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

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ClinicalTrials.gov Identifier: NCT02247700
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Draeger Medical, Inc
Information provided by (Responsible Party):
Brian Walsh, Boston Children’s Hospital

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.

Condition or disease
Respiratory Failure Acute Respiratory Distress Syndrome Acute Lung Injury

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Cohort Study of Distribution of Ventilation in Infants and Children Requiring Mechanical Ventilation by Electrical Impedance Tomography
Actual Study Start Date : October 1, 2014
Actual Primary Completion Date : November 4, 2018
Actual Study Completion Date : November 4, 2018


Group/Cohort
Mechanical Ventilation
Infants and Children requiring mechanical ventilation



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Distribution of Ventilation Changes Over Time [ Time Frame: Every 24 hours for the duration of mechanical ventilation ]
    Changes if the distribution pattern over time


Other Outcome Measures:
  1. EIT Guided Ventilation Algorithms [ Time Frame: Images pre change in PEEP compared to post change ]
    Comparision of distribution of ventilation algorithms



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247700


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Draeger Medical, Inc
Investigators
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Principal Investigator: Brian K Walsh, PhD, RRT Boston Children’s Hospital
Study Director: John H Arnold, MD Boston Children’s Hospital
Principal Investigator: Craig Smallwood, BS, RRT Boston Children’s Hospital
Principal Investigator: Jordan Rettig, MD Boston Children’s Hospital

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Responsible Party: Brian Walsh, Research Coordinator, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02247700     History of Changes
Other Study ID Numbers: IRB-P00013295
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Keywords provided by Brian Walsh, Boston Children’s Hospital:
Pediatrics
ARDS
ARF
ALI
Respiratory
Mechanical ventilation
Ventilation
Noninvasive monitoring
electrical impedance tomography
EIT
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries