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Retrospective Review of Mechanically Ventilated Patients Using a Continuous Data Collection System. (T3)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Brian Walsh, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT02184208
First received: July 2, 2014
Last updated: August 1, 2016
Last verified: August 2016
  Purpose
Today, the electronic medical record, microprocessor mechanical ventilators, and physiologic monitoring are under-utilized when translating research into decision support. Current medical informatic capabilities can be leveraged to calculate trends in measured parameters to initiate a paradigm shift in critical care from reaction-based treatment to proactive and plausibly preventative care. Therefore, the purpose of this study is to develop baseline understanding of our practice and how data collection utilizing a newly implemented system called T3. We would like to retrospectively review mechanically ventilated patients in which we have collected continuous data to test a newly developed analytic platform. Additionally we would like to compare these results to our standards of practice established by clinical practice guidelines.

Condition
Mechanical Ventilation
Acute Respiratory Distress Syndrome
Hypoxic Respiratory Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Review of Mechanically Ventilated Patients

Resource links provided by NLM:


Further study details as provided by Boston Children’s Hospital:

Primary Outcome Measures:
  • Pulmonary Mechanics [ Time Frame: Continuously until extubated. Usually 5-10 days ]
    Pulmonary mechanics is a composite of many measurements of flow, pressure, volumes, and time.


Secondary Outcome Measures:
  • Successful Extubation [ Time Frame: Within 24 hours of extubation ]

Other Outcome Measures:
  • Patient categorization [ Time Frame: During course of mechanical ventilation. Usually 5-10 ]
    Using continuous data to categorize patient's ventilation and oxygenation categories.


Estimated Enrollment: 50
Study Start Date: July 2014
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Device utlization following extubation
Pulmonary mechanics

  Eligibility

Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All mechanically ventilated patients in our medical surgical ICU.
Criteria

Inclusion Criteria:

  • Patient selection will be determined by available data collected in the T3 system. We estimate 50 patients in which mechanical ventilator data has been collected utilizing the limited intellibridge modules (4 systems currently available to collect ventilator data).

Exclusion Criteria:

  • Patient not connected to T3 data collection system.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02184208

Locations
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian Walsh, Research Coordinator / Research Associate, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT02184208     History of Changes
Other Study ID Numbers: IRB-P000011819
Study First Received: July 2, 2014
Last Updated: August 1, 2016

Keywords provided by Boston Children’s Hospital:
ARDS
ALI
mechanical ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on March 22, 2017