Continuous Monitoring of Lung Ventilation

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Pneumedicare Ltd.
Sponsor:
Collaborators:
Carmel Medical Center
Bnai Zion Medical Center
Rambam Health Care Campus
Information provided by (Responsible Party):
Pneumedicare Ltd.
ClinicalTrials.gov Identifier:
NCT00810186
First received: December 15, 2008
Last updated: January 7, 2014
Last verified: January 2014
  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 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
Respiratory Distress Syndrome, Newborn
Pulmonary Ventilation; Newborn, Abnormal
Apnea
Respiration Disorders

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Continuous Monitoring of Lungs Ventilation Dynamics by Small Surface Patches That Include Safe Mechanical Sensors. A Multicenter Study.

Resource links provided by NLM:


Further study details as provided by Pneumedicare Ltd.:

Primary Outcome Measures:
  • A data-bank of the recordings obtained at various clinical settings acquired by the sensors [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2009
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Newborns needing respiratory monitoring
Premature and term newborn infants (male/female)

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Infants that require tight monitoring of lung ventilation admited to the Neonatal Intensive Care Unit.

Criteria

Inclusion Criteria:

  • Infants that require tight monitoring of lung ventilation.
  • Parents that understand and read Hebrew or Russian or Arabic.

Exclusion Criteria:

  • Parental refusal to participate in the study.
  • Premature babies under 700 grams.
  • Prematurity below 26 weeks gestation.
  • Severe edematous babies (Hydrops fetalis).
  • Severe Hypoxic Ischemic Encephalopathy, initial brain injury or severe intracranial bleeding.
  • Skin reactions to the adhesive patches.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810186

Contacts
Contact: Dan Waisman, MD +972-545221303 dwaisman@netvision.net.il
Contact: Carmit Levy, PhD +972543057332 carmit@pneumedicare.com

Locations
Israel
Department of Neonatology, Carmel Medical Center Recruiting
Haifa, Israel
Contact: Dan Waisman, MD    +972-545221303    dwaisman@netvision.net.il   
Sub-Investigator: Irena Kessel, MD         
Principal Investigator: Avi Rotschild, MD         
Sub-Investigator: Dan Waisman, MD         
Rambam Health Care Campus Completed
Haifa, Israel
Bnai Zion Medical Center Completed
Haifa, Israel
Sponsors and Collaborators
Pneumedicare Ltd.
Carmel Medical Center
Bnai Zion Medical Center
Rambam Health Care Campus
Investigators
Study Director: Dan Waisman, MD Department of Neonatology Carmel Medical Center
  More Information

No publications provided

Responsible Party: Pneumedicare Ltd.
ClinicalTrials.gov Identifier: NCT00810186     History of Changes
Other Study ID Numbers: NEO-01/2008
Study First Received: December 15, 2008
Last Updated: January 7, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiration Disorders
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 30, 2014