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

NCT07750288 | Recruiting DMC

• 2 other identifiers: Fondecyt1260263Fondecyt 1260263
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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 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 we 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. We 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 tools used are gold standards for each parameter and allow real-time, bedside measurements without adding invasiveness to usual care. To test our hypothesis, we 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. We 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, we envision the future development of algorithms to help guide safer transitions between spontaneous and controlled ventilation, to improve outcomes, and prevent residual morbidity. Our interdisciplinary team of clinicians and biomedical engineers will work to customize respiratory care in critically ill children, optimizing ventilatory assistance across disease stages.

Conditions

Pediatric Acute Respiratory Distress Syndrome (PARDS)

Keywords

respiratory effort; monitoring; surface electromyography; esophageal manometry

Outcome Measures

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.

  From enrollment to the end of respiratory support at 30 days

Secondary Outcomes (2)

• Early changes in regional lung aeration, perfusion, or V/Q mismatch

  From enrollment to the end of treatment at 30 days

• Ventilator-free days

  From enrollment to the end of treatment at 30 days

Other Outcomes (1)

• The correlation between surrogates and gold-standard assessments of respiratory drive and effort

  From enrollment to the end of treatment at 30 days

Study Arms (3)

PARDS/acute

PARDS patients under noninvasive respiratory support

Device: Noninvasive respiratory support

PARDS/intermediate phase

Transition from controlled to assisted MV

Device: Transition from controlled to assisted mechanical ventilation

PARDS/ late phase

Weaning from MV

Device: Weaning from mechanical ventilation

Interventions

Noninvasive respiratory support DEVICE

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

PARDS/acute

Transition from controlled to assisted mechanical ventilation DEVICE

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

PARDS/intermediate phase

Weaning from mechanical ventilation DEVICE

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

PARDS/ late phase

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \) children younger than 18 years old; 2) diagnosis of pediatric ARDS, as defined by the 2023 Pediatric Acute Lung Injury Consensus Conference (PALICC2); and 3) consent to participate given by legal guardians.

You may not qualify if:

• \) tracheostomy; 2) neuromuscular disease; 3) uncorrected congenital heart diseases; 4) contraindication of esophageal catheter (choanal atresia, esophageal issues, recent esophageal surgery, etc.) or EIT (pacemakers, defibrillators, and unstable fractures). We will consider any emergency intubation as a criterion of early termination.

Sponsors & Collaborators

• Universidad Nacional Andres Bello: lead
• Pontificia Universidad Catolica de Chile: collaborator
• Universidad de los Andes, Chile: collaborator

Study Sites (1)

Hospital El Carmen Dr. Luis Valentin Ferrada

Santiago, Chile

RECRUITING

Central Study Contacts

Pablo Cruces, Full Professor

CONTACT

(56)990200810; pablo.cruces@unab.cl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; Pediatric Critical Care

Study Record Dates

• First Submitted: August 1, 2026
• First Posted: August 6, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): March 31, 2030
• Last Updated: August 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: From January 1st, 2027 to December 31st, 2031
• Access Criteria: After request to the principal investigator, other research groups whose main research lines are PARDS/ respiratory effort/ mechanical ventilation

Locations

CL (1)