Comparing closed-loop and conventional methods for ventilator synchronization in children
Protocol for Comparing Closed-loop syncHronization vErsuS convenTional Synchronization In sPontaneously Breathing Pediatric Patients (CHESTSIPP) - a Randomized Cross-over Study
NA · Dr. Behcet Uz Children's Hospital · NCT05731024
This study is testing a new way to help ventilators work better with children who need breathing support in the hospital to see if it helps them breathe more comfortably.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Dr. Behcet Uz Children's Hospital (other) |
| Locations | 5 sites (Aydin and 4 other locations) |
| Trial ID | NCT05731024 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and efficacy of a closed-loop synchronization controller compared to conventional synchronization methods during invasive mechanical ventilation in pediatric patients. It focuses on children aged 1 month to 18 years who are hospitalized in the Pediatric Intensive Care Unit (PICU) and require mechanical ventilation for at least three hours. The study will assess the occurrence of patient-ventilator asynchrony, which can lead to complications in respiratory management. Participants will be monitored for their response to both synchronization methods to determine which is more effective in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 1 month to 18 years who are hospitalized in the PICU and require mechanical ventilation.
Not a fit: Patients who are pregnant, have a formalized decision to withdraw life support, or are deemed hemodynamically unstable may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved ventilation strategies that enhance respiratory support for critically ill children.
How similar studies have performed: While there is limited information on the success of similar closed-loop synchronization approaches, the study addresses a significant gap in managing patient-ventilator asynchrony, suggesting a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aydin and 4 other locations
- Aydin Obstetric and pediatrics Hospital — Aydin, Turkey (Türkiye) (RECRUITING)
- Erzurum Regional Research and Training Hospital — Erzurum, Turkey (Türkiye) (RECRUITING)
- Erzurum Regional Research and Training Hospital — Erzurum, Turkey (Türkiye) (RECRUITING)
- Cam Sakura Research and Training Hospital — Istanbul, Turkey (Türkiye) (RECRUITING)
- The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital — Izmir, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Hasan Agin, Professor — Behcet Uz Children's Hospital
- Study coordinator: Hasan Agin, Professor
- Email: hasanagin@gmail.com
- Phone: +905362013162
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Respiratory Failure, Pediatric Respiratory Distress Syndrome, Acute respiratory failure, Pediatric acute respiratory distress syndrome, Closed-loop, synchronization, patient ventilator asynchrony