Closed-loop Synchronization Versus Conventional Synchronization

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorDr. Behcet Uz Children's Hospital

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

15 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dr. Behcet Uz Children's Hospital

Lead sponsor

Hamilton Medical AG

Collaborator