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| Sponsors and Collaborators: |
Carmel Medical Center Technion, Israel Institute of Technology |
|---|---|
| Information provided by: | Carmel Medical Center |
| ClinicalTrials.gov Identifier: | NCT00702169 |
Purpose
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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Mechanical Ventilation |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation by Small Surface Patches That Include Safe Motion Sensors |
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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
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
Eligibility| Ages Eligible for Study: | up to 3 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Babies receiving respiratory support, born at 26 weeks and over & birth weight 700 grams.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Dan Waisman, MD | 972-5-0626-5525 | dwaisman@netvision.net.il |
| Israel | |
| Department of Neonatology, Carmel Medical Center | Recruiting |
| Haifa, Israel | |
| Contact: Dan Waisman, MD 972-5-0626-5525 dwaisman@netvision.net.il | |
| Principal Investigator: Dan Waisman, MD | |
| Sub-Investigator: Irena Kessel, MD | |
| Sub-Investigator: Avi Rothchild, MD | |
| Sub-Investigator: Carmit Levy, PhD | |
| Sub-Investigator: Amir Landesberg, MD, D.Sc. | |
| Principal Investigator: | Dan Waisman, MD | Department of Neonatology Carmel Medical Center |
More Information
| Responsible Party: | Carmel Medical Center ( Carmel Medical Center ) |
| Study ID Numbers: | Neo- 01/2006 |
| Study First Received: | June 19, 2008 |
| Last Updated: | January 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00702169 |
| Health Authority: | Israel: Ministry of Health |
|
high frequency ventilation monitoring lung disease Respiratory distress syndrome lung barotrauma |
mechanical ventilation endotracheal tube displacement endotracheal tube occlusion one lung intubation |
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Lung Diseases |
