An observational study in Pediatric Acute Respiratory Distress Syndrome (PARDS), sponsored by Universidad Nacional Andres Bello. Recruiting at 1 site in Chile. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Universidad Nacional Andres Bello · Observational
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.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's planned enrollment of 68 is below the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Universidad Nacional Andres Bello is the lead sponsor of 23 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children younger than 18 years old with a diagnosis of pediatric ARDS,
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PARDS patients under noninvasive respiratory support
Device: Noninvasive respiratory support
Transition from controlled to assisted MV
Device: Transition from controlled to assisted mechanical ventilation
Weaning from MV
Device: Weaning from mechanical ventilation
sEMG of respiratory muscles, esophageal manometry, and electrical impedance tomography
sEMG of respiratory muscles, esophageal monitoring, and electrical impedance tomography
sEMG of respiratory muscles, esophageal monitoring, and electrical impedance tomography
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.
Time frame: From enrollment to the end of respiratory support, with a maximal follow-up of 30 days.
Early changes in regional lung aeration, perfusion, or ventilation/perfusion mismatch
Assesed by electrical impedance tomography
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.
The correlation between surrogates and gold-standard assessments of respiratory drive and effort
Time frame: From enrollment to the end of respiratory support, with a maximal follow-up of 30 days.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: From January 1st, 2027 to December 31st, 2031
Access criteria: By request to the principal investigator, other research groups whose main research lines are PARDS/ respiratory effort/ mechanical ventilation.
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