CHESTSIPP: Closed-loop Synchronization Versus Conventional Synchronization

Sponsor

Dr. Behcet Uz Children's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05731024

Collaborator

Hamilton Medical AG (Industry)

Enrollment

Locations

Arms

7.8

Anticipated Duration (Months)

3.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Failure Pediatric Respiratory Distress Syndrome	Device: close-loop synchronization controller with SPONT mode Device: Conventional synchronization settings with SPONT mode	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 6, 2023

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Major asynchronies [1 hour]
[(major asynchronies)/(total number of breaths + ineffective efforts)]x100
Minor asynchronies [1 hour]
[(minor asynchronies)/(total number of breaths + ineffective efforts)]x100
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 (%)
Mean EtCO2 [1 hour]
Mean end-tidal carbon dioxide (mm Hg)

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Aydin Obstetric and pediatrics Hospital	Aydın	Turkey	09020
2	Erzurum Regional Research and Training Hospital	Erzurum	Turkey	25180
3	Cam Sakura Research and Training Hospital	Istanbul	Turkey	34001
4	The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital	Izmir	Turkey	35200