Pediatric Acute Respiratory Distress Syndrome (PARDS)NCT07750288
Role of Dyspnea in the Progression of Pediatric Acute Respiratory Distress Syndrome
An observational study of Pediatric Acute Respiratory Distress Syndrome (PARDS), run by Universidad Nacional Andres Bello at 1 site in Chile.
Trial summary
Pediatric acute respiratory distress syndrome (ARDS) is a life-threatening clinical syndrome, and dyspnea is its key symptom. Strenuous respiratory effort is a "second hit" for ARDS lungs, inducing changes in regional lung aeration and amplifying lung damage in preclinical studies, a phenomenon known as "patient… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Pediatric Acute Respiratory Distress Syndrome (PARDS)
- What is being tested?
- Noninvasive respiratory support and Weaning from mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteChile
- Study dates
- 13 Jul 2026to 31 Mar 2030
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children younger than 18 years old with a diagnosis of pediatric ARDS,
Who may be able to join
- Children younger than 18 years old.
- Diagnosis of pediatric ARDS, as defined by the 2023 Pediatric Acute Lung Injury Consensus Conference (PALICC2).
- Consent to participate given by legal guardians.
Who cannot join
- Tracheostomy.
- Neuromuscular disease.
- Uncorrected congenital heart disease.
- Contraindication to esophageal catheter (choanal atresia, esophageal issues, recent esophageal surgery, etc.) or EIT (pacemakers, defibrillators, and unstable fractures).
- Emergency intubation.
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
Hospital El Carmen Dr. Luis Valentin Ferrada
Santiago
Pablo Cruces, MD, (56)2266120638, pablo.cruces@unab.cl
About this study
Pediatric acute respiratory distress syndrome (ARDS) is a life-threatening clinical syndrome, and dyspnea is its key symptom. Strenuous respiratory effort is a "second hit" for ARDS lungs, inducing changes in regional lung aeration and amplifying lung damage in preclinical studies, a phenomenon known as "patient self-inflicted lung injury". In a clinical setting, clinicians are concerned about the possible connection between dyspnea and ARDS progression based on indirect evidence, such as the worse outcomes associated with delayed intubation or failed weaning from mechanical ventilation. Dyspnea is hard to quantify due to its subjective nature. Still, it can be assessed through its interrelated and independent components: respiratory drive (neural stimuli), respiratory effort (muscle contraction), and work of breathing (energy expenditure).
This project aims to identify mechanical thresholds of dyspnea components to predict early ARDS progression and outcome. The role of respiratory effort is particularly relevant in three phases of ARDS where a transition between spontaneous and controlled ventilation occurs: 1) acute phase, when clinicians try to prevent mechanical ventilation (MV) through non-invasive support; 2) intermediate phase, transitioning from controlled to assisted MV; and 3) late phase, during weaning from MV. These transitions are challenging because it is difficult for clinicians to titrate adequate support and avoid both under- and over-assistance.
Read more
In critically ill children, there are no established thresholds for dyspnea components that predict ARDS progression, and it remains unknown whether regional changes in lung aeration can anticipate this clinical deterioration. This is particularly relevant because the oxygenation decline signals that ARDS progression has already occurred, leading to a less reversible condition.
The investigators will use and integrate advanced respiratory monitoring tools to quantify these components, including surface electromyography, occlusion maneuvers, and esophageal manometry. Additionally, electrical impedance tomography, recently adapted for pediatric use, will be employed to detect early changes in regional aeration. All of these tools are gold standards for each parameter and allow real-time, bedside measurements without adding invasiveness to usual care.
To test the hypothesis, the investigators will quantify respiratory drive, effort, work of breathing, and regional lung aeration throughout all transitional phases of pediatric ARDS. In the acute phase, drive will be assessed via spectral analysis of surface electromyography, and in intermediate and late phases, via airway occlusion pressure at 100 ms. Esophageal manometry will be used to measure effort (swings of esophageal pressure) and work of breathing (pressure-time product). Changes in regional aeration (overstretching, collapse, and heterogeneity) will be assessed using electrical impedance tomography.
The investigators will define mechanical thresholds and cut-off points for each dyspnea component that predict early ARDS progression and outcomes at each transitional phase. Based on the study results, the investigators envision the future development of algorithms to help guide safer transitions between spontaneous and controlled ventilation, to improve outcomes, and prevent residual morbidity. The interdisciplinary team of clinicians and biomedical engineers will work to customize respiratory care in critically ill children, optimizing ventilatory assistance across disease stages.
- Being tested
- Noninvasive respiratory support, Transition from controlled to assisted mechanical ventilation, Weaning from mechanical ventilation
- Keywords
- respiratory effort, monitoring, surface electromyography, esophageal manometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive respiratory supportDevice
sEMG of respiratory muscles, esophageal manometry, and electrical impedance tomography
Transition from controlled to assisted mechanical ventilationDevice
sEMG of respiratory muscles, esophageal monitoring, and electrical impedance tomography
Weaning from mechanical ventilationDevice
sEMG of respiratory muscles, esophageal monitoring, and electrical impedance tomography
| Study group | Role | What they receive |
|---|---|---|
| PARDS/acute phase | PARDS patients under noninvasive respiratory support Receives: Device: Noninvasive respiratory support | |
| PARDS/intermediate phase | Transition from controlled to assisted MV Receives: Device: Transition from controlled to assisted mechanical ventilation | |
| PARDS/ late phase | Weaning from MV Receives: Device: Weaning from mechanical ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or Failure of the Intervention
Oxygenation decline (20% drop from baseline) or clinical signs of ventilatory overload. The outcome of the intervention will be determined by the attending physician. Measurements derived from the use of advanced respiratory monitoring tools will not be used to define the clinical outcome.
Measured: From enrollment to the end of respiratory support, with a maximal follow-up of 30 days.
Secondary outcomes (2)
Early changes in regional lung aeration, perfusion, or ventilation/perfusion mismatch
Assesed by electrical impedance tomography
Measured: From enrollment to the end of the respiratory support, with a maximal follow-up of 30 days.
Ventilator-free days
Measured: From enrollment to the end of respiratory support, with a maximal follow-up of 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start13 Jul 2026
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Acute Respiratory Distress Syndrome (PARDS)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Andres Bello
- Sponsor type
- University, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile, Universidad de los Andes, Chile
- Responsible party
- Principal investigator, Pablo Cruces, Universidad Nacional Andres Bello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750288
- Sponsor's protocol ID
- Fondecyt1260263
- Other IDs
- Fondecyt 1260263
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized and encrypted records of advanced pulmonary function monitoring could be shared with other research groups whose main research lines are PARDS/ respiratory effort/ mechanical ventilation.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Dyspnea in the Progression of Pediatric Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07750288
- Acronym / sponsor ID
- Fondecyt1260263
- Keywords
- respiratory effort, monitoring, surface electromyography, esophageal manometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Universidad Nacional Andres BelloUniversity, hospital or other
- Collaborators
- Pontificia Universidad Catolica de Chile, Universidad de los Andes, Chile
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 6 Aug 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.
Pediatric acute respiratory distress syndrome (ARDS) is a life-threatening clinical syndrome, and dyspnea is its key symptom. Strenuous respiratory effort is a "second hit" for ARDS lungs, inducing changes in regional lung aeration and amplifying lung damage in preclinical studies, a phenomenon known as "patient self-inflicted lung injury". In a clinical setting, clinicians are concerned about the possible connection between dyspnea and ARDS progression based on indirect evidence, such as the worse outcomes associated with delayed intubation or failed weaning from mechanical ventilation. Dyspnea is hard to quantify due to its subjective nature. Still, it can be assessed through its interrelated and independent components: respiratory drive (neural stimuli), respiratory effort (muscle contraction), and work of breathing (energy expenditure).
This project aims to identify mechanical thresholds of dyspnea components to predict early ARDS progression and outcome. The role of respiratory effort is particularly relevant in three phases of ARDS where a transition between spontaneous and controlled ventilation occurs: 1) acute phase, when clinicians try to prevent mechanical ventilation (MV) through non-invasive support; 2) intermediate phase, transitioning from controlled to assisted MV; and 3) late phase, during weaning from MV. These transitions are challenging because it is difficult for clinicians to titrate adequate support and avoid both under- and over-assistance.
In critically ill children, there are no established thresholds for dyspnea components that predict ARDS progression, and it remains unknown whether regional changes in lung aeration can anticipate this clinical deterioration. This is particularly relevant because the oxygenation decline signals that ARDS progression has already occurred, leading to a less reversible condition.
The investigators will use and integrate advanced respiratory monitoring tools to quantify these components, including surface electromyography, occlusion maneuvers, and esophageal manometry. Additionally, electrical impedance tomography, recently adapted for pediatric use, will be employed to detect early changes in regional aeration. All of these tools are gold standards for each parameter and allow real-time, bedside measurements without adding invasiveness to usual care.
To test the hypothesis, the investigators will quantify respiratory drive, effort, work of breathing, and regional lung aeration throughout all transitional phases of pediatric ARDS. In the acute phase, drive will be assessed via spectral analysis of surface electromyography, and in intermediate and late phases, via airway occlusion pressure at 100 ms. Esophageal manometry will be used to measure effort (swings of esophageal pressure) and work of breathing (pressure-time product). Changes in regional aeration (overstretching, collapse, and heterogeneity) will be assessed using electrical impedance tomography.
The investigators will define mechanical thresholds and cut-off points for each dyspnea component that predict early ARDS progression and outcomes at each transitional phase. Based on the study results, the investigators envision the future development of algorithms to help guide safer transitions between spontaneous and controlled ventilation, to improve outcomes, and prevent residual morbidity. The interdisciplinary team of clinicians and biomedical engineers will work to customize respiratory care in critically ill children, optimizing ventilatory assistance across disease stages.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PARDS/acute phase | – | Device: Noninvasive respiratory supportPARDS patients under noninvasive respiratory support |
| PARDS/intermediate phase | – | Device: Transition from controlled to assisted mechanical ventilationTransition from controlled to assisted MV |
| PARDS/ late phase | – | Device: Weaning from mechanical ventilationWeaning from MV |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children younger than 18 years old with a diagnosis of pediatric ARDS,
Key inclusion criteria (3 listed)
- Children younger than 18 years old.
- Diagnosis of pediatric ARDS, as defined by the 2023 Pediatric Acute Lung Injury Consensus Conference (PALICC2).
- Consent to participate given by legal guardians.
Key exclusion criteria (5 listed)
- Tracheostomy.
- Neuromuscular disease.
- Uncorrected congenital heart disease.
- Contraindication to esophageal catheter (choanal atresia, esophageal issues, recent esophageal surgery, etc.) or EIT (pacemakers, defibrillators, and unstable fractures).
- Emergency intubation.
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 |
|---|---|---|
| Noninvasive respiratory supportsEMG of respiratory muscles, esophageal manometry, and electrical impedance tomography | Device | PARDS/acute phase |
| Transition from controlled to assisted mechanical ventilationsEMG of respiratory muscles, esophageal monitoring, and electrical impedance tomography | Device | PARDS/intermediate phase |
| Weaning from mechanical ventilationsEMG of respiratory muscles, esophageal monitoring, and electrical impedance tomography | Device | PARDS/ late phase |
Primary outcome
Success or Failure of the Intervention
Time frame: From enrollment to the end of respiratory support, with a maximal follow-up of 30 days.
Oxygenation decline (20% drop from baseline) or clinical signs of ventilatory overload. The outcome of the intervention will be determined by the attending physician. Measurements derived from the use of advanced respiratory monitoring tools will not be used to define the clinical outcome.
2 secondary outcomes
Early changes in regional lung aeration, perfusion, or ventilation/perfusion mismatch
Time frame: From enrollment to the end of the respiratory support, with a maximal follow-up of 30 days.
Ventilator-free days
Time frame: From enrollment to the end of respiratory support, with a maximal follow-up of 30 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 1 Sep 2026.
- Individual participant dataSharing planned: Yes. Anonymized and encrypted records of advanced pulmonary function monitoring could be shared with other research groups whose main research lines are PARDS/ respiratory effort/ mechanical ventilation.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Acute Respiratory Distress Syndrome (PARDS), run by Universidad Nacional Andres Bello 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 5 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 1 Sep 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 Pablo Cruces, Full Professor ((56)990200810, pablo.cruces@unab.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success or Failure of the Intervention (time frame: From enrollment to the end of respiratory support, with a maximal follow-up of 30 days.). 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 1 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.