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Speckle Tracking Echocardiography for the Prediction of Weaning Failure

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ClinicalTrials.gov Identifier: NCT03657524
Recruitment Status : Not yet recruiting
First Posted : September 5, 2018
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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.

Condition or disease Intervention/treatment Phase
Weaning Failure of Mechanical Ventilation Other: echocardiography Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Combined Thoracic Ultrasound Using Speckle Tracking for the Prediction of Weaning Failure : a Prospective Multicenter Study
Estimated Study Start Date : November 2, 2018
Estimated Primary Completion Date : November 2, 2019
Estimated Study Completion Date : November 2, 2021

Arm Intervention/treatment
Experimental: Resuscitation patients Other: echocardiography
Speckle tracking echocardiography

Active Comparator: healthy volunteers Other: echocardiography
Speckle tracking echocardiography




Primary Outcome Measures :
  1. lung and heart ultrasounds [ Time Frame: Just before and during the weaning trial ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03657524


Contacts
Contact: Laurent ZIELESKIEWICZ 04 91 96 53 77 laurent.zieleskiewicz@ap-hm.fr

Locations
France
Assistance Publique Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13015
Contact: Laurent ZIELESKIEWICZ    04 91 96 53 77    laurent.zieleskiewicz@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Jean-Olivier ARNAUD Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03657524     History of Changes
Other Study ID Numbers: 2018-34
First Posted: September 5, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No