Closed-loop Synchronization Versus Conventional Synchronization

Acute Respiratory Failure Clinical Trial

— CHESTSIPP  

Official title:

Protocol for Comparing Closed-loop syncHronization vErsuS convenTional Synchronization In sPontaneously Breathing Pediatric Patients (CHESTSIPP) - a Randomized Cross-over Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05731024
• Other study ID #: 02019336
• Status: Recruiting
• Phase: N/A
• Start date: February 6, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Dr. Behcet Uz Children's Hospital
• Contact: Hasan Agin, Professor
• Phone: +905362013162
• Email: hasanagin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

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.
• Conventional synchronization settings with SPONT mode
One-hour period where the pressure support of spontaneous breath will be manually set.

Locations

Country	Name	City	State
Turkey	Aydin Obstetric and pediatrics Hospital	Aydin
Turkey	Erzurum Regional Research and Training Hospital	Erzurum
Turkey	Erzurum Regional Research and Training Hospital	Erzurum
Turkey	Cam Sakura Research and Training Hospital	Istanbul
Turkey	The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Behcet Uz Children's Hospital	Hamilton Medical AG

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asynchrony Index	[(major asynchronies+minor asynchronies )/(total number of breaths + ineffective efforts)]x100	1 hour
Secondary	Major asynchronies	[(major asynchronies)/(total number of breaths + ineffective efforts)]x100	1 hour
Secondary	Minor asynchronies	[(minor asynchronies)/(total number of breaths + ineffective efforts)]x100	1 hour
Secondary	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
Secondary	Leak	Percentage of leak around endotrachel tube (%)	1 hour
Secondary	Mean SpO2	Mean peripheral oxygen saturation (%)	1 hour
Secondary	Mean EtCO2	Mean end-tidal carbon dioxide (mm Hg)	1 hour