Actively Recruiting
Closed-loop Synchronization Versus Conventional Synchronization
Led by Dr. Behcet Uz Children's Hospital · Updated on 2025-03-19
15
Participants Needed
5
Research Sites
151 weeks
Total Duration
On this page
Sponsors
D
Dr. Behcet Uz Children's Hospital
Lead Sponsor
H
Hamilton Medical AG
Collaborating Sponsor
AI-Summary
What this Trial Is 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).
CONDITIONS
Official Title
Closed-loop Synchronization Versus Conventional Synchronization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients older than 1 month and younger than 18 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Aydin Obstetric and pediatrics Hospital
Aydin, Turkey (Türkiye), 09020
Actively Recruiting
2
Erzurum Regional Research and Training Hospital
Erzurum, Turkey (Türkiye), 25180
Actively Recruiting
3
Erzurum Regional Research and Training Hospital
Erzurum, Turkey (Türkiye), 25180
Actively Recruiting
4
Cam Sakura Research and Training Hospital
Istanbul, Turkey (Türkiye), 34001
Actively Recruiting
5
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Izmir, Turkey (Türkiye), 35200
Actively Recruiting
Research Team
H
Hasan Agin, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here