Continuous Monitoring of the Lungs Ventilation Dynamics During Mechanical Ventilation

NCT00702169 | Completed DMC

• 1 other identifier: Neo- 01/2006
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• A data-bank of measured changes in lung dynamics at various clinical settings acquired by the chest sensors.

Secondary Outcomes (1)

• 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.

Study Arms (1)

1

Premature and term newborn infants (male/female)

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Babies receiving respiratory support

You may not qualify if:

• 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

Sponsors & Collaborators

• Carmel Medical Center: lead
• Technion, Israel Institute of Technology: collaborator

Study Sites (1)

Department of Neonatology, Carmel Medical Center

Haifa, 32985, Israel

Location

MeSH Terms

Conditions

Lung Diseases; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Dan Waisman, MD

  Department of Neonatology Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Directon Newborn Unit

Study Record Dates

• First Submitted: June 19, 2008
• First Posted: June 20, 2008
• Study Start: December 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

IL (1)