Apnea Clinical Trial
Official title:
Continuous Monitoring of Lungs Ventilation Dynamics by Small Surface Patches That Include Safe Mechanical Sensors. A Multicenter Study.
Background: Patients that suffer from respiratory failure and need mechanical ventilation
are at risk of further deterioration due to complications induced by progression of lung
disease or the mechanical ventilation. The complications usually develop in a progressive
manner, but are currently detected relatively late, when there is already severe and life
threatening deterioration in patient oxygenation and sometimes irreversible damages.
Objective:To measure chest wall dynamics, derived from sensors placed on the chest and
abdomen.
Methods: The system comprises of patches attached to the chest wall and upper abdomen that
include mechanical sensors that measure the mechanics of lung inflation and deflation.
Patients that suffer from respiratory failure and need mechanical ventilation are at risk of
further life threatening deterioration following the development of mechanical problems
related to airway management, development of lung barotrauma or displacement of the
endotracheal tube.
Neonates especially need tight and sensitive monitoring of lung ventilation, because of the
high prevalence of lung disease and need for ventilatory support in this population.
Methods:
The system comprises of patches attached to the chest wall and to the epigastrium. The
patches include sensors that measure the mechanics of the lung inflation and deflation.
Study protocol
- Following parental informed consent, three patches will be placed on both sides of the
chest and over the epigastric area in infants that require tight respiratory
monitoring.
- The patches will be placed just beside the ECG patches.
- The placement of the patches will be performed by a physician.
- The monitoring can be preformed as long as the baby needs a tight respiratory
monitoring. The patches will be replaced according to routine replacement policy of
patches in the neonatal intensive care units, and at the regular time defined by the
attending staff, and no longer than 24 hours. At the end of the data acquisition, the
patches will be removed.
- No additional intervention is required.
- The patient will be inspected by the supervising physician involve in the research.
- It will not provide any data that may alter the treatment and will not interfere or
influence the other monitoring devices that are used to evaluate the clinical status of
the patient.
- The other parameters that are regularly monitored, that are displayed on the bedside
monitor and respirator will be recorded by the research assistant. The ventilated baby
will be identified by a study number. There will be a separate database for the
measurements and the demographic and clinical data. There will be no disclosure of the
patient's identity along with the data analysis and publication of the results or
communication to authorities or other medical practitioners.
Equipment safety:
The system is safe for the use in human subjects. The whole system is approved for safety
according to the acquired standard ICE-60601
;
Observational Model: Case Control, Time Perspective: Prospective
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