Closed-loop Synchronization Versus Conventional Synchronization

Study Overview
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Brief Summary
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A prior research indicated that asynchrony between the patient and ventilator occurred in 33 percent of 19,175 breaths, and was seen in every patient. The most prevalent kind of asynchrony was ineffective triggering (68%), followed by delayed termination (19%), double triggering (4%) and premature termination (3%). Asynchrony between the patient and ventilator increased considerably with decreasing levels of peak inspiratory pressure, positive end-expiratory pressure, and set frequency.Despite this, more asynchrony categories exist, and there is no widely accepted categorization. Major asynchronies, however, include auto trigger, ineffective effort, and double trigger, while minor asynchronies include early/late cycle, trigger delay, and spontaneous breaths during a mandatory breath. This study aims to compare the safety and efficacy of a closed-loop synchronization controller with conventional control of synchronization during invasive mechanical ventilation of spontaneous breathing of pediatric patients in a pediatric intensive care unit (PICU).

Official Title
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Protocol for Comparing Closed-loop syncHronization vErsuS convenTional Synchronization In sPontaneously Breathing Pediatric Patients (CHESTSIPP) - a Randomized Cross-over Study

Conditions
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Acute Respiratory Failure, Pediatric Respiratory Distress Syndrome

Intervention / Treatment
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* Device: close-loop synchronization controller with SPONT mode
* Device: Conventional synchronization settings with SPONT mode


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients older than 1 month and younger than18 years of age Hospitalized at the PICU with the intention of treatment with mechanical ventilation at least for the upcoming 3 hours with spontaneous breathing activity Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation Exclusion Criteria: Formalized ethical decision to withhold or withdraw life support Patient included in another interventional research study under consent Patient already enrolled in the present study in a previous episode of respiratory failure Pregnant woman Patients deemed at high risk for the need of transportation from PICU to another ward, diagnostic unit or any other hospital Hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/h Not being able to obtain reference waveform

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Close-loop synchronization controller<br>One-hour period where the pressure support of spontaneous effort will be automatically titrated based on pressure and flow waveform analysis obtained from the patient during SPONT mode. | Device: close-loop synchronization controller with SPONT mode<br>* One-hour period where the pressure support of spontaneous breath will be automatically titrated based on pressure and flow waveform analysis obtained from the patient.<br>|
| Active Comparator: Conventional<br>One-hour period where the synchronization of pressure support of patient effort during SPONT mode will be manually set. | Device: Conventional synchronization settings with SPONT mode<br>* One-hour period where the pressure support of spontaneous breath will be manually set.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asynchrony Index | [(major asynchronies+minor asynchronies )/(total number of breaths + ineffective efforts)]x100 | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major asynchronies | [(major asynchronies)/(total number of breaths + ineffective efforts)]x100 | 1 hour | 
| Minor asynchronies | [(minor asynchronies)/(total number of breaths + ineffective efforts)]x100 | 1 hour | 
| Comfort Behavioral Score | The Comfort Behavioral Scale yields points based on scores obtained from the Comfort B Scale. Scores below 10 indicate that the patient may be over-sedated, while scores between 12 and 17 suggest that the patient is adequately comfortable. Scores above 17 may suggest that the patient is experiencing inadequate sedation | 1 hour | 
| Leak | Percentage of leak around endotrachel tube (%) | 1 hour | 
| Mean SpO2 | Mean peripheral oxygen saturation (%) | 1 hour | 
| Mean EtCO2 | Mean end-tidal carbon dioxide (mm Hg) | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS), Closed-loop, synchronization, patient ventilator asynchrony