search
Back to results

Closed-loop Synchronization Versus Conventional Synchronization (CHESTSIPP)

Primary Purpose

Acute Respiratory Failure, Pediatric Respiratory Distress Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
close-loop synchronization controller with SPONT mode
Conventional synchronization settings with SPONT mode
Sponsored by
Dr. Behcet Uz Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure focused on measuring Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS), Closed-loop, synchronization, patient ventilator asynchrony

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aydin Obstetric and pediatrics HospitalRecruiting
  • Erzurum Regional Research and Training HospitalRecruiting
  • Erzurum Regional Research and Training HospitalRecruiting
  • Cam Sakura Research and Training HospitalRecruiting
  • The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Close-loop synchronization controller

Conventional

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 3, 2023
Last Updated
September 14, 2023
Sponsor
Dr. Behcet Uz Children's Hospital
Collaborators
Hamilton Medical AG
search

1. Study Identification

Unique Protocol Identification Number
NCT05731024
Brief Title
Closed-loop Synchronization Versus Conventional Synchronization
Acronym
CHESTSIPP
Official Title
Protocol for Comparing Closed-loop syncHronization vErsuS convenTional Synchronization In sPontaneously Breathing Pediatric Patients (CHESTSIPP) - a Randomized Cross-over Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Behcet Uz Children's Hospital
Collaborators
Hamilton Medical AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Pediatric Respiratory Distress Syndrome
Keywords
Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS), Closed-loop, synchronization, patient ventilator asynchrony

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Close-loop synchronization controller
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
One-hour period where the synchronization of pressure support of patient effort during SPONT mode will be manually set.
Intervention Type
Device
Intervention Name(s)
close-loop synchronization controller with SPONT mode
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Conventional synchronization settings with SPONT mode
Intervention Description
One-hour period where the pressure support of spontaneous breath will be manually set.
Primary Outcome Measure Information:
Title
Asynchrony Index
Description
[(major asynchronies+minor asynchronies )/(total number of breaths + ineffective efforts)]x100
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Major asynchronies
Description
[(major asynchronies)/(total number of breaths + ineffective efforts)]x100
Time Frame
1 hour
Title
Minor asynchronies
Description
[(minor asynchronies)/(total number of breaths + ineffective efforts)]x100
Time Frame
1 hour
Title
Comfort Behavioral Score
Description
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
Time Frame
1 hour
Title
Leak
Description
Percentage of leak around endotrachel tube (%)
Time Frame
1 hour
Title
Mean SpO2
Description
Mean peripheral oxygen saturation (%)
Time Frame
1 hour
Title
Mean EtCO2
Description
Mean end-tidal carbon dioxide (mm Hg)
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hasan Agin, Professor
Phone
+905362013162
Email
hasanagin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Agin, Professor
Organizational Affiliation
Behcet Uz Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aydin Obstetric and pediatrics Hospital
City
Aydın
ZIP/Postal Code
09020
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ekin soydan
Phone
+905321003949
Email
dr-ekinsoydan@hotmail.com
Facility Name
Erzurum Regional Research and Training Hospital
City
Erzurum
ZIP/Postal Code
25180
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pinar Hepduman, MD
Phone
+905531501115
Email
pnrhpdmn@gmail.com
Facility Name
Erzurum Regional Research and Training Hospital
City
Erzurum
ZIP/Postal Code
25180
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sevgi Topal, MD
Phone
+905078645922
Facility Name
Cam Sakura Research and Training Hospital
City
Istanbul
ZIP/Postal Code
34001
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa Colak, MD
Phone
+905554180903
Email
colakk@hotmail.com
Facility Name
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
City
Izmir
ZIP/Postal Code
35200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ozlem Sandal, MD
Phone
+905067644688
Email
drozlemsarac@hotmail.com
First Name & Middle Initial & Last Name & Degree
Gulhan Atakul, MD
Email
gulhanatakul@gmail.com
First Name & Middle Initial & Last Name & Degree
Ozlem Sandal
First Name & Middle Initial & Last Name & Degree
Gulhan Atakul

12. IPD Sharing Statement

Citations:
PubMed Identifier
35830707
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.
Results Reference
background
PubMed Identifier
26035368
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.
Results Reference
background
PubMed Identifier
26914624
Citation
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.
Results Reference
background
PubMed Identifier
27500623
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.
Results Reference
background
PubMed Identifier
23842584
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.
Results Reference
background
PubMed Identifier
34054119
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.
Results Reference
background

Learn more about this trial

Closed-loop Synchronization Versus Conventional Synchronization

We'll reach out to this number within 24 hrs