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Not Yet Recruiting NCT05731024

Closed-loop Synchronization Versus Conventional Synchronization

Conditions: Acute Respiratory Failure, Pediatric Respiratory Distress Syndrome

Sex: All
Ages: 1 Month – 18 Years
Phase: NA
Enrollment: 15
Sponsor: Dr. Behcet Uz Children's Hospital

Location: Turkey

Summary

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

Inclusion Criteria:Pediatric patients older than 1 month and younger than18 years of ageHospitalized at the PICU with the intention of treatment with mechanical ventilation at least for the upcoming 3 hours with spontaneous breathing activityWritten 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 participationExclusion Criteria:Formalized ethical decision to withhold or withdraw life supportPatient included in another interventional research study under consentPatient already enrolled in the present study in a previous episode of respiratory failurePregnant womanPatients deemed at high risk for the need of transportation from PICU to another ward, diagnostic unit or any other hospitalHemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine > 1 mg/hNot being able to obtain reference waveform

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05731024). StuddyBuddy aggregates publicly available trial information.