechanical ventilation, oxygen support, and renal replacement therapy
Day-28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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