NCT02184208

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2016

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2017

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 5, 2018

Completed
Last Updated

February 5, 2018

Status Verified

July 1, 2017

Enrollment Period

3 years

First QC Date

July 2, 2014

Results QC Date

January 30, 2017

Last Update Submit

July 18, 2017

Conditions

Keywords

ARDSALImechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • Successful Extubation

    Successful extubation without the use of noninvasive ventilation or requiring reintubation

    Within 24 hours of extubation

Study Arms (2)

Device utlization following extubation

Pulmonary mechanics

Eligibility Criteria

Age1 Day - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All mechanically ventilated patients in our medical surgical ICU.

You may qualify if:

  • 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).

You may not qualify if:

  • Patient not connected to T3 data collection system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Castineira D, Schlosser KR, Geva A, Rahmani AR, Fiore G, Walsh BK, Smallwood CD, Arnold JH, Santillana M. Adding Continuous Vital Sign Information to Static Clinical Data Improves the Prediction of Length of Stay After Intubation: A Data-Driven Machine Learning Approach. Respir Care. 2020 Sep;65(9):1367-1377. doi: 10.4187/respcare.07561.

  • Walsh BK, Smallwood C, Rettig J, Kacmarek RM, Thompson J, Arnold JH. Daily Goals Formulation and Enhanced Visualization of Mechanical Ventilation Variance Improves Mechanical Ventilation Score. Respir Care. 2017 Mar;62(3):268-278. doi: 10.4187/respcare.04873. Epub 2017 Jan 10.

  • Walsh BK, Smallwood CD, Rettig JS, Thompson JE, Kacmarek RM, Arnold JH. Categorization in Mechanically Ventilated Pediatric Subjects: A Proposed Method to Improve Quality. Respir Care. 2016 Sep;61(9):1168-78. doi: 10.4187/respcare.04723. Epub 2016 Jun 14.

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Results Point of Contact

Title
Brian Kendall Walsh
Organization
Boston Children's Hospital

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Coordinator / Research Associate

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 9, 2014

Study Start

January 17, 2014

Primary Completion

December 30, 2016

Study Completion

January 9, 2017

Last Updated

February 5, 2018

Results First Posted

February 5, 2018

Record last verified: 2017-07

Locations