Clinical Challenges in Pediatric Ventilation Liberation: A Meta-Narrative Review.
Jefta van Dijk, Robert G T Blokpoel, Samer Abu-Sultaneh...
https://pubmed.ncbi.nlm.nih.gov/35830707Actively Recruiting
Phase Not Applicable
Age: 1Month - 18Years
All Genders
ID05731024
Protocol for Comparing Closed-loop Synchronization Versus Conventional Synchronization in Spontaneously Breathing Pediatric Patients - a Randomized Cross-over Study
Led by Dr. Behcet Uz Children's Hospital · Updated on 2025-03-19
15
Participants Needed
5
Research Sites
4 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
Researchers are studying children aged 1 month to 18 years who are receiving mechanical ventilation due to acute respiratory failure or pediatric respiratory distress syndrome. The study aims to compare the safety and effectiveness of a closed-loop synchronization controller with conventional manual synchronization during invasive mechanical ventilation of spontaneous breathing pediatric patients in a pediatric intensive care unit (PICU). The trial involves two treatment periods, each lasting one hour. In one period, the pressure support of the child's spontaneous breathing will be automatically adjusted by the closed-loop synchronization controller using analysis of pressure and flow waveforms. In the other period, the pressure support will be manually set using conventional synchronization settings. This is a randomized crossover study where participants receive both interventions. During the study, researchers will monitor and measure the asynchrony index, major and minor asynchronies, comfort behavioral score, air leak, oxygen saturation (SpO2), and end-tidal carbon dioxide (EtCO2) during each one-hour treatment period. The trial involves close observation and evaluation of how well the synchronization methods support the child's breathing while minimizing asynchrony and discomfort.
CONDITIONS
Brief Title
Closed-loop Synchronization Versus Conventional Synchronization
Who Can Participate
Age: 1Month - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Pediatric patients older than 1 month and younger than 18 years of age
- Hospitalized at the pediatric intensive care unit (PICU) with planned mechanical ventilation for at least the next 3 hours and spontaneous breathing activity
- Written informed consent signed and dated by the patient or a relative if the patient cannot consent, after full explanation of the study
You will not qualify if you...
- Ethical decision made to withhold or withdraw life support
- Patient currently enrolled in another interventional research study
- Patient previously enrolled in this study during an earlier respiratory failure episode
- Pregnant female patients
- Patients at high risk for transport from PICU to other wards or hospitals
- Hemodynamic instability requiring continuous epinephrine or norepinephrine infusion greater than 1 mg per hour
- Inability to obtain reference waveform data from the patient
AI-Screening
AI-Powered Screening
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Approximately 2 hours total
Participants experience two different settings for synchronization of pressure support during spontaneous breathing in a randomized order.
2 consecutive 1-hour periods
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
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Research Team
H
Hasan Agin, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Monitoring of children with pediatric acute respiratory distress syndrome: proceedings from the Pediatric Acute Lung Injury Consensus Conference.
Guillaume Emeriaud, Christopher J L Newth, Pediatric Acute Lung Injury Consensus Conference Group
https://pubmed.ncbi.nlm.nih.gov/26035368Patient-Ventilator Asynchrony During Assisted Ventilation in Children.
Robert G T Blokpoel, Johannes G M Burgerhof, Dick G Markhorst...
https://pubmed.ncbi.nlm.nih.gov/26914624Patient-Ventilator Asynchrony During Assisted Ventilation in Children: The Time to Rethink Our Knowledge.
José Colleti, Werther Brunow de Carvalho
https://pubmed.ncbi.nlm.nih.gov/27500623Optimizing patient-ventilator synchrony during invasive ventilator assist in children and infants remains a difficult task*.
Laurence Vignaux, Serge Grazioli, Lise Piquilloud...
https://pubmed.ncbi.nlm.nih.gov/23842584Trends in Pediatric Patient-Ventilator Asynchrony During Invasive Mechanical Ventilation.
Robert G T Blokpoel, Johannes G M Burgerhof, Dick G Markhorst...
https://pubmed.ncbi.nlm.nih.gov/34054119Closed-loop synchronization versus conventional synchronization in spontaneously breathing pediatric patients (CHESTSIPP) - a randomized controlled cross-over study.
Gokhan Ceylan, Ozlem Sarac, Gulhan Atakul...
https://pubmed.ncbi.nlm.nih.gov/41958566