Mechanical VentilationPEEP-EFFORTNCT07437846
Impact of PEEP on Respiratory Effort During Assisted Ventilation
A study testing PEEP Level Adjustment in people with Mechanical Ventilation and Respiratory Failure, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Assisted mechanical ventilation is widely used to preserve diaphragmatic activity and improve lung aeration in patients with acute respiratory failure. However, during assisted ventilation, excessive inspiratory effort may develop and contribute to lung injury, diaphragmatic overload, and patient self-inflicted lung… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Respiratory Failure, Effort
- What is being tested?
- PEEP Level Adjustment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChile
- Study dates
- 1 Jan 2025to Jul 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 ≥18 years.
- ICU patients receiving invasive mechanical ventilation (endotracheal tube or tracheostomy).
- Ventilated in an assisted mode with spontaneous breathing
- Clinically stable to undergo protocolized PEEP changes.
- Sedation level compatible with spontaneous breathing and ventilator triggering
- Informed consent from the patient or legally authorized representative.
Who cannot join
- Contraindication to esophageal balloon placement (if applicable).
- Significant hemodynamic instability or unstable vasopressor requirements.
- Unstable arrhythmia or active myocardial ischemia.
- Undrained pneumothorax or major air leak.
- Controlled ventilation without effective spontaneous effort (apnea, neuromuscular blockade, deep sedation).
- Pregnancy
- Acute or chronic neurological conditions that may impair respiratory drive or interfere with the regulation of spontaneous breathing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Felipe Damiani, PhD, Msc, Physioterapy contact
Chile1 site, 1 recruiting
- Recruiting
Hospital Clinico UC
Santiago, Santiago Metropolitan
Diego Lopez Arnello, Physioterapy, 973805897, diegon.lopez@uc.cl
Roque Basoalto, PhD, Msc, Physioterapy, +56 9 8446 3575, roque.basoalto@gmail.com
About this study
Official title: Impact of Positive End-Expiratory Pressure on the Modulation of Respiratory Effort During Assisted Ventilation: A Physiological Randomized Crossover Study
Assisted mechanical ventilation is widely used to preserve diaphragmatic activity and improve lung aeration in patients with acute respiratory failure. However, during assisted ventilation, excessive inspiratory effort may develop and contribute to lung injury, diaphragmatic overload, and patient self-inflicted lung injury.
Optimizing ventilator settings to modulate respiratory effort therefore represents a major physiological and clinical challenge.
Read more
Positive end-expiratory pressure (PEEP) is a key determinant of lung recruitment and respiratory system mechanics and may influence inspiratory effort by modifying lung volume, compliance, and respiratory drive. Despite its widespread use, PEEP titration in clinical practice is still mainly guided by oxygenation parameters, while its direct effects on inspiratory effort during assisted mechanical ventilation remain insufficiently characterized.
This physiological randomized crossover study aims to evaluate the effect of four predefined levels of positive end-expiratory pressure (0, 5, 10, and 15 cmH₂O) on the respiratory system and inspiratory effort in adult patients receiving assisted mechanical ventilation. Patients will be exposed to each PEEP level in randomized order, with stabilization and washout periods between conditions, while ventilatory support settings other than PEEP are kept constant.
- Conditions
- Mechanical Ventilation, Respiratory Failure, Effort
- Being tested
- PEEP Level Adjustment
- Keywords
- Assisted mechanical ventilation, Inspiratory Effort, Breathing effort
- Medical subject headings
- Respiratory Insufficiency, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP Level AdjustmentOther
Also called PEEP levels
Positive end-expiratory pressure (PEEP) will be adjusted to four predefined levels (0, 5, 10, and 15 cmH₂O) following a randomized crossover protocol during assisted mechanical ventilation. Only the PEEP level will be modified, while all other ventilator settings will be kept constant. Each PEEP level will be maintained for 15 minutes, followed by a 15-minute washout period between levels. Physiological measurements will be obtained during the last 5 minutes of each PEEP level, including respiratory effort assessed using invasive and non-invasive methods, respiratory mechanics, and hemodynamic parameters.
| Study group | Role | What they receive |
|---|---|---|
| PEEP 0 cmH₂O | Experimental | Participants are ventilated with a positive end-expiratory pressure of 0 cmH₂O during assisted mechanical ventilation. Physiological measurements of respiratory effort are obtained during a predefined stabilization period according to the study protocol. Receives: Other: PEEP Level Adjustment |
| PEEP 5 cmH₂O | Experimental | Participants are ventilated with a positive end-expiratory pressure of 5 cmH₂O during assisted mechanical ventilation. Physiological measurements of respiratory effort are obtained during a predefined stabilization period according to the study protocol. Receives: Other: PEEP Level Adjustment |
| PEEP 10 cmH₂O | Experimental | Participants are ventilated with a positive end-expiratory pressure of 10 cmH₂O during assisted mechanical ventilation. Physiological measurements of respiratory effort are obtained during a predefined stabilization period according to the study protocol. Receives: Other: PEEP Level Adjustment |
| PEEP 15 cmH₂O | Experimental | Participants are ventilated with a positive end-expiratory pressure of 15 cmH₂O during assisted mechanical ventilation. Physiological measurements of respiratory effort are obtained during a predefined stabilization period according to the study protocol. Receives: Other: PEEP Level Adjustment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Esophageal pressure swing (ΔPes)
Esophageal pressure swing (ΔPes), defined as the absolute difference between end-expiratory and end-inspiratory esophageal pressure, measured using an esophageal balloon catheter.
Measured: During the last 5 minutes of each PEEP level
Pressure-time product per minute (PTPmin)
Pressure-time product per minute (PTPmin), expressed as cmH₂O·s/min, measured using an esophageal balloon catheter as an index of global inspiratory effort.
Measured: During the last 5 minutes of each PEEP level
Delta Pocc (ΔPocc)
Airway occlusion pressure-derived index (ΔPocc) obtained from brief ventilator-based airway occlusion maneuvers as a non-invasive measurement of inspiratory effort.
Measured: During the last 5 minutes of each PEEP level
Muscular Pressure Index (PMI)
Muscular Pressure Index (PMI) calculated from ventilator-based airway occlusion maneuvers as a non-invasive estimate of inspiratory muscle pressure.
Measured: During the last 5 minutes of each PEEP level
Secondary outcomes (7)
Airway occlusion pressure at 100 ms (P0.1)
Airway occlusion pressure at 100 milliseconds (P0.1), measured by the mechanical ventilator as an index of respiratory drive.
Measured: During the last 5 minutes of each PEEP level
Respiratory system compliance (Cest)
Static compliance of the respiratory system (Cest) measured during assisted mechanical ventilation at each PEEP level.
Measured: During the last 5 minutes of each PEEP level
Driving pressure
Driving pressure calculated as the difference between airway plateau pressure and total PEEP during assisted mechanical ventilation at each PEEP level.
Measured: During the last 5 minutes of each PEEP level
Plateau pressure
Airway plateau pressure measured during assisted mechanical ventilation at each PEEP level.
Measured: During the last 5 minutes of each PEEP level
Hemodynamic response
Hemodynamic response assessed using heart rate, arterial blood pressure, respiratory rate and oxygen saturation during assisted mechanical ventilation at different PEEP levels.
Measured: During the last 5 minutes of each PEEP level
Gas exchange (SaFi index)
Gas exchange assessed using the SaFi index (SpO₂/FiO₂ ratio) at each PEEP level.
Measured: During the last 5 minutes of each PEEP level
Dynamic transpulmonary pressure
ynamic transpulmonary pressure calculated during assisted mechanical ventilation using airway pressure and esophageal pressure measurements obtained with an esophageal balloon catheter.
Measured: During the last 5 minutes of each PEEP level
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jan 2025
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (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 Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- After informed consent is obtained, participants admitted to the ICU of Hospital Clínico UC or Clínica Universidad de los Andes and receiving invasive mechanical ventilation will undergo a randomized physiological crossover intervention. Pressure support will remain unchanged throughout the study and will be maintained at the level programmed by the treating medical team prior to study initiation. Four predefined levels of positive end-expiratory pressure (PEEP: 0, 5, 10, and 15 cmH₂O) will be applied in a randomized sequence, each lasting 15 minutes. Between each PEEP level, a 15-minute washout period will be performed using the same PEEP level set by the treating medical team before the intervention. During the final 5 minutes of each PEEP stage, physiological measurements of respiratory effort will be recorded. If clinical instability occurs, the intervention will be stopped and ventilator settings will be returned to baseline.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Clínica Universidad de los Andes
- Responsible party
- Sponsor
- Investigators
- Roque Basoalto, PhD, Msc, Physioterapy, Principal investigator, Pontifica Universidad Catolica de ChileSebastian Morales, Physician, Study chair, Pontifica Universidad Catolica de ChileAlejandro Bruh Bruhn, Principal investigator, Pontifica Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437846
- Sponsor's protocol ID
- 240206001
- Acronym
- PEEP-EFFORT
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morais CCA, Koyama Y, Yoshida T, Plens GM, Gomes S, Lima CAS, Ramos OPS, Pereira SM, Kawaguchi N, Yamamoto H, Uchiyama A, Borges JB, Vidal Melo MF, Tucci MR, Amato MBP, Kavanagh BP, Costa ELV, Fujino Y. High Positive End-Expiratory Pressure Renders Spontaneous Effort Noninjurious. Am J Respir Crit Care Med. 2018 May 15;197(10):1285-1296. doi: 10.1164/rccm.201706-1244OC.
PubMed 29323536Foti G, Cereda M, Banfi G, Pelosi P, Fumagalli R, Pesenti A. End-inspiratory airway occlusion: a method to assess the pressure developed by inspiratory muscles in patients with acute lung injury undergoing pressure support. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 1):1210-6. doi: 10.1164/ajrccm.156.4.96-02031.
PubMed 9351624Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
PubMed 27334266Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.
PubMed 32516052Bello G, Giammatteo V, Bisanti A, Delle Cese L, Rosa T, Menga LS, Montini L, Michi T, Spinazzola G, De Pascale G, Pennisi MA, Ribeiro De Santis Santiago R, Berra L, Antonelli M, Grieco DL. High vs Low PEEP in Patients With ARDS Exhibiting Intense Inspiratory Effort During Assisted Ventilation: A Randomized Crossover Trial. Chest. 2024 Jun;165(6):1392-1405. doi: 10.1016/j.chest.2024.01.040. Epub 2024 Jan 29.
PubMed 38295949
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Positive End-Expiratory Pressure on the Modulation of Respiratory Effort During Assisted Ventilation: A Physiological Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT07437846
- Acronym / sponsor ID
- PEEP-EFFORT / 240206001
- Conditions
- Mechanical Ventilation, Respiratory Failure, Effort
- Keywords
- Assisted mechanical ventilation, Inspiratory Effort, Breathing effort
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Clínica Universidad de los Andes
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 27 Feb 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.
Assisted mechanical ventilation is widely used to preserve diaphragmatic activity and improve lung aeration in patients with acute respiratory failure. However, during assisted ventilation, excessive inspiratory effort may develop and contribute to lung injury, diaphragmatic overload, and patient self-inflicted lung injury.
Optimizing ventilator settings to modulate respiratory effort therefore represents a major physiological and clinical challenge.
Positive end-expiratory pressure (PEEP) is a key determinant of lung recruitment and respiratory system mechanics and may influence inspiratory effort by modifying lung volume, compliance, and respiratory drive. Despite its widespread use, PEEP titration in clinical practice is still mainly guided by oxygenation parameters, while its direct effects on inspiratory effort during assisted mechanical ventilation remain insufficiently characterized.
This physiological randomized crossover study aims to evaluate the effect of four predefined levels of positive end-expiratory pressure (0, 5, 10, and 15 cmH₂O) on the respiratory system and inspiratory effort in adult patients receiving assisted mechanical ventilation. Patients will be exposed to each PEEP level in randomized order, with stabilization and washout periods between conditions, while ventilatory support settings other than PEEP are kept constant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- After informed consent is obtained, participants admitted to the ICU of Hospital Clínico UC or Clínica Universidad de los Andes and receiving invasive mechanical ventilation will undergo a randomized physiological crossover intervention. Pressure support will remain unchanged throughout the study and will be maintained at the level programmed by the treating medical team prior to study initiation. Four predefined levels of positive end-expiratory pressure (PEEP: 0, 5, 10, and 15 cmH₂O) will be applied in a randomized sequence, each lasting 15 minutes. Between each PEEP level, a 15-minute washout period will be performed using the same PEEP level set by the treating medical team before the intervention. During the final 5 minutes of each PEEP stage, physiological measurements of respiratory effort will be recorded. If clinical instability occurs, the intervention will be stopped and ventilator settings will be returned to baseline.
| Arm | Type | Receives |
|---|---|---|
| PEEP 0 cmH₂O | Experimental | Other: PEEP Level AdjustmentParticipants are ventilated with a positive end-expiratory pressure of 0 cmH₂O during assisted mechanical ventilation. Physiological measurements of respiratory effort are obtained during a predefined stabilization period according to the study protocol. |
| PEEP 5 cmH₂O | Experimental | Other: PEEP Level AdjustmentParticipants are ventilated with a positive end-expiratory pressure of 5 cmH₂O during assisted mechanical ventilation. Physiological measurements of respiratory effort are obtained during a predefined stabilization period according to the study protocol. |
| PEEP 10 cmH₂O | Experimental | Other: PEEP Level AdjustmentParticipants are ventilated with a positive end-expiratory pressure of 10 cmH₂O during assisted mechanical ventilation. Physiological measurements of respiratory effort are obtained during a predefined stabilization period according to the study protocol. |
| PEEP 15 cmH₂O | Experimental | Other: PEEP Level AdjustmentParticipants are ventilated with a positive end-expiratory pressure of 15 cmH₂O during assisted mechanical ventilation. Physiological measurements of respiratory effort are obtained during a predefined stabilization period according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- ICU patients receiving invasive mechanical ventilation (endotracheal tube or tracheostomy).
- Ventilated in an assisted mode with spontaneous breathing
- Clinically stable to undergo protocolized PEEP changes.
- Sedation level compatible with spontaneous breathing and ventilator triggering
Key exclusion criteria (7 listed)
- Contraindication to esophageal balloon placement (if applicable).
- Significant hemodynamic instability or unstable vasopressor requirements.
- Unstable arrhythmia or active myocardial ischemia.
- Undrained pneumothorax or major air leak.
- Controlled ventilation without effective spontaneous effort (apnea, neuromuscular blockade, deep sedation).
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 |
|---|---|---|
| PEEP Level AdjustmentAlso: PEEP levelsPositive end-expiratory pressure (PEEP) will be adjusted to four predefined levels (0, 5, 10, and 15 cmH₂O) following a randomized crossover protocol during assisted mechanical ventilation. Only the PEEP level will be modified, while all other ventilator settings will be kept constant. Each PEEP level will be maintained for 15 minutes, followed by a 15-minute washout period between levels. Physiological measurements will be obtained during the last 5 minutes of each PEEP level, including respiratory effort assessed using invasive and non-invasive methods, respiratory mechanics, and hemodynamic parameters. | Other | PEEP 0 cmH₂O, PEEP 10 cmH₂O, PEEP 15 cmH₂O, PEEP 5 cmH₂O |
Primary outcome
Esophageal pressure swing (ΔPes)
Time frame: During the last 5 minutes of each PEEP level
Esophageal pressure swing (ΔPes), defined as the absolute difference between end-expiratory and end-inspiratory esophageal pressure, measured using an esophageal balloon catheter.
Pressure-time product per minute (PTPmin)
Time frame: During the last 5 minutes of each PEEP level
Pressure-time product per minute (PTPmin), expressed as cmH₂O·s/min, measured using an esophageal balloon catheter as an index of global inspiratory effort.
Delta Pocc (ΔPocc)
Time frame: During the last 5 minutes of each PEEP level
Airway occlusion pressure-derived index (ΔPocc) obtained from brief ventilator-based airway occlusion maneuvers as a non-invasive measurement of inspiratory effort.
Muscular Pressure Index (PMI)
Time frame: During the last 5 minutes of each PEEP level
Muscular Pressure Index (PMI) calculated from ventilator-based airway occlusion maneuvers as a non-invasive estimate of inspiratory muscle pressure.
7 secondary outcomes
Airway occlusion pressure at 100 ms (P0.1)
Time frame: During the last 5 minutes of each PEEP level
Respiratory system compliance (Cest)
Time frame: During the last 5 minutes of each PEEP level
Driving pressure
Time frame: During the last 5 minutes of each PEEP level
Plateau pressure
Time frame: During the last 5 minutes of each PEEP level
Hemodynamic response
Time frame: During the last 5 minutes of each PEEP level
Gas exchange (SaFi index)
Time frame: During the last 5 minutes of each PEEP level
Dynamic transpulmonary pressure
Time frame: During the last 5 minutes of each PEEP level
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 27 Feb 2026.
- Background: PubMed 29323536Morais CCA, Koyama Y, Yoshida T, Plens GM, Gomes S, Lima CAS, Ramos OPS, Pereira SM, Kawaguchi N, Yamamoto H, Uchiyama A, Borges JB, Vidal Melo MF, Tucci MR, Amato MBP, Kavanagh BP, Costa ELV, Fujino Y. High Positive End-Expiratory Pressure Renders Spontaneous Effort Noninjurious. Am J Respir Crit Care Med. 2018 May 15;197(10):1285-1296. doi: 10.1164/rccm.201706-1244OC.
- Background: PubMed 9351624Foti G, Cereda M, Banfi G, Pelosi P, Fumagalli R, Pesenti A. End-inspiratory airway occlusion: a method to assess the pressure developed by inspiratory muscles in patients with acute lung injury undergoing pressure support. Am J Respir Crit Care Med. 1997 Oct;156(4 Pt 1):1210-6. doi: 10.1164/ajrccm.156.4.96-02031.
- Background: PubMed 27334266Mauri T, Yoshida T, Bellani G, Goligher EC, Carteaux G, Rittayamai N, Mojoli F, Chiumello D, Piquilloud L, Grasso S, Jubran A, Laghi F, Magder S, Pesenti A, Loring S, Gattinoni L, Talmor D, Blanch L, Amato M, Chen L, Brochard L, Mancebo J; PLeUral pressure working Group (PLUG-Acute Respiratory Failure section of the European Society of Intensive Care Medicine). Esophageal and transpulmonary pressure in the clinical setting: meaning, usefulness and perspectives. Intensive Care Med. 2016 Sep;42(9):1360-73. doi: 10.1007/s00134-016-4400-x. Epub 2016 Jun 22.
- Background: PubMed 32516052Goligher EC, Dres M, Patel BK, Sahetya SK, Beitler JR, Telias I, Yoshida T, Vaporidi K, Grieco DL, Schepens T, Grasselli G, Spadaro S, Dianti J, Amato M, Bellani G, Demoule A, Fan E, Ferguson ND, Georgopoulos D, Guerin C, Khemani RG, Laghi F, Mercat A, Mojoli F, Ottenheijm CAC, Jaber S, Heunks L, Mancebo J, Mauri T, Pesenti A, Brochard L. Lung- and Diaphragm-Protective Ventilation. Am J Respir Crit Care Med. 2020 Oct 1;202(7):950-961. doi: 10.1164/rccm.202003-0655CP.
- Background: PubMed 38295949Bello G, Giammatteo V, Bisanti A, Delle Cese L, Rosa T, Menga LS, Montini L, Michi T, Spinazzola G, De Pascale G, Pennisi MA, Ribeiro De Santis Santiago R, Berra L, Antonelli M, Grieco DL. High vs Low PEEP in Patients With ARDS Exhibiting Intense Inspiratory Effort During Assisted Ventilation: A Randomized Crossover Trial. Chest. 2024 Jun;165(6):1392-1405. doi: 10.1016/j.chest.2024.01.040. Epub 2024 Jan 29.
- Individual participant dataSharing planned: No
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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.
Felipe Damiani, PhD, Msc, Physioterapy contact
Roque Basoalto, PhD, Msc, Physioterapy principal investigator
Pontifica Universidad Catolica de Chile
Sebastian Morales, Physician study chair
Pontifica Universidad Catolica de Chile
Alejandro Bruh Bruhn principal investigator
Pontifica Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP Level Adjustment in people with Mechanical Ventilation and Respiratory Failure, run by Pontificia Universidad Catolica de Chile 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 6 inclusion and 7 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 27 Feb 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 Diego Lopez Arnello, Physioterapy (+56973805897, diegon.lopez@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Esophageal pressure swing (ΔPes) (time frame: During the last 5 minutes of each PEEP level). The study lists 4 primary outcomes in all. 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 NCT07437846, 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 27 Feb 2026.