Clinical trial NCT05731024: Closed-loop Synchronization Versus Conventional Synchronization
Official title: Protocol for Comparing Closed-loop syncHronization vErsuS convenTional Synchronization In sPontaneously Breathing Pediatric Patients (CHESTSIPP) - a Randomized Cross-over Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Failure
Pediatric Respiratory Distress Syndrome
Keywords: Acute respiratory failure (ARF)
Pediatric acute respiratory distress syndrome (PARDS)
Closed-loop
synchronization
patient ventilator asynchrony
Lead sponsor: Dr. Behcet Uz Children's Hospital
Sponsor class: OTHER
Collaborators: name: Hamilton Medical AG
First posted: 2023-02-16
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Asynchrony Index
timeFrame: 1 hour
Secondary outcomes:
measure: Major asynchronies
timeFrame: 1 hour
measure: Minor asynchronies
timeFrame: 1 hour
measure: Comfort Behavioral Score
timeFrame: 1 hour
measure: Leak
timeFrame: 1 hour
measure: Mean SpO2
timeFrame: 1 hour
measure: Mean EtCO2
timeFrame: 1 hour
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydin Obstetric and pediatrics Hospital
city: Erzurum
country: Turkey
facility: Erzurum Regional Research and Training Hospital
city: Erzurum
country: Turkey
facility: Erzurum Regional Research and Training Hospital
city: Istanbul
country: Turkey
facility: Cam Sakura Research and Training Hospital
city: Izmir
country: Turkey
facility: The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
Study officials:
affiliation: Behcet Uz Children's Hospital
name: Hasan Agin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Dijk J, Blokpoel RGT, Abu-Sultaneh S, Newth CJL, Khemani RG, Kneyber MCJ. Clinical Challenges in Pediatric Ventilation Liberation: A Meta-Narrative Review. Pediatr Crit Care Med. 2022 Dec 1;23(12):999-1008. doi: 10.1097/PCC.0000000000003025. Epub 2022 Jul 14.
citation: Emeriaud G, Newth CJ; Pediatric Acute Lung Injury Consensus Conference Group. Monitoring of children with pediatric acute respiratory distress syndrome: proceedings from the Pediatric Acute Lung Injury Consensus Conference. Pediatr Crit Care Med. 2015 Jun;16(5 Suppl 1):S86-101. doi: 10.1097/PCC.0000000000000436.
citation: Blokpoel RG, Burgerhof JG, Markhorst DG, Kneyber MC. Patient-Ventilator Asynchrony During Assisted Ventilation in Children. Pediatr Crit Care Med. 2016 May;17(5):e204-11. doi: 10.1097/PCC.0000000000000669.
citation: Colleti J Jr, Brunow de Carvalho W. Patient-Ventilator Asynchrony During Assisted Ventilation in Children: The Time to Rethink Our Knowledge. Pediatr Crit Care Med. 2016 Aug;17(8):811. doi: 10.1097/PCC.0000000000000793. No abstract available.
citation: Vignaux L, Grazioli S, Piquilloud L, Bochaton N, Karam O, Jaecklin T, Levy-Jamet Y, Tourneux P, Jolliet P, Rimensberger PC. Optimizing patient-ventilator synchrony during invasive ventilator assist in children and infants remains a difficult task*. Pediatr Crit Care Med. 2013 Sep;14(7):e316-25. doi: 10.1097/PCC.0b013e31828a8606.
citation: Blokpoel RGT, Burgerhof JGM, Markhorst DG, Kneyber MCJ. Trends in Pediatric Patient-Ventilator Asynchrony During Invasive Mechanical Ventilation. Pediatr Crit Care Med. 2021 Nov 1;22(11):993-997. doi: 10.1097/PCC.0000000000002788.