Change In Diaphragmatic Thickness Predicts Extubation Success

Mechanical Ventilation Complication Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02656199
• Other study ID #: 4541
• Status: Terminated
• Start date: January 2015
• Est. completion date: January 13, 2017

Study information

• Verified date: January 2016
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 57
• Est. completion date: January 13, 2017
• Est. primary completion date: January 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mechanical Ventilation Complication

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Einstein Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	48 hours
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.	48 hours from removal of ventilatory support