Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation
Condition: Mechanical Ventilation
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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
Sampling method: Probability Sample
Study population: 
        Babies receiving respiratory support, born at 26 weeks and over & birth weight 700 grams.
      
Keywords: high frequency ventilation monitoring; lung disease; Respiratory distress syndrome; lung barotrauma; mechanical ventilation; endotracheal tube displacement; endotracheal tube occlusion; one lung intubation