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| Name | Class |
|---|---|
| Hamilton Medical AG | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Close-loop synchronization controller | Experimental | One-hour period where the pressure support of spontaneous effort will be automatically titrated based on pressure and flow waveform analysis obtained from the patient during SPONT mode. |
|
| Conventional | Active Comparator | One-hour period where the synchronization of pressure support of patient effort during SPONT mode will be manually set. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| close-loop synchronization controller with SPONT mode | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Asynchrony Index | [(major asynchronies+minor asynchronies )/(total number of breaths + ineffective efforts)]x100 | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Major asynchronies | [(major asynchronies)/(total number of breaths + ineffective efforts)]x100 | 1 hour |
| Minor asynchronies | [(minor asynchronies)/(total number of breaths + ineffective efforts)]x100 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hasan Agin, Professor | Contact | +905362013162 | hasanagin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hasan Agin, Professor | Behcet Uz Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aydin Obstetric and pediatrics Hospital | Recruiting | Aydin | 09020 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35830707 | Background | 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. | |
| 26035368 | Background | 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. |
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| Conventional synchronization settings with SPONT mode | Device | One-hour period where the pressure support of spontaneous breath will be manually set. |
|
| 1 hour |
| Comfort Behavioral Score | The Comfort Behavioral Scale yields points based on scores obtained from the Comfort B Scale. Scores below 10 indicate that the patient may be over-sedated, while scores between 12 and 17 suggest that the patient is adequately comfortable. Scores above 17 may suggest that the patient is experiencing inadequate sedation | 1 hour |
| Leak | Percentage of leak around endotrachel tube (%) | 1 hour |
| Mean SpO2 | Mean peripheral oxygen saturation (%) | 1 hour |
| Mean EtCO2 | Mean end-tidal carbon dioxide (mm Hg) | 1 hour |
| Erzurum Regional Research and Training Hospital | Recruiting | Erzurum | 25180 | Turkey (Türkiye) |
|
| Erzurum Regional Research and Training Hospital | Recruiting | Erzurum | 25180 | Turkey (Türkiye) |
|
| Cam Sakura Research and Training Hospital | Recruiting | Istanbul | 34001 | Turkey (Türkiye) |
|
| The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital | Recruiting | Izmir | 35200 | Turkey (Türkiye) |
|
| 26914624 | Background | 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. |
| 27500623 | Background | 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. |
| 23842584 | Background | 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. |
| 34054119 | Background | 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. |
| 41958566 | Derived | 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. |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D000097742 | Patient-Ventilator Asynchrony |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012131 | Respiratory Insufficiency |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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