Mechanical VentilationT3NCT02184208
Retrospective Review of Mechanically Ventilated Patients Using a Continuous Data Collection System.
An observational study of Mechanical Ventilation and Acute Respiratory Distress Syndrome, run by Boston Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 35 years
- Conditions the study is for
- Mechanical Ventilation, Acute Respiratory Distress Syndrome, Hypoxic Respiratory Failure
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2014to 9 Jan 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All mechanically ventilated patients in our medical surgical ICU.
Who may be able to join
- 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).
Who cannot join
- Patient not connected to T3 data collection system.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Retrospective Review of Mechanically Ventilated Patients
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.
- Keywords
- ARDS, ALI, mechanical ventilation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Device utlization following extubation | Not described | |
| Pulmonary mechanics | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Extubation
Successful extubation without the use of noninvasive ventilation or requiring reintubation
Measured: Within 24 hours of extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study start17 Jan 2014
- Primary completion30 Dec 2016
- Study completion9 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Walsh, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184208
- Sponsor's protocol ID
- IRB-P000011819
- Acronym
- T3
- Status last verified
- Jul 2017
- First submitted
- 2 Jul 2014
- Last updated
- 5 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32879034Walsh 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.
PubMed 28073993Walsh 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.
PubMed 27303050
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Mechanically Ventilated Patients
- ClinicalTrials.gov ID
- NCT02184208
- Acronym / sponsor ID
- T3 / IRB-P000011819
- Keywords
- ARDS, ALI, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 17 Jan 2014 (actual)
- Primary completion
- 30 Dec 2016 (actual)
- Study completion
- 9 Jan 2017 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Posted 5 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device utlization following extubation | – | – |
| Pulmonary mechanics | – | – |
Who may qualify
- Ages
- 1 day to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All mechanically ventilated patients in our medical surgical ICU.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- Patient not connected to T3 data collection system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Successful Extubation
Time frame: Within 24 hours of extubation
Successful extubation without the use of noninvasive ventilation or requiring reintubation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32879034Castineira 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.
- Derived from this study: PubMed 28073993Walsh 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.
- Derived from this study: PubMed 27303050Walsh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Acute Respiratory Distress Syndrome, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Extubation (time frame: Within 24 hours of extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02184208, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.