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Change In Diaphragmatic Thickness Predicts Extubation Success

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02656199
Enrollment
57
Registered
2016-01-14
Start date
2015-01-31
Completion date
2017-01-13
Last updated
2020-03-09

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

Conditions

Mechanical Ventilation Complication

Keywords

Diaphragm, Ventilators, Mechanical

Brief 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. 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.

Interventions

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

Sponsors

Albert Einstein Healthcare Network
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age greater than 18, ventilated for \>24 hours

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Extubation Success48 hoursDiscontinuation 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.

Secondary

MeasureTime frameDescription
Re-intubation48 hours from removal of ventilatory supportReinstitution 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.

Countries

United States

Participant flow

Recruitment details

0 participants analyzed. PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.

Pre-assignment details

0 participants analyzed. PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.

Participants by arm

ArmCount
Main Cohort
all patients enrolled will have an ultrasound of their diaphragm performed once they are on a pressure support trial. Intervention: Diaphragm Ultrasound Diaphragm Ultrasound: 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 PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.
0
Total0

Baseline characteristics

Characteristic
Region of Enrollment
United States
— participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

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.

Time frame: 48 hours

Population: PI has left the institution. Efforts made to contact the PI were unsuccessful. No study data available.

Secondary

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.

Time frame: 48 hours from removal of ventilatory support

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026