MedTrace Logo

Use of Transient Elastogaphy to Assess Diaphragm Function in Mechanically Ventilated Patients

NCT03832231 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-03-01

No results posted yet for this study

Summary

Mechanical ventilation is a life-saving treatment that can be associated with diaphragm dysfunction, a potentially deleterious acquired disability. It may be the consequence of disuse - under mechanical ventilation, respiratory muscles are unloaded - or the consequence of muscle overuse because of insufficient unloading. Evaluating diaphragm function is therefore crucial to optimally tailor the ventilator assistance. Measurement of transdiaphragmatic pressure (Pdi) is the reference method to assess diaphragm function but it invasiveness hinders the generalization of its use. Previous studies have reported that ultrasound can quantify diaphragm thickening and that diaphragm thickening fraction (TFdi) is a good marker of diaphragm function. Since diaphragm becomes stiffer when it contracts, the investigators aim at exploring whether the measurement of diaphragm stiffness by transient shear wave elastography would improve the evaluation of diaphragm function with ultrasound.

Therefore, the objectives of the study are to evaluate the performance of transient shear wave elastography applied to the diaphragm to estimate Pdi in mechanically ventilated patients as compared to TFdi and to correlate the changes in elastography derived indices, in TFdi and in Pdi into different ventilatory conditions and during a spontaneous breathing trial. Pdi will be obtained using catheters positioned in patients' stomachs and esophagus and diaphragm stiffness will be assessed by measuring the shear modulus of the diaphragm with a dedicated ultrasound machine (Aixplorer, Ultrasonic). TFdi will be also measured as previously reported. Pdi, TFdi and shear modulus will be measured at the end of each four following 10 minutes-conditions: 1) baseline with initial ventilator settings (set by the physician in charge of patient); 2) 25%-increase in pressure support and initial PEEP; 3) 25%-decrease in pressure support and initial PEEP and 4) initial level of pressure support and ZEEP. Finally, the same measurements will be done at the beginning of a 30 minutes spontaneous breathing trial.

Conditions

  • Ventilator Weaning
  • Intensive Care Unit

Interventions

DEVICE

Shear Wave Elastography

Ultrasound technology to assess tissue stiffness

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Martin DRES, MD, PhD · Assistance Publique Hoptiaux de Paris

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-14
Primary Completion
2019-02-15
Completion
2020-07-09

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03832231 on ClinicalTrials.gov