Mechanical Ventilation ComplicationNCT02656199
Change In Diaphragmatic Thickness Predicts Extubation Success
An observational study of Mechanical Ventilation Complication, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
We will investigate whether measurement of the change in thickness of the diaphragm during the respiratory cycle by ultrasound can predict extubation success in a 48 hour window. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Diaphragm Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 13 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on mechanical ventilation in the intensive care unit
Who may be able to join
- age greater than 18, ventilated for >24 hours
Who cannot join
- already chronically on mechanical ventilatory support, already has tracheostomy, has pathology that obscures visualization of the right hemidiaphragm, has acute stroke either hemorrhagic or ischemic, cannot identify appropriate decision maker to get informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
About this study
Official title: Can the Diaphragm Predict the Course of Mechanical Ventilation? A Prospective Study Evaluating Several M-Mode Ultrasound Measured Diaphragmatic Parameters and Their Effects on Weaning From Mechanical Ventilation
We will investigate whether measurement of the change in thickness of the diaphragm during the respiratory cycle by ultrasound can predict extubation success in a 48 hour window. We will also asses whether this is only possible on low levels of pressure support as has been shown previously, or if this technique retains its predictive power at higher levels of pressure support.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Diaphragm Ultrasound
- Keywords
- Diaphragm, Ventilators, Mechanical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaphragm UltrasoundProcedure or surgery
Once on a pressure support weaning trial, enrolled subjects will have an ultrasound of their right hemidiaphragm performed on three levels of pressure support: 15/5 10/5 and 5/5
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort | all patients enrolled will have an ultrasound of their diaphragm performed once they are on a pressure support trial. Intervention: Diaphragm Ultrasound Receives: Procedure: Diaphragm Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extubation Success
Discontinuation from mechanical ventilation in 48 hours from ultrasound
PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.
Measured: 48 hours
Secondary outcomes (1)
Re-intubation
Reinstitution of mechanical ventilation within 48 hours of extubation PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.
Measured: 48 hours from removal of ventilatory support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startJan 2015
- Primary completion13 Jan 2017
- Study completion13 Jan 2017
Why it stopped: IRB approval expired
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.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott Blumhof, DO, Principal investigator, Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656199
- Sponsor's protocol ID
- 4541
- Status last verified
- Jan 2016
- First submitted
- 13 Jan 2016
- Last updated
- 9 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Diaphragm Predict the Course of Mechanical Ventilation? A Prospective Study Evaluating Several M-Mode Ultrasound Measured Diaphragmatic Parameters and Their Effects on Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT02656199
- Acronym / sponsor ID
- 4541
- Conditions
- Mechanical Ventilation Complication
- Keywords
- Diaphragm, Ventilators, Mechanical
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IRB approval expired
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 13 Jan 2017 (actual)
- Study completion
- 13 Jan 2017 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Posted 9 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We will investigate whether measurement of the change in thickness of the diaphragm during the respiratory cycle by ultrasound can predict extubation success in a 48 hour window. We will also asses whether this is only possible on low levels of pressure support as has been shown previously, or if this technique retains its predictive power at higher levels of pressure support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | – | Procedure: Diaphragm Ultrasoundall patients enrolled will have an ultrasound of their diaphragm performed once they are on a pressure support trial. Intervention: Diaphragm Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on mechanical ventilation in the intensive care unit
Key inclusion criteria (1 listed)
- age greater than 18, ventilated for >24 hours
Key exclusion criteria (1 listed)
- already chronically on mechanical ventilatory support, already has tracheostomy, has pathology that obscures visualization of the right hemidiaphragm, has acute stroke either hemorrhagic or ischemic, cannot identify appropriate decision maker to get informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diaphragm UltrasoundOnce on a pressure support weaning trial, enrolled subjects will have an ultrasound of their right hemidiaphragm performed on three levels of pressure support: 15/5 10/5 and 5/5 | Procedure or surgery | Main Cohort |
Primary outcome
Extubation Success
Time frame: 48 hours
Discontinuation from mechanical ventilation in 48 hours from ultrasound PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.
1 secondary outcome
Re-intubation
Time frame: 48 hours from removal of ventilatory support
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Scott Blumhof, DO principal investigator
Einstein Healthcare Network
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 Complication, run by Albert Einstein Healthcare Network 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: stopped early, as of the sponsor's last update on 9 Mar 2020. 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 9 Mar 2020). 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?
Extubation Success (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2020.