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Starting soon Not applicable

Effort of Breathing and Dyssynchrony Burden During Assisted Ventilation in Paediatric Patients

NCT07796321 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2026-09-21
Last updated
2026-09-01

Condition(s) studied

Mechanical VentilationPaediatric Intensive CarePaediatric Dysfunctional Breathing

Investigational drug(s) / intervention(s)

Pressure Control ModePressure Support Mode

Pressure Control Mode: In pressure control mode every breath is controlled by the ventilator, including when the breaths are delivered. This mode is typically used when patients are sedated and unable to breathe on their own.

Pressure Support Mode: In pressure support mode every breath is initiated and controlled by the patient. This mode is used when patients are awake enough to take all breaths on their own.

Study summary

The goal of this trial is to learn if one mode of mechanical ventilation (i.e. machine to help with breathing) is better than another in children who need help from a machine to breathe. The main questions it aims to answer are:

* How hard do children need to work to breathe when they are using different types of modes of mechanical ventilation?
* Evaluate which mode of mechanical ventilation performs better when the patient is clinically awake enough to start breaths

Eligibility

Sex
ALL
Min age
—
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. Consent provided 2. Aged: birth to 18 years of age 3. Invasively mechanically ventilated and expected to remain intubated for ≥ 6 hours, in the ventilator weaning phase. Exclusion Criteria: 1. Contraindication for esophageal catheter placement such as esophageal repair (e.g. esophageal surgery or esophageal varices) 2. On Extracorporeal Membrane Oxygenation (ECMO) 3. Undergoing assessment for brain death or brain death confirmed 4. Patients with a severe systemic disease that poses a constant threat to their life: * \<24 hrs post cardiac arrest * 2 or more inotropes increasing by \>20% within the last 24 hrs * increase in ventilation support or an FiO2 change ≥30% within the last 24 hrs * most responsible physician (MRP) determine patient is not eligible for the study intervention

Primary outcome measure(s)

  • Average effort of breathing — Analyses will be performed on patient-level summaries averaged over the last 25 minutes of each ventilation mode (SIMV, PCV, PSV).
    Muscular pressure or Pmus (calculated from DPes and using the chest wall compliance of the participant and measured by specific software \[FluxReview\]) during the assisted modes. For each patient, the change in Pmus from SIMV to PSV and from SIMV to PCV will be computed. The within-patient difference between these changes will be summarized in terms of median and interquartile range, and assessed using a Wilcoxon signed-rank test.

Trial sites (1)

FacilityCityRegionStatus
The Hospital for Sick Children (SickKids) Toronto Ontario
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07796321 on ClinicalTrials.gov ↗ ← All trials in Canada