ARDSTCAV-CTNCT05874973
Effects of TCAV and Volume Control Ventilation on the Distribution of Aerated Lung Parenchyma in ARDS Patients
A study of ARDS, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure with mortality rates reaching as high as 35%. Management of ARDS is based on the treatment (if possible) of the underlying cause of ARDS and on invasive mechanical ventilation with positive expiratory pressure (PEEP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2023to 30 Dec 2024
- Phase
- Interventional
- 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
Who may be able to join
- ARDS according to the Berlin definition
- invasive ventilation for no longer than 72 hours
- patient requiring a diagnostic thoracic CT scan
- consent of a family member or the person of trust
- social security affiliation
Who cannot join
- Use of iodinated contrast media injection before CT acquisitions
- ARDS criteria present during 72 hours or more
- Severe COPD
- Pneumothorax or other barotrauma-related complication
- Right ventricular failure other than acute cor pulmonale
- Absence of sedative agents and neuromuscular blockade
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- Severe hemodynamic instability (norepinephrine > 0.5 µg/kg/min)
- VA-ECMO assistance
- Pregnancy
- Absence of the capacity to give consent before admission to the ICU
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU
Nancy
Benjamin Pequignot, MD, +33383153851, b.pequignot@chru-nancy.fr
About this study
Official title: Effects of Time-controlled Adaptive Ventilation (TCAV) and Volume Control Ventilation (VCV) on the Distribution of Aerated Lung Parenchyma in Patients With Acute Respiratory Distress Syndrome (ARDS): a Pilot Study
Acute respiratory distress syndrome (ARDS) is a severe form of acute respiratory failure with mortality rates reaching as high as 35%. Management of ARDS is based on the treatment (if possible) of the underlying cause of ARDS and on invasive mechanical ventilation with positive expiratory pressure (PEEP). Another strategy of invasive ventilation, Time-Controlled Adaptative Ventilation (TCAV), is the application of specific settings to the airway pressure release ventilation (APRV) mode.
TCAV is based on a prolonged time at plateau pressure, creating a phase of continuous positive pressure, associated with brief release phases allowing the elimination of carbon dioxide. In prospective and retrospective clinical reviews, as well as in experimental animal studies, TCAV has demonstrated improvements in oxygenation and lung function, with the ability to prevent ARDS.
Read more
The thoracic computed tomography (CT) scan evaluates lung recruitment (re-aeration by positive pressure of non-ventilated lung territories) and the adverse effects of positive pressure on the parenchyma (hyperinflation).
The objective of this study is to evaluate, with CT scans performed to assess lungs of patients with ARDS, the effects of TCAV compared to a standard volumetric controlled ventilation, by measuring alveolar recruitment and over-distension.
- Conditions
- ARDS
- Being tested
- Time-controlled adaptative ventilation (TCAV), Volume-controlled ventilation (VCV)
- Keywords
- Mechanical Ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-controlled adaptative ventilation (TCAV)Other
Ventilation with TCAV set on the APRV mode on the ventilator.
Volume-controlled ventilation (VCV)Other
Ventilation with the VCV mode set on the ventilator.
| Study group | Role | What they receive |
|---|---|---|
| Time-Controlled Adaptative Ventilation (TCAV) | Experimental | APRV mode set with:
* a Phigh at Plateau Pressure of the VCV mode
* a Tlow set to terminate the expiration at 75% of the maximal expiratory flow
* a Plow set at 0 cmH2O.
* a Thigh set to achieve adequate decarboxylation. Receives: Other: Time-controlled adaptative ventilation (TCAV) |
| Volume Control Ventilation (VCV) | Active comparator | Ventilation with the VCV mode set with:
* a tidal volume (VT) at or below 6 ml/kg of predicted body weight
* a positive end-expiratory pressure (PEEP) set at least at 5 cmH2O
* a driving pressure lower than 15 cmH2O. Receives: Other: Volume-controlled ventilation (VCV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of end-expiratory non aerated lung parenchyma
Percentage of non aerated lung parenchyma defined as % of lung at -100 to +100 Hounsfield Units (HU) divided by total lung weight, at the end of expiration.
Measured: during procedure (10 minutes)
Secondary outcomes (5)
End-inspiratory overdistention in TCAV
Percentage of hyper-aerated lung parenchyma defined as lung volume at ≤ - 901 Hounsfield Units (HU) divided by total lung volume, at the end of inspiration in TCAV.
Measured: 10 minutes
Tidal hyperinflation in TCAV
Tidal hyperinflation is defined as the volume of the hyper-aerated (density ≤ - 901 HU) compartment at end-inspiration minus hyper-aerated (density ≤ - 901 HU) volume at end-expiration, and standardized to predicted body weight (PBW), expressed in ml/kg of PBW
Measured: 10 minutes
Atelectrauma in TCAV and VCV
Tidal recruitment of the non-aerated (-100 to +100 Hounsfield Units) compartment was defined as the weight of the non-aerated compartment at end-expiration minus its weight at end-inspiration, and standardized to total lung weight, expressed in %.
Measured: 10 minutes
Correlation between transpulmonary driving pressure and tidal hyperinflation in TCAV
Area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation
Measured: 10 minutes
Correlation between driving pressure and tidal hyperinflation in TCAV
Area under ROC curve of driving pressure to detect cyclic hyperinflation
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start25 Oct 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PEQUIGNOT Benjamin, Central Hospital, Nancy, France
- Investigators
- Benjamin Pequignot, Principal investigator, CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874973
- Sponsor's protocol ID
- 2021PI212
- Acronym
- TCAV-CT
- Status last verified
- Feb 2024
- First submitted
- 16 May 2023
- Last updated
- 7 Feb 2024
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Time-controlled Adaptive Ventilation (TCAV) and Volume Control Ventilation (VCV) on the Distribution of Aerated Lung Parenchyma in Patients With Acute Respiratory Distress Syndrome (ARDS): a Pilot Study
- ClinicalTrials.gov ID
- NCT05874973
- Acronym / sponsor ID
- TCAV-CT / 2021PI212
- Conditions
- ARDS
- Keywords
- Mechanical Ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 25 May 2023 (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 distress syndrome (ARDS) is a severe form of acute respiratory failure with mortality rates reaching as high as 35%. Management of ARDS is based on the treatment (if possible) of the underlying cause of ARDS and on invasive mechanical ventilation with positive expiratory pressure (PEEP). Another strategy of invasive ventilation, Time-Controlled Adaptative Ventilation (TCAV), is the application of specific settings to the airway pressure release ventilation (APRV) mode.
TCAV is based on a prolonged time at plateau pressure, creating a phase of continuous positive pressure, associated with brief release phases allowing the elimination of carbon dioxide. In prospective and retrospective clinical reviews, as well as in experimental animal studies, TCAV has demonstrated improvements in oxygenation and lung function, with the ability to prevent ARDS.
The thoracic computed tomography (CT) scan evaluates lung recruitment (re-aeration by positive pressure of non-ventilated lung territories) and the adverse effects of positive pressure on the parenchyma (hyperinflation).
The objective of this study is to evaluate, with CT scans performed to assess lungs of patients with ARDS, the effects of TCAV compared to a standard volumetric controlled ventilation, by measuring alveolar recruitment and over-distension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-Controlled Adaptative Ventilation (TCAV) | Experimental | Other: Time-controlled adaptative ventilation (TCAV)APRV mode set with: * a Phigh at Plateau Pressure of the VCV mode * a Tlow set to terminate the expiration at 75% of the maximal expiratory flow * a Plow set at 0 cmH2O. * a Thigh set to achieve adequate decarboxylation. |
| Volume Control Ventilation (VCV) | Active comparator | Other: Volume-controlled ventilation (VCV)Ventilation with the VCV mode set with: * a tidal volume (VT) at or below 6 ml/kg of predicted body weight * a positive end-expiratory pressure (PEEP) set at least at 5 cmH2O * a driving pressure lower than 15 cmH2O. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ARDS according to the Berlin definition
- invasive ventilation for no longer than 72 hours
- patient requiring a diagnostic thoracic CT scan
- consent of a family member or the person of trust
- social security affiliation
Key exclusion criteria (10 listed)
- Use of iodinated contrast media injection before CT acquisitions
- ARDS criteria present during 72 hours or more
- Severe COPD
- Pneumothorax or other barotrauma-related complication
- Right ventricular failure other than acute cor pulmonale
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 |
|---|---|---|
| Time-controlled adaptative ventilation (TCAV)Ventilation with TCAV set on the APRV mode on the ventilator. | Other | Time-Controlled Adaptative Ventilation (TCAV) |
| Volume-controlled ventilation (VCV)Ventilation with the VCV mode set on the ventilator. | Other | Volume Control Ventilation (VCV) |
Primary outcome
Percentage of end-expiratory non aerated lung parenchyma
Time frame: during procedure (10 minutes)
Percentage of non aerated lung parenchyma defined as % of lung at -100 to +100 Hounsfield Units (HU) divided by total lung weight, at the end of expiration.
5 secondary outcomes
End-inspiratory overdistention in TCAV
Time frame: 10 minutes
Tidal hyperinflation in TCAV
Time frame: 10 minutes
Atelectrauma in TCAV and VCV
Time frame: 10 minutes
Correlation between transpulmonary driving pressure and tidal hyperinflation in TCAV
Time frame: 10 minutes
Correlation between driving pressure and tidal hyperinflation in TCAV
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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. This study is not recruiting at the moment.
Benjamin Pequignot principal investigator
CHRU Nancy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of ARDS, run by Central Hospital, Nancy, France 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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 7 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Pequignot, MD (+33383153851, b.pequignot@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of end-expiratory non aerated lung parenchyma (time frame: during procedure (10 minutes)). 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 7 Feb 2024.