Observational Cohort Study of Distribution of Ventilation in Pediatrics Requiring Mechanical Ventilation by Electrical Impedance Tomography

NCT02247700 | Completed

• 1 other identifier: IRB-P00013295
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure; Acute Respiratory Distress Syndrome; Acute Lung Injury

Keywords

Pediatrics; ARDS; ARF; ALI; Respiratory; Mechanical ventilation; Ventilation; Noninvasive monitoring; electrical impedance tomography; EIT

Outcome Measures

Primary Outcomes (1)

• Distribution of Ventilation

  Distribution of ventilation as determined by changes in impedence in layers or quarters.

  Every 24 hours or after PEEP changes

Secondary Outcomes (1)

• Distribution of Ventilation Changes Over Time

  Every 24 hours for the duration of mechanical ventilation

Other Outcomes (1)

• EIT Guided Ventilation Algorithms

  Images pre change in PEEP compared to post change

Study Arms (1)

Mechanical Ventilation

Infants and Children requiring mechanical ventilation

Eligibility Criteria

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

Study Population

In a prospective observational trial we will objectively measure regional distribution of ventilation by EIT in patients who require mechanical ventilation.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Draeger Medical, Inc: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Respiratory Distress Syndrome; Acute Lung Injury; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases; Lung Injury; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brian K Walsh, PhD, RRT

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• John H Arnold, MD

  Boston Children's Hospital

  STUDY DIRECTOR

• Craig Smallwood, BS, RRT

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Jordan Rettig, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Coordinator

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: September 25, 2014
• Study Start: October 1, 2014
• Primary Completion: November 4, 2018
• Study Completion: November 4, 2018
• Last Updated: June 4, 2019

Record last verified: 2019-06

Locations

US (1)