ARDS (Acute Respiratory Distress Syndrome)RECRUIT-PEEPNCT07603310
Influence of Lung Recruitment Potential on Positive End-Expiratory Pressure (PEEP) Titration Strategies in Acute Respiratory Distress Syndrome (ARDS) Patients.
A study testing Positive End-Expiratory Pressure (PEEP) Titration guided by Static Compliance and Positive End-Expiratory Pressure (PEEP) Titration guided by Transpulmonary Pressure in people with ARDS (Acute Respiratory Distress Syndrome), run by Hospital Dr. Franco Ravera Zunino at 1 site in Chile.
Trial summary
Acute Respiratory Distress Syndrome (ARDS) is characterized by severe hypoxemia and diffuse alveolar collapse, often requiring invasive mechanical ventilation. Non-individualized mechanical ventilation settings can cause ventilator-induced lung injury (VILI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- Positive End-Expiratory Pressure (PEEP) Titration guided by Static Compliance and Positive End-Expiratory Pressure (PEEP) Titration guided by Transpulmonary Pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChile
- Study dates
- 1 Jun 2026to 30 Sep 2027
- 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
- Diagnosis of moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: acute onset, bilateral opacities not fully explained by heart failure or fluid overload, and Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen <= 200 mmHg with Positive End-Expiratory Pressure (PEEP) >= 5 cmH2O.
- ARDS duration < 36 hours since fully meeting Berlin consensus criteria.
- Relative hemodynamic stability: absence of refractory shock, defined as norepinephrine dose <= 0.5 mcg/kg/min.
Who cannot join
- Evidence of active pulmonary air leaks (bronchopleural fistula, pneumothorax, pneumomediastinum).
- Severe uncorrected hemodynamic instability (norepinephrine > 0.5 mcg/kg/min).
- Contraindications for esophageal balloon placement (esophageal obstruction, known perforation, recent esophageal surgery, severe esophagitis).
- Elevated intracranial pressure or conditions where hypercapnia-induced increases in intracranial pressure must be avoided (intracranial hemorrhage, cerebral contusion, cerebral edema, mass effect with midline shift on CT).
- Known pregnancy.
- Severe coagulopathy (platelet count < 5,000/uL or INR > 3).
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- Airway opening pressure higher than 15 cmH2O (AOP > 15 cmH2O).
- History of severe neuromuscular disease or chronic respiratory disease.
- Having received invasive mechanical ventilation for more than 96 hours.
- Inability to obtain informed consent or refusal by the legal representative.
- Contained laparotomy (open abdomen).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Dr. Franco Ravera Zunino Hospital
Rancagua, Región del Libertador General Bernardo O’Higgins, 2820000
Renatto Anfossi, 722729383 ext. +569, ranfossi.hrlbo@gmail.com
Carolina Lindsay, PhD, 72 2 729383 ext. +56, c.lindsay.hfrz@gmail.com
About this study
Official title: Influence of the Lung Recruitment Potential on the Response to Two Positive End-Expiratory Pressure (PEEP) Titration Strategies in Patients With Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome (ARDS) is characterized by severe hypoxemia and diffuse alveolar collapse, often requiring invasive mechanical ventilation. Non-individualized mechanical ventilation settings can cause ventilator-induced lung injury (VILI). Positive end-expiratory pressure (PEEP) prevents alveolar collapse, but its effect varies among individuals. The recruitment-to-inflation (R/I) ratio evaluates bedside lung recruitment potential. This pilot study aims to compare two individualized PEEP titration strategies-one guided by the best static respiratory compliance and another guided by transpulmonary pressure via an esophageal balloon-and evaluate how baseline lung recruitment potential alters the early physiological responses to these interventions. Both strategies are preceded by an identical, standardized pressure-controlled initial lung recruitment maneuver to establish a baseline recruitment state.
Read the detailed description
This is a prospective, randomized, open-label, parallel-group pilot study conducted at the Adult Intensive Care Unit of Hospital Dr. Franco Ravera Zunino (HFRZ). Eligible adult patients under invasive mechanical ventilation with moderate-to-severe ARDS within 36 hours of fulfilling Berlin criteria will be evaluated.
Prior to randomization, the patient's recruitment potential will be measured bedside using the R/I ratio (where > 0.5 indicates high recruitment potential and <= 0.5 indicates low potential). Eligible participants will then be randomized 1:1 into two PEEP titration groups:
- PEEP titration targeted to achieve the best static compliance of the respiratory system.
- PEEP titration guided by transpulmonary pressure measured via an esophageal balloon to target a positive end-expiratory transpulmonary pressure.
Crucially, immediately before starting the specific PEEP titration protocol in either group, an identical, standardized lung recruitment maneuver will be performed. This maneuver is executed in pressure-controlled ventilation (PCV) with a control pressure of 15 cmH2O, I:E ratio of 1:1, FiO2 1.0, starting with PEEP 5 cmH2O and increasing by 5 cmH2O every 10 seconds up to PEEP 25 cmH2O, maintaining a maximum peak pressure limit of 40 cmH2O for exactly 1 minute.
Standard baseline ventilator parameters will follow protective ventilation targets: volume-controlled ventilation, tidal volume 6-8 mL/kg of predicted body weight, respiratory rate adjusted to keep pH 7.25-7.45, plateau pressure < 28 cmH2O, and driving pressure < 14 cmH2O. Physiological parameters (PaO2/FiO2, driving pressure, ventilatory ratio, static compliance) will be recorded at 1, 24, 48, and 72 hours. The primary outcome is the change in oxygenation (PaO2/FiO2 ratio) at 24 hours. The study will explore how the baseline phenotype of lung recruitability alters early mechanical and gas exchange outcomes.
- Being tested
- Positive End-Expiratory Pressure (PEEP) Titration guided by Static Compliance, Positive End-Expiratory Pressure (PEEP) Titration guided by Transpulmonary Pressure
- Keywords
- Acute Respiratory Distress Syndrome, Positive End-Expiratory Pressure, Respiratory Mechanics, Lung Volume Measurements, Esophageal Monitoring, Ventilator-Induced Lung Injury, Artificial Respiration
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive End-Expiratory Pressure (PEEP) Titration guided by Static ComplianceProcedure or surgery
Also called Initial Lung Recruitment Maneuver
Positive End-Expiratory Pressure (PEEP) Titration by Static Compliance: Following the initial recruitment maneuver, an individualized PEEP decremental titration step-protocol is performed to identify the specific PEEP level that maximizes the static compliance of the respiratory system, aiming to optimize the balance between alveolar recruitment and overdistension.
Initial Lung Recruitment Maneuver : Prior to individualized PEEP titration, all participants in this arm will undergo an initial standardized lung recruitment maneuver. This procedure will be executed in Pressure-Controlled Ventilation (PCV) mode, utilizing a driving/control pressure of 15 cmH2O. The recruitment process will begin at a baseline Positive End-Expiratory Pressure (PEEP) of 5 cmH2O, followed by incremental steps of 5 cmH2O every 10 seconds until reaching a maximum PEEP of 25 cmH2O. A peak airway pressure limit of 40 cmH2O will be strictly maintained during the maneuver for a total duration of 1 minute.
Positive End-Expiratory Pressure (PEEP) Titration guided by Transpulmonary PressureProcedure or surgery
Also called Initial Lung Recruitment Maneuver
Positive End-Expiratory Pressure (PEEP) Titration by Transpulmonary Pressure: Following the initial recruitment maneuver, PEEP is titrated and protocolized via real-time esophageal balloon monitoring to target and maintain a slightly positive expiratory transpulmonary pressure, minimizing cyclic alveolar collapse and overdistension.
Initial Lung Recruitment Maneuver: Prior to individualized PEEP titration, all participants in this arm will undergo an initial standardized lung recruitment maneuver. This procedure will be executed in Pressure-Controlled Ventilation (PCV) mode, utilizing a driving/control pressure of 15 cmH2O. The recruitment process will begin at a baseline Positive End-Expiratory Pressure (PEEP) of 5 cmH2O, followed by incremental steps of 5 cmH2O every 10 seconds until reaching a maximum PEEP of 25 cmH2O. A peak airway pressure limit of 40 cmH2O will be strictly maintained during the maneuver for a total duration of 1 minute.
| Study group | Role | What they receive |
|---|---|---|
| Best Static Compliance Titration | Experimental | Patients receive positive end-expiratory pressure (PEEP) titration guided by the best static compliance of the respiratory system after undergoing a standardized initial lung recruitment maneuver Receives: Procedure: Positive End-Expiratory Pressure (PEEP) Titration guided by Static Compliance |
| Transpulmonary Pressure Titration | Experimental | Patients receive positive end-expiratory pressure (PEEP) titration guided by transpulmonary pressure estimation via an esophageal balloon catheter after undergoing an identical standardized initial lung recruitment maneuver. Receives: Procedure: Positive End-Expiratory Pressure (PEEP) Titration guided by Transpulmonary Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Early Oxygenation (PaO2/FiO2 Ratio).
The change in gas exchange efficiency is calculated as the absolute difference between the baseline Partial pressure of oxygen in arterial blood (PaO2)/Fraction of inspired oxygen (FiO2) ratio and the PaO2/FiO2 ratio measured 24 hours after individualized Positive End-Expiratory Pressure (PEEP) titration.
Measured: Baseline and 24 hours post-PEEP titration
Secondary outcomes (6)
Evolution of Static Compliance of the Respiratory System
Changes in static compliance calculated via the formula: Tidal Volume / (Plateau Pressure - Positive End-Expiratory Pressure).
Measured: Baseline, 1, 24, 48, and 72 hours
Evolution of Driving Pressure and Plateau Pressure
Serial monitoring of driving pressure (Plateau Pressure - Positive End-Expiratory Pressure) and plateau pressure to evaluate lung stress.
Measured: Baseline, 1, 24, 48, and 72 hours
Ventilatory Efficiency
Evaluated using the Ventilatory Ratio (VR), which correlates physiological dead space and minute ventilation.
Measured: Baseline, 24, 48, and 72 hours
Incidence of Elevated Airway Opening Pressure (AOP)
Proportion of patients exhibiting an airway opening pressure greater than 5 cmH2O.
Measured: Pre-randomization (Baseline)
Ventilator-Free Days (VFD)
Number of days alive and free from invasive mechanical ventilation within a 28-day window.
Measured: Up to Day 28
Incidence of Procedure-Related Adverse Events
Proportion of participants experiencing complications due to recruitment maneuvers or Positive End-Expiratory Pressure (PEEP) titration (e.g., severe hypotension, barotrauma).
Measured: Throughout mechanical ventilation (Up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, parallel-group, open-label, exploratory clinical trial. Patients are stratified or analyzed according to their baseline lung recruitment potential (high vs. low, determined by the Recruitment/Inflation \[R/I\] ratio) and randomized to receive one of two early individualized Positive End-Expiratory Pressure (PEEP) titration strategies. Both arms undergo an identical initial lung recruitment maneuver prior to titration
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Dr. Franco Ravera Zunino
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francisco Cerda, RT., Study chair, Hospital Dr. Franco Ravera ZuninoJavier Astudillo, MD., Study chair, Hospital Dr. Franco Ravera ZuninoJennifer Ayuso, RT., Study chair, Hospital Dr. Franco Ravera ZuninoRodrigo Arevalo, RT., Study chair, Hospital Dr. Franco Ravera ZuninoCarlos Pellegrini, MD., Study chair, Hospital Dr. Franco Ravera ZuninoEsteban Santis, RT., Principal investigator, Hospital Dr. Franco Ravera Zunino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603310
- Sponsor's protocol ID
- HFRZ-UPC-2026-01
- Acronym
- RECRUIT-PEEP
- Status last verified
- Jul 2026
- First submitted
- 18 May 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) generated during this clinical trial will not be shared with other researchers due to ethical, legal, and privacy considerations. The study involves the collection of sensitive personal and health-related information. Furthermore, the informed consent process did not include provisions for unrestricted sharing of individual-level data with third parties. To ensure compliance with applicable data protection regulations and to safeguard participant confidentiality, only aggregated and anonymized study results will be made available through scientific publications, presentations, or upon reasonable request. These grouped data will provide sufficient information to support scientific transparency, interpretation of findings, and secondary analyses without compromising the privacy of participants
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Lung Recruitment Potential on the Response to Two Positive End-Expiratory Pressure (PEEP) Titration Strategies in Patients With Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT07603310
- Acronym / sponsor ID
- RECRUIT-PEEP / HFRZ-UPC-2026-01
- Keywords
- Acute Respiratory Distress Syndrome, Positive End-Expiratory Pressure, Respiratory Mechanics, Lung Volume Measurements, Esophageal Monitoring, Ventilator-Induced Lung Injury, Artificial Respiration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Hospital Dr. Franco Ravera ZuninoUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 22 May 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.
Acute Respiratory Distress Syndrome (ARDS) is characterized by severe hypoxemia and diffuse alveolar collapse, often requiring invasive mechanical ventilation. Non-individualized mechanical ventilation settings can cause ventilator-induced lung injury (VILI). Positive end-expiratory pressure (PEEP) prevents alveolar collapse, but its effect varies among individuals. The recruitment-to-inflation (R/I) ratio evaluates bedside lung recruitment potential. This pilot study aims to compare two individualized PEEP titration strategies-one guided by the best static respiratory compliance and another guided by transpulmonary pressure via an esophageal balloon-and evaluate how baseline lung recruitment potential alters the early physiological responses to these interventions. Both strategies are preceded by an identical, standardized pressure-controlled initial lung recruitment maneuver to establish a baseline recruitment state.
Detailed description
This is a prospective, randomized, open-label, parallel-group pilot study conducted at the Adult Intensive Care Unit of Hospital Dr. Franco Ravera Zunino (HFRZ). Eligible adult patients under invasive mechanical ventilation with moderate-to-severe ARDS within 36 hours of fulfilling Berlin criteria will be evaluated.
Prior to randomization, the patient's recruitment potential will be measured bedside using the R/I ratio (where > 0.5 indicates high recruitment potential and <= 0.5 indicates low potential). Eligible participants will then be randomized 1:1 into two PEEP titration groups:
- PEEP titration targeted to achieve the best static compliance of the respiratory system.
- PEEP titration guided by transpulmonary pressure measured via an esophageal balloon to target a positive end-expiratory transpulmonary pressure.
Crucially, immediately before starting the specific PEEP titration protocol in either group, an identical, standardized lung recruitment maneuver will be performed. This maneuver is executed in pressure-controlled ventilation (PCV) with a control pressure of 15 cmH2O, I:E ratio of 1:1, FiO2 1.0, starting with PEEP 5 cmH2O and increasing by 5 cmH2O every 10 seconds up to PEEP 25 cmH2O, maintaining a maximum peak pressure limit of 40 cmH2O for exactly 1 minute.
Standard baseline ventilator parameters will follow protective ventilation targets: volume-controlled ventilation, tidal volume 6-8 mL/kg of predicted body weight, respiratory rate adjusted to keep pH 7.25-7.45, plateau pressure < 28 cmH2O, and driving pressure < 14 cmH2O. Physiological parameters (PaO2/FiO2, driving pressure, ventilatory ratio, static compliance) will be recorded at 1, 24, 48, and 72 hours. The primary outcome is the change in oxygenation (PaO2/FiO2 ratio) at 24 hours. The study will explore how the baseline phenotype of lung recruitability alters early mechanical and gas exchange outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized, parallel-group, open-label, exploratory clinical trial. Patients are stratified or analyzed according to their baseline lung recruitment potential (high vs. low, determined by the Recruitment/Inflation [R/I] ratio) and randomized to receive one of two early individualized Positive End-Expiratory Pressure (PEEP) titration strategies. Both arms undergo an identical initial lung recruitment maneuver prior to titration
| Arm | Type | Receives |
|---|---|---|
| Best Static Compliance Titration | Experimental | Procedure: Positive End-Expiratory Pressure (PEEP) Titration guided by Static CompliancePatients receive positive end-expiratory pressure (PEEP) titration guided by the best static compliance of the respiratory system after undergoing a standardized initial lung recruitment maneuver |
| Transpulmonary Pressure Titration | Experimental | Procedure: Positive End-Expiratory Pressure (PEEP) Titration guided by Transpulmonary PressurePatients receive positive end-expiratory pressure (PEEP) titration guided by transpulmonary pressure estimation via an esophageal balloon catheter after undergoing an identical standardized initial lung recruitment maneuver. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of moderate or severe Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: acute onset, bilateral opacities not fully explained by heart failure or fluid overload, and Partial pressure of oxygen in arterial blood/Fraction of inspired oxygen <= 200 mmHg with Positive End-Expiratory Pressure (PEEP) >= 5 cmH2O.
- ARDS duration < 36 hours since fully meeting Berlin consensus criteria.
- Relative hemodynamic stability: absence of refractory shock, defined as norepinephrine dose <= 0.5 mcg/kg/min.
Key exclusion criteria (11 listed)
- Evidence of active pulmonary air leaks (bronchopleural fistula, pneumothorax, pneumomediastinum).
- Severe uncorrected hemodynamic instability (norepinephrine > 0.5 mcg/kg/min).
- Contraindications for esophageal balloon placement (esophageal obstruction, known perforation, recent esophageal surgery, severe esophagitis).
- Elevated intracranial pressure or conditions where hypercapnia-induced increases in intracranial pressure must be avoided (intracranial hemorrhage, cerebral contusion, cerebral edema, mass effect with midline shift on CT).
- Known pregnancy.
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 |
|---|---|---|
| Positive End-Expiratory Pressure (PEEP) Titration guided by Static ComplianceAlso: Initial Lung Recruitment ManeuverPositive End-Expiratory Pressure (PEEP) Titration by Static Compliance: Following the initial recruitment maneuver, an individualized PEEP decremental titration step-protocol is performed to identify the specific PEEP level that maximizes the static compliance of the respiratory system, aiming to optimize the balance between alveolar recruitment and overdistension. Initial Lung Recruitment Maneuver : Prior to individualized PEEP titration, all participants in this arm will undergo an initial standardized lung recruitment maneuver. This procedure will be executed in Pressure-Controlled Ventilation (PCV) mode, utilizing a driving/control pressure of 15 cmH2O. The recruitment process will begin at a baseline Positive End-Expiratory Pressure (PEEP) of 5 cmH2O, followed by incremental steps of 5 cmH2O every 10 seconds until reaching a maximum PEEP of 25 cmH2O. A peak airway pressure limit of 40 cmH2O will be strictly maintained during the maneuver for a total duration of 1 minute. | Procedure or surgery | Best Static Compliance Titration |
| Positive End-Expiratory Pressure (PEEP) Titration guided by Transpulmonary PressureAlso: Initial Lung Recruitment ManeuverPositive End-Expiratory Pressure (PEEP) Titration by Transpulmonary Pressure: Following the initial recruitment maneuver, PEEP is titrated and protocolized via real-time esophageal balloon monitoring to target and maintain a slightly positive expiratory transpulmonary pressure, minimizing cyclic alveolar collapse and overdistension. Initial Lung Recruitment Maneuver: Prior to individualized PEEP titration, all participants in this arm will undergo an initial standardized lung recruitment maneuver. This procedure will be executed in Pressure-Controlled Ventilation (PCV) mode, utilizing a driving/control pressure of 15 cmH2O. The recruitment process will begin at a baseline Positive End-Expiratory Pressure (PEEP) of 5 cmH2O, followed by incremental steps of 5 cmH2O every 10 seconds until reaching a maximum PEEP of 25 cmH2O. A peak airway pressure limit of 40 cmH2O will be strictly maintained during the maneuver for a total duration of 1 minute. | Procedure or surgery | Transpulmonary Pressure Titration |
Primary outcome
Change in Early Oxygenation (PaO2/FiO2 Ratio).
Time frame: Baseline and 24 hours post-PEEP titration
The change in gas exchange efficiency is calculated as the absolute difference between the baseline Partial pressure of oxygen in arterial blood (PaO2)/Fraction of inspired oxygen (FiO2) ratio and the PaO2/FiO2 ratio measured 24 hours after individualized Positive End-Expiratory Pressure (PEEP) titration.
6 secondary outcomes
Evolution of Static Compliance of the Respiratory System
Time frame: Baseline, 1, 24, 48, and 72 hours
Evolution of Driving Pressure and Plateau Pressure
Time frame: Baseline, 1, 24, 48, and 72 hours
Ventilatory Efficiency
Time frame: Baseline, 24, 48, and 72 hours
Incidence of Elevated Airway Opening Pressure (AOP)
Time frame: Pre-randomization (Baseline)
Ventilator-Free Days (VFD)
Time frame: Up to Day 28
Incidence of Procedure-Related Adverse Events
Time frame: Throughout mechanical ventilation (Up to 28 days)
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 10 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) generated during this clinical trial will not be shared with other researchers due to ethical, legal, and privacy considerations. The study involves the collection of sensitive personal and health-related information. Furthermore, the informed consent process did not include provisions for unrestricted sharing of individual-level data with third parties. To ensure compliance with applicable data protection regulations and to safeguard participant confidentiality, only aggregated and anonymized study results will be made available through scientific publications, presentations, or upon reasonable request. These grouped data will provide sufficient information to support scientific transparency, interpretation of findings, and secondary analyses without compromising the privacy of participants
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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.
Francisco Cerda, RT. study chair
Hospital Dr. Franco Ravera Zunino
Javier Astudillo, MD. study chair
Hospital Dr. Franco Ravera Zunino
Jennifer Ayuso, RT. study chair
Hospital Dr. Franco Ravera Zunino
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive End-Expiratory Pressure (PEEP) Titration guided by Static Compliance and Positive End-Expiratory Pressure (PEEP) Titration guided by Transpulmonary Pressure in people with ARDS (Acute Respiratory Distress Syndrome), run by Hospital Dr. Franco Ravera Zunino at 1 site in Chile.
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 3 inclusion and 11 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 10 Jul 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 Chile. 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 Esteban Santis, RT. (940367716 ext. +56, esteban.santis@ogb.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Early Oxygenation (PaO2/FiO2 Ratio). (time frame: Baseline and 24 hours post-PEEP titration). 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 10 Jul 2026.