Closed-loop Synchronization Versus Conventional Synchronization (CHESTSIPP)

Dr. Behcet Uz Children's Hospital

Status: Enrolling

Conditions: Pediatric Respiratory Distress Syndrome; Acute Respiratory Failure

Treatments: Device: Conventional synchronization settings with SPONT mode; Device: close-loop synchronization controller with SPONT mode

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05731024

02019336

Details and patient eligibility

About

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).

Enrollment: 15 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Close-loop synchronization controller

Experimental group

Description:

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.

Treatment:

Device: close-loop synchronization controller with SPONT mode

Conventional

Active Comparator group

Description:

One-hour period where the synchronization of pressure support of patient effort during SPONT mode will be manually set.

Treatment:

Device: Conventional synchronization settings with SPONT mode