Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation

This study has been completed.
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by:
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT00702169
First received: June 19, 2008
Last updated: March 29, 2009
Last verified: March 2009

June 19, 2008
March 29, 2009
December 2007
March 2009   (final data collection date for primary outcome measure)
A data-bank of measured changes in lung dynamics at various clinical settings acquired by the chest sensors. [ Time Frame: unknown ] [ Designated as safety issue: No ]
Feasibility study to create a data-bank for assessing the changes in lung dynamics at various clinical settings by the chest motion sensors. [ Time Frame: unknown ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00702169 on ClinicalTrials.gov Archive Site
Detection of changes in lung ventilation by the novel system. Feasibility study. Comparison of the detection made by the novel system to the conventional monitoring methods in use. [ Time Frame: unknown ] [ Designated as safety issue: No ]
Detection of changes in lung ventilation. [ Time Frame: unknown ] [ Designated as safety issue: No ]
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Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation
Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation by Small Surface Patches That Include Safe Motion Sensors

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
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

Babies receiving respiratory support, born at 26 weeks and over & birth weight 700 grams.

Mechanical Ventilation
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1
Premature and term newborn infants (male/female)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Babies receiving respiratory support

Exclusion Criteria:

  • Parental refusal to be included in the study
  • Premature babies under 700 grams birth weight
  • Prematurity below 26 weeks gestation
  • Severe edematous babies (Hydrops fetalis)
  • Severe Hypoxic Ischemic Encephalopathy, initial brain injury or severe intracranial bleeding or major congenital anomalies
  • Skin reactions to the adhesive patches
Both
up to 3 Months
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00702169
Neo- 01/2006
Yes
Carmel Medical Center
Carmel Medical Center
Technion, Israel Institute of Technology
Principal Investigator: Dan Waisman, MD Department of Neonatology Carmel Medical Center
Carmel Medical Center
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP