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Closed-loop Synchronization Versus Conventional Synchronization

ConditionsAcute Respiratory FailurePediatric Respiratory Distress Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorDr. Behcet Uz Children's Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • Conventional synchronization settings with SPONT mode

    Device

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

Treatment groups

15 Participants
are divided into 2 treatment groups
Group A: Close-loop synchronization controllerExperimental treatment 1 intervention
Group B: ConventionalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Asynchrony Index

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

Time frame
1 hour

Secondary outcomes

1

Major asynchronies

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

Time frame
1 hour
2

Minor asynchronies

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

Time frame
1 hour
3

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

Time frame
1 hour
4

Leak

Percentage of leak around endotrachel tube (%)

Time frame
1 hour

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Behcet Uz Children's Hospital

Lead sponsor

Hamilton Medical AG

Collaborator

Source ClinicalTrials.gov
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