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

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 Overview

• Status: Terminated
• Conditions: Mechanical Ventilation Complication
• Intervention / Treatment: Procedure: Diaphragm Ultrasound

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients on mechanical ventilation in the intensive care unit

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main Cohort; all patients enrolled will have an ultrasound of their diaphragm performed once they are on a pressure support trial. Intervention: Diaphragm Ultrasound	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network
• Investigators: Principal Investigator: Scott Blumhof, DO, Einstein Healthcare Network

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): January 13, 2017
• Study Completion (Actual): January 13, 2017

Study Registration Dates

• First Submitted: January 13, 2016
• First Submitted That Met QC Criteria: January 13, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Diaphragm; Ventilators, Mechanical
• Other Study ID Numbers: 4541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO