Continuous Monitoring of Lung Ventilation
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|ClinicalTrials.gov Identifier: NCT00810186|
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : March 22, 2016
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.
|Condition or disease|
|Respiratory Distress Syndrome, Newborn Pulmonary Ventilation; Newborn, Abnormal Apnea Respiration Disorders|
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.
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.
- 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.
The system is safe for the use in human subjects. The whole system is approved for safety according to the acquired standard ICE-60601
|Study Type :||Observational|
|Actual Enrollment :||77 participants|
|Observational Model:||Case Control|
|Official Title:||Continuous Monitoring of Lungs Ventilation Dynamics by Small Surface Patches That Include Safe Mechanical Sensors. A Multicenter Study.|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Newborns needing respiratory monitoring
Premature and term newborn infants (male/female)
- A data-bank of the recordings obtained at various clinical settings acquired by the sensors [ Time Frame: one year ]
- Establishment of a novel data bank that includes clinical cases of changes in ventilation and the comparison between the different monitored parameters. [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810186
|Bnai Zion Medical Center|
|Department of Neonatology, Carmel Medical Center|
|Rambam Health Care Campus|
|Study Director:||Dan Waisman, MD||Department of Neonatology Carmel Medical Center|