An Observational Cohort Study of Distribution of Ventilation in Infants and Children Requiring Mechanical Ventilation by Electrical Impedance Tomography
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Children's Hospital
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Distribution of Ventilation
Study Overview
Brief Summary
Respiratory disorders are the leading cause of respiratory failure in children. Thousands of children are admitted to a pediatric intensive care unit each year and placed on mechanical ventilators. Despite over 40 years since the first pediatric-specific ventilator was designed, there has been no specific cardiopulmonary directed therapy that has proven superior. While mechanical ventilation is generally lifesaving, it can be associated with adverse events. There is evidence building to suggest that adopting a lung protective ventilation strategy by the avoidance of lung over-distension and collapse reduces death. Therefore, timely discovery of these two lung conditions is extremely important in order to mitigate the effects associated with positive pressure mechanical ventilation. The investigators research team has extensive research experience with a non-invasive and radiation free medical device called electrical impendence tomography (EIT). EIT is intended to generate regional information of changes in ventilation. Meaning it can detect this collapse and overdistension. This additional source of information could help fine tune the mechanical ventilator. A baseline of understanding of how often this occurs in the patients the investigators serve is required. Therefore the investigators propose an EIT observation study in their pediatric ICU patient population.
Detailed Description
A. Specific Aims/Objectives Specific Aim 1: To determine regional compliance and distribution of ventilation in a cohort of children requiring mechanical ventilation. Hypothesis - Abnormal distribution of ventilation will be discovered in all patients.
Specific Aim 2: To determine changes in regional distribution of ventilation over the course of mechanical ventilation therapy. Hypothesis - Distribution of regional ventilation will change significantly as the patient's lung function improves and as they progress towards liberation from mechanical ventilation.
Specific Aim 3: To compare previously developed EIT guided ventilation algorithms by BCH research team with medical team decisions regarding mechanical ventilation. Hypothesis - EIT guided ventilation algorithms will identify changes to minimize atelectasis and overdistension sooner than clinical team decisions.
B. Background and Significance Clinical decisions regarding the mechanical ventilator rely heavily on clinical judgment typically based on intermittent and subjective assessments of relevant physiologic parameters which only reflect global lung function and without consideration for regional distribution of ventilation. Until recently there has not been a way to determine regional distribution of ventilation without exposing a patient to radiation in the form of a chest radiograph (CXR) or computer aided tomography (CT). CT and CXR provide regionally specific information but only as a snapshot in time. Determining how different regions of the lung respond to therapeutic interventions over time is challenging. However, our research team has extensive research experience with a non-invasive and radiation free medical imaging technology called electrical impendence tomography (EIT). EIT provides regional information of changes in ventilation. This additional source of information could help optimize mechanical ventilation by providing bedside clinicians with continuous decision support as the EIT data may be utilized to alert when regional collapse or over-distension is detected. However, there is little data describing changes in distribution of ventilation over time or as the patient's condition changes.
Electrical Impedance Tomography (EIT) Barber and Brown introduced electrical impedance tomography to the medical community in the early 1980s. From there a wide spectrum of applications in medicine ranging from gastric emptying, brain function, breast imaging, to lung function have been explored. It is our belief that the most valuable benefit of EIT is in the monitoring of regional lung function in critically ill patients. Early EIT devices fell susceptible to poor sensitivity and signal interference in the clinical setting. After years and a renewed interest from a few commercial companies interested in ventilation technology, many of these shortcomings have been resolved. As with any new modality, EIT and its clinical utility and application need to be methodically explored; therefore we propose this IRB protocol to take us a step closer on this journey to develop a clinically useful tool9.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Day to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients who require mechanical ventilatory assistance. This includes invasive and noninvasive ventilation.
- •Ages 1 day (full term defined as > 37 wks GA) to 17 years of age.
Exclusion Criteria
- •Patients with unstable spinal injuries or diseases
- •Body mass index > 50
- •Active implant such as pacemaker, ICD, or diaphragm pacer
- •Patient who is having cardiac arrhythmias
- •Skin integrity issues in the area that the belt / electrodes will be placed, such as ulcers or open wounds
- •Dressings or chest tubes that prohibit the placement of electrodes in the proper plain.
- •Open chest
- •Flail chest within the regional plain of the belt / electrodes
- •If the medical team feels that the patient is not appropriate to enroll in the study based on medical, social or emotional concerns
- •If the patient is too unstable to position the belt / electrodes and/or transition to the Draeger ventilator
- •Patient has been supported on mechanical ventilation for longer than 48 hours prior to enrollment
- •Post-operative spinal fusion patients
Outcomes
Primary Outcomes
Distribution of Ventilation
Time Frame: Every 24 hours or after PEEP changes
Distribution of ventilation as determined by changes in impedence in layers or quarters.
Secondary Outcomes
- Distribution of Ventilation Changes Over Time(Every 24 hours for the duration of mechanical ventilation)
Investigators
Brian Walsh
Research Coordinator
Boston Children's Hospital