Role of Dyspnea in the Progression of Pediatric Acute Respiratory Distress Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorUniversidad Nacional Andres Bello

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

Children younger than 18 years old with a diagnosis of pediatric ARDS,

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Noninvasive respiratory support

    Device

    sEMG of respiratory muscles, esophageal manometry, and electrical impedance tomography

  • Transition from controlled to assisted mechanical ventilation

    Device

    sEMG of respiratory muscles, esophageal monitoring, and electrical impedance tomography

  • Weaning from mechanical ventilation

    Device

    sEMG of respiratory muscles, esophageal monitoring, and electrical impedance tomography

Treatment groups

68 Participants
are divided into 3 treatment groups
Group A: PARDS/acute phase1 intervention
Group B: PARDS/intermediate phase1 intervention
Group C: PARDS/ late phase1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

Ventilator-free days

Time frame
From enrollment to the end of respiratory support, with a maximal follow-up of 30 days.

Other outcomes

1

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.

Sponsors and contacts

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Universidad Nacional Andres Bello

Lead sponsor

Pontificia Universidad Catolica de Chile

Collaborator

Universidad de los Andes, Chile

Collaborator