Clinical trial NCT00702169: Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation
Official title: Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation by Small Surface Patches That Include Safe Motion Sensors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Keywords: high frequency ventilation monitoring
lung disease
Respiratory distress syndrome
lung barotrauma
mechanical ventilation
endotracheal tube displacement
endotracheal tube occlusion
one lung intubation
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2008-06-20
Enrollment: 15
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Babies receiving respiratory support, born at 26 weeks and over \& birth weight 700 grams.

Brief summary: 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.

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 criteria: 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

Primary outcomes:
measure: A data-bank of measured changes in lung dynamics at various clinical settings acquired by the chest sensors.
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Neonatology, Carmel Medical Center
Study officials:
affiliation: Department of Neonatology Carmel Medical Center
name: Dan Waisman, MD
role: PRINCIPAL_INVESTIGATOR
References: