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

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ClinicalTrials.gov Identifier: NCT02184208
Recruitment Status : Completed
First Posted : July 9, 2014
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Brian Walsh, Boston Children's Hospital

Study Description
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Brief Summary:
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 or disease
Mechanical Ventilation Acute Respiratory Distress Syndrome Hypoxic Respiratory Failure

Study Design
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Study Type : Observational
Actual Enrollment : 278 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Review of Mechanically Ventilated Patients
Actual Study Start Date : January 17, 2014
Actual Primary Completion Date : December 30, 2016
Actual Study Completion Date : January 9, 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Device utlization following extubation
Pulmonary mechanics


Outcome Measures
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Primary Outcome Measures :
  1. Successful Extubation [ Time Frame: Within 24 hours of extubation ]
    Successful extubation without the use of noninvasive ventilation or requiring reintubation


Eligibility Criteria
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Ages Eligible for Study:   1 Day 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
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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): NCT02184208


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Brian Walsh, Research Coordinator / Research Associate, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT02184208    
Other Study ID Numbers: IRB-P000011819
First Posted: July 9, 2014    Key Record Dates
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018
Last Verified: July 2017
Keywords provided by Brian Walsh, Boston Children's Hospital:
ARDS
ALI
mechanical ventilation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Acute Lung Injury
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury