Protocol for Comparing Closed-loop syncHronization vErsuS convenTional Synchronization In sPontaneously Breathing Pediatric Patients (CHESTSIPP) - a Randomized Cross-over Study
| Registry | NCT05731024, acronym CHESTSIPP |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: single, treatment |
| Enrollment | 15 (Estimated) |
| Sponsor | Dr. Behcet Uz Children's Hospital (Other); collaborators: Hamilton Medical AG |
| Conditions | Acute Respiratory Failure, Pediatric Respiratory Distress Syndrome |
| Interventions | close-loop synchronization controller with SPONT mode, Conventional synchronization settings with SPONT mode (Device) |
| Dates | start 2023-02-06, primary completion 2025-11-30 (estimated), completion 2025-12-30 (estimated), first posted 2023-02-16, last updated 2025-03-19 |
| Locations | 5 sites in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Acute Respiratory Failure All trials for Pediatric Respiratory Distress Syndrome All trials of close-loop synchronization controller with SPONT mode All trials of Conventional synchronization settings with SPONT mode
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Close-loop synchronization controller | Experimental | Device: close-loop synchronization controller with SPONT mode | 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. |
| Conventional | Active comparator | Device: Conventional synchronization settings with SPONT mode | One-hour period where the synchronization of pressure support of patient effort during SPONT mode will be manually set. |
Sex: All, ages: 1 Month to 18 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Aydin Obstetric and pediatrics Hospital | Aydin | Turkey (Türkiye) | Recruiting |
| Erzurum Regional Research and Training Hospital | Erzurum | Turkey (Türkiye) | Recruiting |
| Erzurum Regional Research and Training Hospital | Erzurum | Turkey (Türkiye) | Recruiting |
| Cam Sakura Research and Training Hospital | Istanbul | Turkey (Türkiye) | Recruiting |
| The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital | Izmir | Turkey (Türkiye) | Recruiting |