Hypoxemic Without Hypercapnia Acute Respiratory FailurePRIVACYNCT06286306
Pronostic Value of Fluid Responsiveness Evaluated by Inferior Vena Cava Collapsibility Index in Patients Admitted in ICU With Acute Respiratory Failure
An observational study of Hypoxemic Without Hypercapnia Acute Respiratory Failure, run by University Hospital, Lille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemic Without Hypercapnia Acute Respiratory Failure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2023to 22 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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).
Read the 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.
- Keywords
- Fluid responsiveness, spontaneously breathing, inferior vena cava, respiratory failure
- Medical subject headings
- Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Death by day 28, Need of invasive mechanical ventilation by day 28
Secondary outcomes (6)
All cause mortality
All cause mortality
Measured: Day-28 and day-90
Need of invasive mechanical ventilation
Need of invasive mechanical ventilation
Measured: Day-28
Days alive without vasopressor agents
Days alive without vasopressor agents
Measured: Day-28
Days alive without mechanical ventilation or oxygen support
Days alive without mechanical ventilation or oxygen support
Measured: Day-28
Days alive without renal replacement therapy
Days alive without renal replacement therapy
Measured: 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
Measured: Day-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start24 Feb 2023
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxemic Without Hypercapnia Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286306
- Sponsor's protocol ID
- 2022_0232
- Other IDs
- 2022-A02813-40
- Acronym
- PRIVACY
- Status last verified
- May 2026
- First submitted
- 22 Feb 2024
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pronostic Value of Fluid Responsiveness, Evaluated by Inferior Vena Cava Collapsibility Index, in Patients Admitted in ICU With Acute Respiratory Failure '' PRIVACY Study''
- ClinicalTrials.gov ID
- NCT06286306
- Acronym / sponsor ID
- PRIVACY / 2022_0232
- Keywords
- Fluid responsiveness, spontaneously breathing, inferior vena cava, respiratory failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- Age > 18 years Registered in the French National Health Insurance system
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
All cause mortality
Time frame: Day-28 and day-90
Need of invasive mechanical ventilation
Time frame: Day-28
Days alive without vasopressor agents
Time frame: Day-28
Days alive without mechanical ventilation or oxygen support
Time frame: Day-28
Days alive without renal replacement therapy
Time frame: Day-28
Days alive without vasopressor agents, mechanical ventilation, oxygen support, and renal replacement therapy
Time frame: Day-28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemic Without Hypercapnia Acute Respiratory Failure, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.