About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- close-loop synchronization controller with SPONT mode
- Conventional synchronization settings with SPONT mode
Treatment groups
Sponsors and collaborators
Dr. Behcet Uz Children's Hospital
Lead sponsor
Hamilton Medical AG
Collaborator