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

Overview

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).

Interventions

• Device close-loop synchronization controller with SPONT mode
  One-hour period where the pressure support of spontaneous breath will be automatically titrated based on pressure and flow waveform analysis obtained from the patient.
• Device Conventional synchronization settings with SPONT mode
  One-hour period where the pressure support of spontaneous breath will be manually set.

Primary outcome measures

• Asynchrony Index [Time frame: 1 hour]

Secondary outcome measures (6)

• Major asynchronies [Time frame: 1 hour]
• Minor asynchronies [Time frame: 1 hour]
• Comfort Behavioral Score [Time frame: 1 hour]
• Leak [Time frame: 1 hour]
• Mean SpO2 [Time frame: 1 hour]
• Mean EtCO2 [Time frame: 1 hour]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 5 centers

• Aydin Obstetric and pediatrics Hospital — Aydin
• Erzurum Regional Research and Training Hospital — Erzurum
• Erzurum Regional Research and Training Hospital — Erzurum
• Cam Sakura Research and Training Hospital — Istanbul
• The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Trai — Izmir

Publications

• 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. PMID 35830707
• 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. PMID 26035368
• 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. PMID 26914624
• 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. PMID 27500623
• 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. PMID 23842584
• 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. PMID 34054119
• Ceylan G, Sarac O, Atakul G, Soydan E, Colak M, Topal S, Hepduman P, Novotni D, Meyer J, Karaaslan U, Revely JP, Agin H. Closed-loop synchronization versus conventional synchronization in spontaneously breathing pediatric patients (CHESTSIPP) - a randomized controlled cross-over study. Front Med (Lausanne). 2026 Mar 25;13:1745939. doi: 10.3389/fmed.2026.1745939. eCollection 2026. PMID 41958566

Identifiers

NCT: NCT05731024 · 02019336

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗