Acute Respiratory Distress SyndromeVT4HEMODNCT05406570
Personalized Tidal Volume in ARDS (VT4HEMOD)
A study testing Standardized ventilation and Personalized ventilation in people with Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Treatment of acute respiratory distress syndrome (ARDS) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). Mortality of ARDS remains high in observational studies (40 to 50%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Standardized ventilation and Personalized ventilation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 29 Dec 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age greater then 18 years old
- ARDS according to the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg
- invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight
- use of sedation and neuromuscular-blocking agents
- arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution
- central venous catheter implanted in the superior vena cava territory
- esophageal balloon
- Computed tomography planned by attending physician
Who cannot join
- Previous inclusion in current study
- Acute cor pulmonale
- ECMO
- Arterial pH < 7.21 despite respiratory rate set to a maximum of 35/min
- Pneumothorax or bronchopleural fistula
- Decision to withdraw or withhold life sustaining treatment with 24 hours from inclusion
Show all 25Show fewer
- Contra-indication of transport to imaging facility
- Intracranial hypertension
- Tricuspid or pulmonary mechanical valve
- Tricuspid or pulmonary infective endocarditis
- Pace maker with intracardiac leads
- Right ventricle tumor
- Complete left bundle block
- Intrathoracic metallic device
- COPD
- Cardiac arrythmia
- Vesical pressure > 15 mm Hg
- Lower limb amputation
- Inferior vena cava thrombosis
- Patient under an exclusion period relative to participation to another clinical trial
- Patient under a legal protective measure
- Patient not affiliated to social security
- lac of patient/representative consent
- Pregnancy
- Breast feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation
Lyon, 69004
Jean-Christophe RICHARD, +33 426109272, j-christophe.richard@chu-lyon.fr
William Danjou, +33 472071762, william.danjou@chu-lyon.fr
About this study
Official title: Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS
Treatment of acute respiratory distress syndrome (ARDS) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). Mortality of ARDS remains high in observational studies (40 to 50%). Approximately 30% of ARDS patients exhibit tidal hyperinflation despite low tidal volume ventilation, suggesting that personalization of tidal volume is required to improve ARDS prognostic. To date, reliable bedside tools to adjust tidal volume are lacking. Excessive tidal volume can be detected using computed tomography by quantification of tidal hyperinflation, but this technique is reserved to research studies and requires patient transport to imaging facility.
Mechanical ventilation generates cardio-pulmonary interaction, whose magnitude is influenced by tidal volume and respiratory system characteristics. Pulse pressure variation is a bedside tool with potential to quantify cardio-pulmonary interactions. Increasing tidal volume will decrease right ventricular preload and increase right ventricular afterload, hence maximizing cardio-pulmonary interactions.
The investigators hypothesize that pulse pressure variation might help to detect excessive tidal volume during a tidal volume challenge (i.e. stepwise increase in tidal volume)
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Standardized ventilation, Personalized ventilation
- Keywords
- Acute Respiratory Distress Syndrome, cardiopulmonary interaction, tidal volume, computed tomography
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized ventilationProcedure or surgery
Patient will be ventilated with tidal volume 6 mL/kg predicted body weight (PBW) and positive end-expiratory pressure (PEEP) according to the PEEP-FiO2 table of the ARMA trial. A CT scan will be performed with this ventilatory setting and the patients will be switched to the other group
Personalized ventilationProcedure or surgery
Patient will be ventilated with PEEP according to the PEEP-FiO2 table of the ARMA trial. Tidal volume will be selected as the tidal volume minimizing cardiopulmonary interactions as assessed on arterial pressure tracing, during a VT trial. A CT scan will be performed with this ventilatory setting and the patients will be switched to the other group.
| Study group | Role | What they receive |
|---|---|---|
| Standardized tidal volume | Active comparator | Ventilation with tidal volume 6 ml/kg Receives: Procedure: Standardized ventilation; Procedure: Personalized ventilation |
| Personalized tidal volume | Experimental | Ventilation with tidal volume aiming to minimize cardiopulmonary interactions as assessed by pulse pressure variation Receives: Procedure: Standardized ventilation; Procedure: Personalized ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal hyperinflation
Difference between hyperinflated volume in computed tomography images acquired at end-inspiration (defined by the volume of voxels with CT-number < -900) and hyperinflated volume in computed tomography images acquired at end-expiration (defined by the volume of voxels with CT-number < -900). This difference will be standardized to predicted body weight using the formula of the ARMA trial.
Measured: 5 minutes - This endpoint will be assessed 5 minutes after ventilatory adjustment
Secondary outcomes (1)
Tidal volume
Standardized versus personalized tidal volume
Measured: 5 hours - This endpoint will be assessed through study completion (approximately 4-5 hours after study inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start29 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406570
- Sponsor's protocol ID
- 69HCL21_1272
- Other IDs
- 2021-A02996-35
- Acronym
- VT4HEMOD
- Status last verified
- Nov 2024
- First submitted
- 2 Jun 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS
- ClinicalTrials.gov ID
- NCT05406570
- Acronym / sponsor ID
- VT4HEMOD / 69HCL21_1272
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute Respiratory Distress Syndrome, cardiopulmonary interaction, tidal volume, computed tomography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jun 2022 (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.
Treatment of acute respiratory distress syndrome (ARDS) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). Mortality of ARDS remains high in observational studies (40 to 50%). Approximately 30% of ARDS patients exhibit tidal hyperinflation despite low tidal volume ventilation, suggesting that personalization of tidal volume is required to improve ARDS prognostic. To date, reliable bedside tools to adjust tidal volume are lacking. Excessive tidal volume can be detected using computed tomography by quantification of tidal hyperinflation, but this technique is reserved to research studies and requires patient transport to imaging facility.
Mechanical ventilation generates cardio-pulmonary interaction, whose magnitude is influenced by tidal volume and respiratory system characteristics. Pulse pressure variation is a bedside tool with potential to quantify cardio-pulmonary interactions. Increasing tidal volume will decrease right ventricular preload and increase right ventricular afterload, hence maximizing cardio-pulmonary interactions.
The investigators hypothesize that pulse pressure variation might help to detect excessive tidal volume during a tidal volume challenge (i.e. stepwise increase in tidal volume)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized tidal volume | Active comparator | Procedure: Standardized ventilation, Procedure: Personalized ventilationVentilation with tidal volume 6 ml/kg |
| Personalized tidal volume | Experimental | Procedure: Standardized ventilation, Procedure: Personalized ventilationVentilation with tidal volume aiming to minimize cardiopulmonary interactions as assessed by pulse pressure variation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater then 18 years old
- ARDS according to the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg
- invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight
- use of sedation and neuromuscular-blocking agents
- arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution
Key exclusion criteria (25 listed)
- Previous inclusion in current study
- Acute cor pulmonale
- ECMO
- Arterial pH < 7.21 despite respiratory rate set to a maximum of 35/min
- Pneumothorax or bronchopleural fistula
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized ventilationPatient will be ventilated with tidal volume 6 mL/kg predicted body weight (PBW) and positive end-expiratory pressure (PEEP) according to the PEEP-FiO2 table of the ARMA trial. A CT scan will be performed with this ventilatory setting and the patients will be switched to the other group | Procedure or surgery | Personalized tidal volume, Standardized tidal volume |
| Personalized ventilationPatient will be ventilated with PEEP according to the PEEP-FiO2 table of the ARMA trial. Tidal volume will be selected as the tidal volume minimizing cardiopulmonary interactions as assessed on arterial pressure tracing, during a VT trial. A CT scan will be performed with this ventilatory setting and the patients will be switched to the other group. | Procedure or surgery | Personalized tidal volume, Standardized tidal volume |
Primary outcome
Tidal hyperinflation
Time frame: 5 minutes - This endpoint will be assessed 5 minutes after ventilatory adjustment
Difference between hyperinflated volume in computed tomography images acquired at end-inspiration (defined by the volume of voxels with CT-number < -900) and hyperinflated volume in computed tomography images acquired at end-expiration (defined by the volume of voxels with CT-number < -900). This difference will be standardized to predicted body weight using the formula of the ARMA trial.
1 secondary outcome
Tidal volume
Time frame: 5 hours - This endpoint will be assessed through study completion (approximately 4-5 hours after study inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized ventilation and Personalized ventilation in people with Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon 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 8 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe RICHARD (+33 426109272, j-christophe.richard@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal hyperinflation (time frame: 5 minutes - This endpoint will be assessed 5 minutes after ventilatory adjustment). 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 Nov 2024.