Closed-loop Synchronization Versus Conventional Synchronization (CHESTSIPP)

March 18, 2025 updated by: Hasan ağın, Dr. Behcet Uz Children's Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Aydın, Turkey, 09020
        • Recruiting
        • Aydin Obstetric and pediatrics Hospital
        • Contact:
      • Erzurum, Turkey, 25180
        • Recruiting
        • Erzurum Regional Research and Training Hospital
        • Contact:
          • Sevgi Topal, MD
          • Phone Number: +905078645922
      • Istanbul, Turkey, 34001
        • Recruiting
        • Cam Sakura Research and Training Hospital
        • Contact:
      • Izmir, Turkey, 35200
        • Recruiting
        • The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
        • Contact:
        • Sub-Investigator:
          • Ozlem Sandal
        • Contact:
        • Sub-Investigator:
          • Gulhan Atakul

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Close-loop synchronization controller
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
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.
Active Comparator: Conventional
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
One-hour period where the pressure support of spontaneous breath will be manually set.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asynchrony Index
Time Frame: 1 hour
[(major asynchronies+minor asynchronies )/(total number of breaths + ineffective efforts)]x100
1 hour

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Behcet Uz Children's Hospital

Collaborators

Hamilton Medical AG

Investigators

  • Principal Investigator: Hasan Agin, Professor, Behcet Uz Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 3, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02019336

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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