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Ultrasonography for Prediction of Extubation Success: a Holistic Approach (APEX)

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ClinicalTrials.gov Identifier: NCT04196361
Recruitment Status : Completed
First Posted : December 12, 2019
Last Update Posted : December 12, 2019
Information provided by (Responsible Party):
Jasper M Smit, MD, Amsterdam UMC, location VUmc

Brief Summary:
This study evaluates thickening fraction alone and together with other ultrasound parameters of heart and lungs as predictors for extubation outcome

Condition or disease Intervention/treatment
Exutbation Failure Mechanical Ventilation Diagnostic Test: Ultrasound

Detailed Description:

Weaning patients in the intensive care unit (ICU) from the mechanical ventilator is a critical period and accounts for 40% of the duration of mechanical ventilation itself. Weaning failure includes failing the initial spontaneous breathing trial (SBT) and patients with extubation failure. Extubation failure is defined as reintubation or need for rescue non-invasive ventilation within 48 hours following extubation. Patients failing extubation experience increased time spent on the mechanical ventilator and even increased mortality rates. Given these risks, predicting readiness for extubation is of key importance in the ICU.

Studies have shown, that US is a viable tool for routine use due to its bedside availability and non-invasiveness, while still maintaining excellent predictive values for its respective applications. For this reason, over the past years, critical care ultrasonography (US) has become an important part of routine bedside assessment Lately, the diaphragm has been studied extensively, due to its strong role in sustaining spontaneous breathing. Especially predicting extubation outcomes

has become a great field of interest and different studies have been conducted on this topic. Currently, indices such as diaphragm thickening (Tdi), diaphragm thickness (Tdi%) and diaphragm motion are the most frequently used parameters. Of these, thickening fraction seems to be the most promising to predict successful extubation.

However, all of the studies conducted, solely looked at diaphragm function and compared them to current standards such as the rapid shallow breathing index, while disregarding other factors strongly correlated to extubation failure, e.g. respiratory and cardiac function, as proposed by Mayo et al. Taking heart and lung function into account as well seems to be an interesting approach, because additional measurements could possibly improve predictive value while putting no further burden on the patient. Furthermore, both heart and lungs can be assessed quickly and easily by ultrasound. Cardiac parameters that are potentially useful are left ventricular function, mitral diastolic inflow and cardiac output. Regarding the lungs, pleural effusion is associated with rate of success for extubation. Effusion is detected easily and recent studies have shown, that in an ICU setting a simple 8 region protocol is sufficient to detect extra vascular lung water.

The investigators hypothesise that a holistic US approach, including measurements of heart, lungs and diaphragm, will be superior to the core diagnostic parameters of the diaphragm in predicting extubation success in mechanically ventilated critical care patients.

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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasonography for Prediction of Extubation Success: a Holistic Approach
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : November 29, 2019
Actual Study Completion Date : December 2, 2019

Group/Cohort Intervention/treatment
Patient that were ventilated for at least 72 hours
Diagnostic Test: Ultrasound
Point of care ultrasound as part of routine physical examination

Primary Outcome Measures :
  1. Sensitivity [ Time Frame: 48 hours ]
    Sensitivity of thickening fraction for extubation failure

  2. Specificity [ Time Frame: 48 hours ]
    Specificity of thickening fraction for extubation failure

  3. Area under the Curve [ Time Frame: 48 hours ]
    Area under the receiver operator curve

  4. Correlation of ultrasound variables with extubation outcome [ Time Frame: 48 hours ]
    Correlation of ultrasound variables with extubation outcome through (logistic)regression analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population consisted of adult (>18 years) patients, admitted to the ICU and ventilated for at least 72h.

Inclusion Criteria:

  • Ventilated for > 72 hours
  • Passed spontaneous breathing trial

Exclusion Criteria:

  • Planned NIV
  • Palliative Extubation
  • Tracheostomy
  • Paraplegia above Th 8
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jasper M Smit, MD, Medical Doctor, Amsterdam UMC, location VUmc
ClinicalTrials.gov Identifier: NCT04196361    
Other Study ID Numbers: 2016.465
First Posted: December 12, 2019    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon we request we can share our data to assist other researchers with interest in this field of research.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After publication in a peer reviewed journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jasper M Smit, MD, Amsterdam UMC, location VUmc: