Acute Respiratory Distress Syndrome (ARDS)PV-TOOLNCT07713420
COMPARISON OF LUNG RECRUITABILITY ASSESSMENT BY HYSTERESIS RATIO AND RECRUITMENT-TO-INFLATION RATIO, AND PEEP TITRATION IN ARDS.
A study testing Physiological lung recruitability assessment and PEEP titration protocol in people with Acute Respiratory Distress Syndrome (ARDS), run by Oriol Roca.
Trial summary
This multicenter, single-blind physiological study aims to compare two bedside methods for assessing lung recruitability in mechanically ventilated patients with acute respiratory distress syndrome (ARDS): the recruitment-to-inflation (R/I) ratio and the pressure-volume (PV) loop hysteresis ratio. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Physiological lung recruitability assessment and PEEP titration protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Jan 2029
- 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
- Intubated patients with acute respiratory distress syndrome (ARDS): PaO2/FiO2 ratio <200, with bilateral infiltrates of non-cardiogenic origin, with a PEEP of at least 5 cmH2O.
- The patient is receiving mechanical ventilation and continuous sedation.
- The patient has an esophageal balloon.
- Written informed consent signed and dated by the patient or one relative in case the patient is unable to consent, after a full explanation of the study by the investigator and prior to study participation
Who cannot join
- Patients with< 18 years old
- Pregnant woman
- Lung recruitment maneuvers are deemed unsafe by the medical team
- Unable to fit EIT belt due to patient size
- Contraindications to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement)
- Hemodynamic instability (Systolic BP < 75 mmHg or MAP < 60 mmHg despite vasopressors and/or heart rate < 55 bpm)
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- Hypernatremia (Na+ >145mEq/L)
- The formalized ethical decision to withhold or withdraw life support
- Patient under guardianship
- Patients deprived of liberties
- Impossibility to give informed consent by both patient and family (i.e. language barrier)
- Patient was already enrolled in the present study in a previous episode of acute respiratory failure.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: COMPARISON OF LUNG RECRUITABILITY ASSESSMENT BY HYSTERESIS RATIO AND RECRUITMENT-TO-INFLATION RATIO AND THE USE OF DIFFERENT PEEP TITRATION METHODS IN PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)
This multicenter, single-blind physiological study aims to compare two bedside methods for assessing lung recruitability in mechanically ventilated patients with acute respiratory distress syndrome (ARDS): the recruitment-to-inflation (R/I) ratio and the pressure-volume (PV) loop hysteresis ratio. Lung recruitability will be defined according to the reduction in lung collapse measured by electrical impedance tomography (EIT) during a standardized lung recruitment maneuver.
Following baseline measurements, participants will undergo sequential physiological assessments, including lung recruitability evaluation using both the R/I ratio and a low-flow PV loop, a standardized lung recruitment maneuver with a decremental PEEP trial, and a second PV loop performed at a lower maximum inflation pressure. The order of the R/I ratio assessment and the PV loop maneuver will be randomized.
Read more
In a final crossover phase, four different PEEP titration strategies will be evaluated in randomized order. Each strategy will be applied for 15 minutes and separated by a washout period at the patient's baseline clinical PEEP. Respiratory mechanics, gas exchange, ventilation/perfusion distribution, and hemodynamic variables will be assessed throughout the protocol.
The primary objective is to determine the agreement between the hysteresis ratio and the R/I ratio for identifying lung recruitability. Secondary objectives include evaluating whether a PV loop performed with a lower maximum pressure provides similar information on recruitability and comparing the physiological effects of different PEEP titration strategies. Approximately 30 patients with moderate-to-severe ARDS receiving invasive mechanical ventilation will be enrolled.
Read the detailed description
Acute respiratory distress syndrome (ARDS) is a severe form of respiratory failure that requires mechanical ventilation. One of the main challenges in ventilator management is selecting the optimal level of positive end-expiratory pressure (PEEP), as patients differ in their potential for lung recruitment. Individualizing PEEP may help improve lung protection by reducing lung collapse while avoiding overdistension. The study is designed to improve the understanding of bedside tools for assessing lung recruitability and to evaluate their potential role in personalizing mechanical ventilation in patients with ARDS.
Patients meeting the inclusion criteria will be enrolled in this multicenter, single-blind physiological study after informed consent has been obtained. Continuous monitoring will include electrical impedance tomography (EIT), esophageal pressure, mechanical ventilation parameters, end-tidal carbon dioxide, and standard hemodynamic monitoring throughout the study protocol.
After enrollment, a fluid responsiveness assessment will be performed using a standardized tidal volume challenge to optimize hemodynamic conditions before study interventions. Baseline measurements will then be obtained after 15 minutes at the patient's clinical ventilator settings and will include respiratory mechanics, arterial blood gases, ventilation/perfusion (V/Q) analysis, and hemodynamic variables.
The primary endpoint is the comparison between the hysteresis ratio and the recruitment-to-inflation ratio for the assessment of lung recruitability, using the reduction in lung collapse measured by EIT as the reference standard. Secondary endpoints include comparison of recruitability assessment obtained with PV loops performed at maximum inflation pressures of 40 and 30 cmH₂O, and evaluation of the physiological effects of different PEEP titration methods on respiratory mechanics, ventilation/perfusion matching, gas exchange, and hemodynamics. Clinical outcomes, including duration of mechanical ventilation, ICU and hospital length of stay, and mortality, will also be recorded.
The first study phase evaluates lung recruitability using two bedside methods: the recruitment-to-inflation (R/I) ratio and a low-flow pressure-volume loop with a maximum pressure of 40 cmH₂O (PVloop40). The order of these two assessments will be computer-randomized. During the R/I assessment, measurements will be obtained at PEEP levels of 5 and 15 cmH₂O, followed by a single-breath maneuver to calculate the recruitment-to-inflation ratio. The PVloop40 maneuver will be used to calculate the hysteresis ratio from the inspiratory and expiratory limbs of the pressure-volume curve.
Following recruitability assessment, patients will undergo a standardized lung recruitment maneuver. PEEP will be progressively increased from 5 to 24 cmH₂O with intermediate stabilization periods to assess patient tolerance. After recruitment, respiratory mechanics, arterial blood gases, and hemodynamic measurements will be repeated at the highest PEEP level.
A decremental PEEP trial will subsequently be performed from 24 to 6 cmH₂O using 2 cmH₂O decrements maintained for at least 3 minutes each. Electrical impedance tomography data obtained during this maneuver will be used to quantify regional lung collapse and overdistension and to identify the optimal PEEP according to EIT-derived criteria. After completion of the decremental trial, a second low-flow pressure-volume loop with a maximum pressure of 30 cmH₂O (PVloop30) will be performed to determine whether recruitability can be accurately assessed using lower inflation pressures.
In the final phase, participants will undergo a randomized crossover comparison of four PEEP titration strategies: (1) transpulmonary pressure-guided PEEP, (2) EIT-guided PEEP, (3) R/I ratio-guided PEEP, and (4) compliance-guided PEEP. The order of the four strategies will be computer-generated. Each PEEP strategy will be maintained for 15 minutes, followed by assessment of respiratory mechanics, ventilation/perfusion matching, and hemodynamic variables. Between interventions, patients will return to their baseline clinical PEEP for a 15-minute washout period before initiation of the next strategy.
- Being tested
- Physiological lung recruitability assessment and PEEP titration protocol
- Keywords
- Mechanical ventilation, Lung recruitability, PEEP titration, Hysteresis Ratio, Recruitment-to-Inflation Ratio, Pressure-Volume Loop, Electrical Impedance Tomography (EIT), Esophageal Pressure, Acute Respiratory Distress Syndrome
- 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.
Physiological lung recruitability assessment and PEEP titration protocolProcedure or surgery
Participants undergo a standardized physiological protocol including lung recruitability assessment using the recruitment-to-inflation ratio and pressure-volume loop hysteresis ratio, a standardized lung recruitment maneuver, a decremental PEEP trial, and crossover evaluation of four PEEP titration strategies based on transpulmonary pressure, electrical impedance tomography, respiratory system compliance, and the recruitment-to-inflation ratio. The order of the recruitability assessments and PEEP titration strategies is randomized.
| Study group | Role | What they receive |
|---|---|---|
| Physiological study protocol | Experimental | Participants undergo the complete physiological study protocol, including assessment of lung recruitability, standardized lung recruitment, decremental PEEP trial, and randomized crossover evaluation of four PEEP titration strategies. All participants receive every study intervention; only the order of selected procedures is randomized. Receives: Procedure: Physiological lung recruitability assessment and PEEP titration protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between the hysteresis ratio and the recruitment-to-inflation (R/I) ratio for assessing lung recruitability
Agreement between lung recruitability assessed by the hysteresis ratio obtained from the pressure-volume loop and the recruitment-to-inflation (R/I) ratio, using the reduction in lung collapse measured by electrical impedance tomography (EIT) during the recruitment maneuver as the reference standard.
Measured: During the study procedure (approximately within 2-3 hours after enrollment).
Secondary outcomes (2)
Agreement between PVloop30 and PVloop40 for the assessment of lung recruitability
Comparison of lung recruitability assessment obtained from the hysteresis ratio measured using a low-flow pressure-volume loop with a maximum inflation pressure of 30 cmH₂O (PVloop30) and 40 cmH₂O (PVloop40), to determine whether a lower-pressure PV loop provides comparable information on lung recruitability
Measured: During the study procedure.
Respiratory mechanics and ventilation/perfusion (V/Q) changes according to different PEEP titration methods
Comparison of respiratory mechanics and ventilation/perfusion (V/Q) distribution between four different PEEP titration strategies: transpulmonary pressure-guided PEEP, electrical impedance tomography-guided PEEP, recruitment-to-inflation ratio-guided PEEP, and respiratory system compliance-guided PEEP.
Measured: During the study procedure, after 15 minutes of each randomized PEEP titration strategy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oriol Roca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oriol Roca, Parc Taulí Hospital Universitari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713420
- Sponsor's protocol ID
- PRNA018/25
- Acronym
- PV-TOOL
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Publications
Mauri T, Eronia N, Turrini C, Battistini M, Grasselli G, Rona R, Volta CA, Bellani G, Pesenti A. Bedside assessment of the effects of positive end-expiratory pressure on lung inflation and recruitment by the helium dilution technique and electrical impedance tomography. Intensive Care Med. 2016 Oct;42(10):1576-1587. doi: 10.1007/s00134-016-4467-4. Epub 2016 Aug 12.
PubMed 27518321Scaramuzzo G, Spadaro S, Dalla Corte F, Waldmann AD, Bohm SH, Ragazzi R, Marangoni E, Grasselli G, Pesenti A, Volta CA, Mauri T. Personalized Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome: Comparison Between Optimal Distribution of Regional Ventilation and Positive Transpulmonary Pressure. Crit Care Med. 2020 Aug;48(8):1148-1156. doi: 10.1097/CCM.0000000000004439.
PubMed 32697485Millington SJ, Cardinal P, Brochard L. Setting and Titrating Positive End-Expiratory Pressure. Chest. 2022 Jun;161(6):1566-1575. doi: 10.1016/j.chest.2022.01.052. Epub 2022 Feb 5.
PubMed 35131298Chiumello D, Arnal JM, Umbrello M, Cammaroto A, Formenti P, Mistraletti G, Bolgiaghi L, Gotti M, Novotni D, Reidt S, Froio S, Coppola S. Hysteresis and Lung Recruitment in Acute Respiratory Distress Syndrome Patients: A CT Scan Study. Crit Care Med. 2020 Oct;48(10):1494-1502. doi: 10.1097/CCM.0000000000004518.
PubMed 32897667Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.
PubMed 31577153
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF LUNG RECRUITABILITY ASSESSMENT BY HYSTERESIS RATIO AND RECRUITMENT-TO-INFLATION RATIO AND THE USE OF DIFFERENT PEEP TITRATION METHODS IN PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)
- ClinicalTrials.gov ID
- NCT07713420
- Acronym / sponsor ID
- PV-TOOL / PRNA018/25
- Keywords
- Mechanical ventilation, Lung recruitability, PEEP titration, Hysteresis Ratio, Recruitment-to-Inflation Ratio, Pressure-Volume Loop, Electrical Impedance Tomography (EIT), Esophageal Pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oriol RocaUniversity, hospital or other
- Study start
- Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 20 Jul 2026 (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.
This multicenter, single-blind physiological study aims to compare two bedside methods for assessing lung recruitability in mechanically ventilated patients with acute respiratory distress syndrome (ARDS): the recruitment-to-inflation (R/I) ratio and the pressure-volume (PV) loop hysteresis ratio. Lung recruitability will be defined according to the reduction in lung collapse measured by electrical impedance tomography (EIT) during a standardized lung recruitment maneuver.
Following baseline measurements, participants will undergo sequential physiological assessments, including lung recruitability evaluation using both the R/I ratio and a low-flow PV loop, a standardized lung recruitment maneuver with a decremental PEEP trial, and a second PV loop performed at a lower maximum inflation pressure. The order of the R/I ratio assessment and the PV loop maneuver will be randomized.
In a final crossover phase, four different PEEP titration strategies will be evaluated in randomized order. Each strategy will be applied for 15 minutes and separated by a washout period at the patient's baseline clinical PEEP. Respiratory mechanics, gas exchange, ventilation/perfusion distribution, and hemodynamic variables will be assessed throughout the protocol.
The primary objective is to determine the agreement between the hysteresis ratio and the R/I ratio for identifying lung recruitability. Secondary objectives include evaluating whether a PV loop performed with a lower maximum pressure provides similar information on recruitability and comparing the physiological effects of different PEEP titration strategies. Approximately 30 patients with moderate-to-severe ARDS receiving invasive mechanical ventilation will be enrolled.
Detailed description
Acute respiratory distress syndrome (ARDS) is a severe form of respiratory failure that requires mechanical ventilation. One of the main challenges in ventilator management is selecting the optimal level of positive end-expiratory pressure (PEEP), as patients differ in their potential for lung recruitment. Individualizing PEEP may help improve lung protection by reducing lung collapse while avoiding overdistension. The study is designed to improve the understanding of bedside tools for assessing lung recruitability and to evaluate their potential role in personalizing mechanical ventilation in patients with ARDS.
Patients meeting the inclusion criteria will be enrolled in this multicenter, single-blind physiological study after informed consent has been obtained. Continuous monitoring will include electrical impedance tomography (EIT), esophageal pressure, mechanical ventilation parameters, end-tidal carbon dioxide, and standard hemodynamic monitoring throughout the study protocol.
After enrollment, a fluid responsiveness assessment will be performed using a standardized tidal volume challenge to optimize hemodynamic conditions before study interventions. Baseline measurements will then be obtained after 15 minutes at the patient's clinical ventilator settings and will include respiratory mechanics, arterial blood gases, ventilation/perfusion (V/Q) analysis, and hemodynamic variables.
The primary endpoint is the comparison between the hysteresis ratio and the recruitment-to-inflation ratio for the assessment of lung recruitability, using the reduction in lung collapse measured by EIT as the reference standard. Secondary endpoints include comparison of recruitability assessment obtained with PV loops performed at maximum inflation pressures of 40 and 30 cmH₂O, and evaluation of the physiological effects of different PEEP titration methods on respiratory mechanics, ventilation/perfusion matching, gas exchange, and hemodynamics. Clinical outcomes, including duration of mechanical ventilation, ICU and hospital length of stay, and mortality, will also be recorded.
The first study phase evaluates lung recruitability using two bedside methods: the recruitment-to-inflation (R/I) ratio and a low-flow pressure-volume loop with a maximum pressure of 40 cmH₂O (PVloop40). The order of these two assessments will be computer-randomized. During the R/I assessment, measurements will be obtained at PEEP levels of 5 and 15 cmH₂O, followed by a single-breath maneuver to calculate the recruitment-to-inflation ratio. The PVloop40 maneuver will be used to calculate the hysteresis ratio from the inspiratory and expiratory limbs of the pressure-volume curve.
Following recruitability assessment, patients will undergo a standardized lung recruitment maneuver. PEEP will be progressively increased from 5 to 24 cmH₂O with intermediate stabilization periods to assess patient tolerance. After recruitment, respiratory mechanics, arterial blood gases, and hemodynamic measurements will be repeated at the highest PEEP level.
A decremental PEEP trial will subsequently be performed from 24 to 6 cmH₂O using 2 cmH₂O decrements maintained for at least 3 minutes each. Electrical impedance tomography data obtained during this maneuver will be used to quantify regional lung collapse and overdistension and to identify the optimal PEEP according to EIT-derived criteria. After completion of the decremental trial, a second low-flow pressure-volume loop with a maximum pressure of 30 cmH₂O (PVloop30) will be performed to determine whether recruitability can be accurately assessed using lower inflation pressures.
In the final phase, participants will undergo a randomized crossover comparison of four PEEP titration strategies: (1) transpulmonary pressure-guided PEEP, (2) EIT-guided PEEP, (3) R/I ratio-guided PEEP, and (4) compliance-guided PEEP. The order of the four strategies will be computer-generated. Each PEEP strategy will be maintained for 15 minutes, followed by assessment of respiratory mechanics, ventilation/perfusion matching, and hemodynamic variables. Between interventions, patients will return to their baseline clinical PEEP for a 15-minute washout period before initiation of the next strategy.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiological study protocol | Experimental | Procedure: Physiological lung recruitability assessment and PEEP titration protocolParticipants undergo the complete physiological study protocol, including assessment of lung recruitability, standardized lung recruitment, decremental PEEP trial, and randomized crossover evaluation of four PEEP titration strategies. All participants receive every study intervention; only the order of selected procedures is randomized. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Intubated patients with acute respiratory distress syndrome (ARDS): PaO2/FiO2 ratio <200, with bilateral infiltrates of non-cardiogenic origin, with a PEEP of at least 5 cmH2O.
- The patient is receiving mechanical ventilation and continuous sedation.
- The patient has an esophageal balloon.
- Written informed consent signed and dated by the patient or one relative in case the patient is unable to consent, after a full explanation of the study by the investigator and prior to study participation
Key exclusion criteria (12 listed)
- Patients with< 18 years old
- Pregnant woman
- Lung recruitment maneuvers are deemed unsafe by the medical team
- Unable to fit EIT belt due to patient size
- Contraindications to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement)
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 |
|---|---|---|
| Physiological lung recruitability assessment and PEEP titration protocolParticipants undergo a standardized physiological protocol including lung recruitability assessment using the recruitment-to-inflation ratio and pressure-volume loop hysteresis ratio, a standardized lung recruitment maneuver, a decremental PEEP trial, and crossover evaluation of four PEEP titration strategies based on transpulmonary pressure, electrical impedance tomography, respiratory system compliance, and the recruitment-to-inflation ratio. The order of the recruitability assessments and PEEP titration strategies is randomized. | Procedure or surgery | Physiological study protocol |
Primary outcome
Agreement between the hysteresis ratio and the recruitment-to-inflation (R/I) ratio for assessing lung recruitability
Time frame: During the study procedure (approximately within 2-3 hours after enrollment).
Agreement between lung recruitability assessed by the hysteresis ratio obtained from the pressure-volume loop and the recruitment-to-inflation (R/I) ratio, using the reduction in lung collapse measured by electrical impedance tomography (EIT) during the recruitment maneuver as the reference standard.
2 secondary outcomes
Agreement between PVloop30 and PVloop40 for the assessment of lung recruitability
Time frame: During the study procedure.
Respiratory mechanics and ventilation/perfusion (V/Q) changes according to different PEEP titration methods
Time frame: During the study procedure, after 15 minutes of each randomized PEEP titration strategy
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 20 Jul 2026.
- Background: PubMed 27518321Mauri T, Eronia N, Turrini C, Battistini M, Grasselli G, Rona R, Volta CA, Bellani G, Pesenti A. Bedside assessment of the effects of positive end-expiratory pressure on lung inflation and recruitment by the helium dilution technique and electrical impedance tomography. Intensive Care Med. 2016 Oct;42(10):1576-1587. doi: 10.1007/s00134-016-4467-4. Epub 2016 Aug 12.
- Background: PubMed 32697485Scaramuzzo G, Spadaro S, Dalla Corte F, Waldmann AD, Bohm SH, Ragazzi R, Marangoni E, Grasselli G, Pesenti A, Volta CA, Mauri T. Personalized Positive End-Expiratory Pressure in Acute Respiratory Distress Syndrome: Comparison Between Optimal Distribution of Regional Ventilation and Positive Transpulmonary Pressure. Crit Care Med. 2020 Aug;48(8):1148-1156. doi: 10.1097/CCM.0000000000004439.
- Background: PubMed 35131298Millington SJ, Cardinal P, Brochard L. Setting and Titrating Positive End-Expiratory Pressure. Chest. 2022 Jun;161(6):1566-1575. doi: 10.1016/j.chest.2022.01.052. Epub 2022 Feb 5.
- Background: PubMed 32897667Chiumello D, Arnal JM, Umbrello M, Cammaroto A, Formenti P, Mistraletti G, Bolgiaghi L, Gotti M, Novotni D, Reidt S, Froio S, Coppola S. Hysteresis and Lung Recruitment in Acute Respiratory Distress Syndrome Patients: A CT Scan Study. Crit Care Med. 2020 Oct;48(10):1494-1502. doi: 10.1097/CCM.0000000000004518.
- Background: PubMed 31577153Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Physiological lung recruitability assessment and PEEP titration protocol in people with Acute Respiratory Distress Syndrome (ARDS), run by Oriol Roca.
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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Oriol Roca, MD, PhD (+34 932607500, oriol.roca@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between the hysteresis ratio and the recruitment-to-inflation (R/I) ratio for assessing lung recruitability (time frame: During the study procedure (approximately within 2-3 hours after enrollment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07713420, which also lists 5 linked publications.
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 20 Jul 2026.