Health TrialsbyHealthPanel

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

ConditionsMechanical VentilationPaediatric Intensive CarePaediatric Dysfunctional Breathing
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorThe Hospital for Sick Children

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

<24 hrs post cardiac arrest

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: PCV followed by PSVExperimental treatment 2 interventions
Group B: PSV followed by PCVExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Average effort of breathing

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.

Time frame
Analyses will be performed on patient-level summaries averaged over the last 25 minutes of each ventilation mode (SIMV, PCV, PSV).

Secondary outcomes

1

Dyssynchrony rate quantified by specific software (FluxReview)

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hospital for Sick Children

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: