Acute Respiratory Failure, Pediatric Respiratory Distress Syndrome
Conditions
Keywords
Acute respiratory failure (ARF), Pediatric acute respiratory distress syndrome (PARDS), Closed-loop, synchronization, patient ventilator asynchrony
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).
Interventions
DEVICEclose-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.
DEVICEConventional synchronization settings with SPONT mode
One-hour period where the pressure support of spontaneous breath will be manually set.
Sponsors
Hamilton Medical AG
Dr. Behcet Uz Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asynchrony Index | 1 hour | \[(major asynchronies+minor asynchronies )/(total number of breaths + ineffective efforts)\]x100 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Major asynchronies | 1 hour | \[(major asynchronies)/(total number of breaths + ineffective efforts)\]x100 |
| Mean SpO2 | 1 hour | Mean peripheral oxygen saturation (%) |
| Mean EtCO2 | 1 hour | Mean end-tidal carbon dioxide (mm Hg) |
| Leak | 1 hour | Percentage of leak around endotrachel tube (%) |
Countries
Turkey (Türkiye)
Contacts
Primary ContactHasan Agin, Professor
Outcome results
None listed