Closed-loop Synchronization Versus Conventional Synchronization

Not Applicable

Recruiting

• Conditions: Pediatric Respiratory Distress Syndrome; Acute Respiratory Failure
• Interventions: Device: Conventional synchronization settings with SPONT mode; Device: close-loop synchronization controller with SPONT mode

• Registration Number: NCT05731024
• Lead Sponsor: Dr. Behcet Uz Children's Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-03
• Study Start: 2023-02-06
• Study First Submitted QC: 2023-02-15
• Study First Posted: 2023-02-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2025-11-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional synchronization settings with SPONT mode	One-hour period where the synchronization of pressure support of patient effort during SPONT mode will be manually set.
Close-loop synchronization controller	close-loop synchronization controller with SPONT mode	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.

Primary Outcome Measures

Name	Time	Method
Asynchrony Index	1 hour	\[(major asynchronies+minor asynchronies )/(total number of breaths + ineffective efforts)\]x100

Secondary Outcome Measures

Name	Time	Method
Minor asynchronies	1 hour	\[(minor asynchronies)/(total number of breaths + ineffective efforts)\]x100
Major asynchronies	1 hour	\[(major asynchronies)/(total number of breaths + ineffective efforts)\]x100
Mean EtCO2	1 hour	Mean end-tidal carbon dioxide (mm Hg)
Comfort Behavioral Score	1 hour	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
Leak	1 hour	Percentage of leak around endotrachel tube (%)
Mean SpO2	1 hour	Mean peripheral oxygen saturation (%)

Trial Locations

Locations (4)

Aydin Obstetric and pediatrics Hospital; 🇹🇷 Aydın, 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, Turkey