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NCT Number: NCT07796321

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

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

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Key information

Conditions

Mechanical Ventilation Paediatric Dysfunctional Breathing Paediatric Intensive Care

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children (SickKids)

Toronto, Ontario, M5G 1E8, Canada

Location contact

Katherine Reise, RT

CONTACT

[email protected]

416-813-6486

About this study

Single centre, randomized crossover physiological study to assess effort of breathing and dyssynchrony burden associated with different modes of assisted ventilation in children. We hypothesize that patients on optimized pressure support ventilation (PSV) will 1) not have higher effort of breathing and 2) have a reduced rate of dyssynchronous effort compared to pressure control ventilation (PCV) or synchronized intermittent mandatory ventilation pressure control/pressure support (SIMV PC/PS) that is the current standard of care.

An esophageal catheter will be inserted and calibrated for measuring esophageal pressure (Pes) swings to quantify breathing effort and diagnose dyssynchronies. During passive breathing, the chest wall compliance will be measured. When the patients are in the ventilation weaning phase and triggering consistently in SIMV mode, a 30 min recording of respiratory signals will be performed (clinical mode) followed by exposure to two modes of assisted ventilation (PCV or PSV) in a randomized crossover manner for 30 min each. Level of support (the pressure above the PEEP) and sedation will remain stable within each participant. PSV optimization: If the PS breath is too short (< 0.2 sec), the inspiratory rise time will be increased to 0.15 sec and the cycling % reduced to 20, 15 or 10% to ensure an adequate size breath (approx 1/3 of the patient's respiratory cycle).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Consent provided
  • Aged: birth to 18 years of age
  • Invasively mechanically ventilated and expected to remain intubated for ≥ 6 hours, in the ventilator weaning phase.

Exclusion criteria

  • Contraindication for esophageal catheter placement such as esophageal repair (e.g. esophageal surgery or esophageal varices)
  • On Extracorporeal Membrane Oxygenation (ECMO)
  • Undergoing assessment for brain death or brain death confirmed
  • 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

Treatment and study plan

Pressure Control Mode

Device

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

Device

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.

Primary outcomes

  1. Average effort of breathing

    Time frame: 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.

Secondary outcomes

  1. Dyssynchrony rate quantified by specific software (FluxReview)

    Time frame: Approximately 90 minutes (30 minutes per mode of mechanical ventilation)

    Comfort quantified by RASS sedation and comfort scale. Dyssynchrony events will be summarized as the proportion of breath with any dyssynchrony per patient and period. To account for baseline variability, comparisons between PCV and PSV will be adjusted for each patient's SIMV baseline dyssynchrony. Similar to Pmus analyses, median, interquartile ranges and p-values from a Wilcoxon signed-rank test will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Cynthia de Medeiros, M.Sc.

CONTACT

[email protected]

416-813-7654 ext. 309256

Luciana Rodriguez Guerineau, M.D.

CONTACT

[email protected]

416-813-6486

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Acronym: WOB

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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