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Sponsors and Collaborators: |
Pneumedicare Ltd. Carmel Medical Center Bnai Zion Medical Center Rambam Health Care Campus |
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Information provided by: | Pneumedicare Ltd. |
ClinicalTrials.gov Identifier: | NCT00810186 |
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 mechanics, 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 |
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Respiratory Distress Mechanical Ventilation Apnea Respiratory Support |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | Continuous Monitoring of Lungs Ventilation Dynamics by Small Surface Patches That Include Safe Mechanical Sensors. A Multicenter Study. |
Estimated Enrollment: | 200 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Premature and term newborn infants (male/female)
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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
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
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Infants that require tight monitoring of lung ventilation admited to the Neonatal Intensive Care Unit.
Inclusion Criteria:
Exclusion Criteria:
Contact: Dan Waisman, MD | +972-545221303 | dwaisman@netvision.net.il |
Contact: Carmit Levy, PhD | +972543057332 | carmit@pneumedicare.com |
Israel | |
Department of Neonatology, Carmel Medical Center | |
Haifa, Israel | |
Rambam Health Care Campus | |
Haifa, Israel | |
Bnai Zion Medical Center | |
Haifa, Israel |
Study Director: | Dan Waisman, MD | Department of Neonatology Carmel Medical Center |
Responsible Party: | Carmel Medical Center ( Pneumedicare (company) ) |
Study ID Numbers: | NEO-01/2008 |
Study First Received: | December 15, 2008 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00810186 |
Health Authority: | Israel: Ministry of Health |
Apnea |