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

Retrospective Review of Mechanically Ventilated Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02184208
Acronym
T3
Enrollment
278
Registered
2014-07-09
Start date
2014-01-17
Completion date
2017-01-09
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome, Hypoxic Respiratory Failure, Mechanical Ventilation

Keywords

ARDS, ALI, mechanical ventilation

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.

Interventions

None listed

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Successful ExtubationWithin 24 hours of extubationSuccessful extubation without the use of noninvasive ventilation or requiring reintubation

Countries

United States

Participant flow

Participants by arm

ArmCount
Patient Categorization
We retrospectively categorized the ventilation and oxygenation statuses of patients within our PICU utilizing 15 rules based algorithms. Targets were predetermined based on generally accepted practices. All patient categories were calculated and presented as a percent score (0-100%) of acceptable ventilation, acceptable oxygenation, barotrauma free and volutrauma free states.
222
Total222

Baseline characteristics

CharacteristicPatient Categorization
Age, Continuous3 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
9 Participants
Race (NIH/OMB)
Black or African American
17 Participants
Race (NIH/OMB)
More than one race
33 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
42 Participants
Race (NIH/OMB)
White
120 Participants
Region of Enrollment
United States
222 participants
Sex: Female, Male
Female
82 Participants
Sex: Female, Male
Male
140 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
9 / 10420 / 222
other
Total, other adverse events
0 / 1040 / 222
serious
Total, serious adverse events
0 / 1040 / 222

Outcome results

Primary

Successful Extubation

Successful extubation without the use of noninvasive ventilation or requiring reintubation

Time frame: Within 24 hours of extubation

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Device Utlization Following ExtubationSuccessful Extubation58 Participants
Pulmonary MechanicsSuccessful Extubation222 Participants

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026