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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03657524
Other study ID # 2018-34
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2, 2018
Est. completion date November 2, 2021

Study information

Verified date August 2018
Source Assistance Publique Hopitaux De Marseille
Contact Laurent ZIELESKIEWICZ
Phone 04 91 96 53 77
Email laurent.zieleskiewicz@ap-hm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Deciding the optimal timing for extubation in patients who are mechanically ventilated can be challenging, and traditional weaning predictor tools are not accurate. Recent studies suggest that isolated sonographic assessment of the respiratory and cardiac function (ie diastolic function and filling pressure), in mechanically ventilated patients may assist in identifying patients at risk of weaning failure. Recently, the association of conventional echocardiography and lung ultrasound showed promising results for the prediction of post extubation distress. Speckle Tracking is an emerging tool in intensive care medicine that has never been investiguated for the prediction of weaning failure. It could early detects diastolic dysfunction and and elevated filling pressure. Of more, speckle tracking is known to be less operator dependant. The main objective of our study is to evaluate the diagnosis accuracy of speckle tracking echocardiography performed during a weaning trial to predict weaning failure. The secondary objectives are to assess the diagnosis accuracy of combined heart and lung ultrasound to predict weaning failure.


Description:

Deciding the optimal timing for extubation in patients who are mechanically ventilated can be challenging, and traditional weaning predictor tools are not accurate. Recent studies suggest that isolated sonographic assessment of the respiratory and cardiac function (ie diastolic function and filling pressure), in mechanically ventilated patients may assist in identifying patients at risk of weaning failure. Recently, the association of conventional echocardiography and lung ultrasound showed promising results for the prediction of post extubation distress. Speckle Tracking is an emerging tool in intensive care medicine that has never been investiguated for the prediction of weaning failure. It could early detects diastolic dysfunction and and elevated filling pressure. Of more, speckle tracking is known to be less operator dependant. The main objective of our study is to evaluate the diagnosis accuracy of speckle tracking echocardiography performed during a weaning trial to predict weaning failure. The secondary objectives are to assess the diagnosis accuracy of combined heart and lung ultrasound to predict weaning failure.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 110
Est. completion date November 2, 2021
Est. primary completion date November 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients hospitalized in intensive care unit under mechanical fulfilling the criteria of ventilation weaning trial.

Exclusion Criteria:

- Less than 18 years old.

- Pregnancy

- Non sinusal cardiac rhythm

- Neuro Myopathy

- Tracheotomy

- Lack of echogenicity to perform at least a four chamber apical view

Study Design


Related Conditions & MeSH terms

  • Weaning Failure of Mechanical Ventilation

Intervention

Other:
echocardiography
Speckle tracking echocardiography

Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary lung and heart ultrasounds Area under the receiver operator characteristic curve (AUC) of global longitudinal strain and strain rate variations (before and during a weaning trial) to predict weaning failure. Just before and during the weaning trial