NCT05731024 Closed-loop Synchronization Versus Conventional Synchronization
| NCT ID | NCT05731024 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. Behcet Uz Children's Hospital |
| Condition | Acute Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-02-06 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2023-02-06 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Hasan Agin, Professor
PRINCIPAL INVESTIGATOR
Behcet Uz Children's Hospital
Frequently Asked Questions
Who can join the NCT05731024 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 18 Years, studying Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05731024 currently recruiting?
Yes, NCT05731024 is actively recruiting participants. Contact the research team at hasanagin@gmail.com for enrollment information.
Where is the NCT05731024 trial being conducted?
This trial is being conducted at Aydin, Turkey (Türkiye), Erzurum, Turkey (Türkiye), Erzurum, Turkey (Türkiye), Istanbul, Turkey (Türkiye) and 1 additional location.
Who is sponsoring the NCT05731024 clinical trial?
NCT05731024 is sponsored by Dr. Behcet Uz Children's Hospital. The principal investigator is Hasan Agin, Professor at Behcet Uz Children's Hospital. The trial plans to enroll 15 participants.