Closed-loop Synchronization Versus Conventional Synchronization

NCT05731024 | Recruiting

• 1 other identifier: 02019336
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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).

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

Outcome Measures

Primary Outcomes (1)

• Asynchrony Index

  \[(major asynchronies+minor asynchronies )/(total number of breaths + ineffective efforts)\]x100

  1 hour

Secondary Outcomes (6)

• Major asynchronies

  1 hour

• Minor asynchronies

  1 hour

• Comfort Behavioral Score

  1 hour

• Leak

  1 hour

• Mean SpO2

  1 hour

Study Arms (2)

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.

Device: close-loop synchronization controller with SPONT mode

Conventional

ACTIVE COMPARATOR

One-hour period where the synchronization of pressure support of patient effort during SPONT mode will be manually set.

Device: Conventional synchronization settings with SPONT mode

Interventions

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.

Close-loop synchronization controller

Conventional synchronization settings with SPONT mode DEVICE

One-hour period where the pressure support of spontaneous breath will be manually set.

Conventional

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead
• Hamilton Medical AG: collaborator

Study Sites (5)

Aydin Obstetric and pediatrics Hospital

Aydin, 09020, Turkey (Türkiye)

RECRUITING

Erzurum Regional Research and Training Hospital

Erzurum, 25180, Turkey (Türkiye)

RECRUITING

Erzurum Regional Research and Training Hospital

Erzurum, 25180, Turkey (Türkiye)

RECRUITING

Cam Sakura Research and Training Hospital

Istanbul, 34001, Turkey (Türkiye)

RECRUITING

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Izmir, 35200, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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 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.

  PMID: 26035368 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.

  PMID: 26914624 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.

  PMID: 27500623 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.

  PMID: 23842584 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.

  PMID: 34054119 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Patient-Ventilator Asynchrony

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hasan Agin, Professor

  Behcet Uz Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan Agin, Professor

CONTACT

+905362013162; hasanagin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 16, 2023
• Study Start: February 6, 2023
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

TU (5)