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Exutbation FailureAPEXNCT04196361

Ultrasonography for Prediction of Extubation Success: a Holistic Approach

An observational study of Exutbation Failure and Mechanical Ventilation, run by Amsterdam UMC, location VUmc.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates thickening fraction alone and together with other ultrasound parameters of heart and lungs as predictors for extubation outcome Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Exutbation Failure, Mechanical Ventilation
What is being tested?
Ultrasound
How many people
83 participants
Where
No sites listed yet
Study dates
1 Sep 2016to 2 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consisted of adult (>18 years) patients, admitted to the ICU and ventilated for at least 72h.

Who may be able to join

  • Ventilated for > 72 hours
  • Passed spontaneous breathing trial

Who cannot join

  • Planned NIV
  • Palliative Extubation
  • Tracheostomy
  • Paraplegia above Th 8

About this study

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

Read the 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.

Being tested
Ultrasound
Keywords
Ultrasound, Diaphragm, Holistic, Extubation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundDiagnostic test

    Point of care ultrasound as part of routine physical examination

Study groups in NCT04196361
Study groupRoleWhat they receive
Ventilated72hPatient that were ventilated for at least 72 hours
Receives: Diagnostic Test: Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensitivity

    Sensitivity of thickening fraction for extubation failure

    Measured: 48 hours

  2. Specificity

    Specificity of thickening fraction for extubation failure

    Measured: 48 hours

  3. Area under the Curve

    Area under the receiver operator curve

    Measured: 48 hours

  4. Correlation of ultrasound variables with extubation outcome

    Correlation of ultrasound variables with extubation outcome through (logistic)regression analysis.

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2019
  2. Study start1 Sep 2016
  3. Primary completion29 Nov 2019
  4. Study completion2 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04196361
Sponsor's protocol ID
2016.465
Acronym
APEX
Status last verified
Dec 2019
First submitted
9 Dec 2019
Last updated
12 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Upon we request we can share our data to assist other researchers with interest in this field of research.

Publications

  • Haaksma ME, Smit JM, Heldeweg M, Nooitgedacht JS, Atmowihardjo LN, Jonkman AH, de Vries HJ, Lim EH, Steenvoorden T, Lust E, Girbes AR, Heunks LM, Tuinman PR. Holistic Ultrasound to Predict Extubation Failure in Clinical Practice. Respir Care. 2021 Jun;66(6):994-1003. doi: 10.4187/respcare.08679. Epub 2021 Apr 13.

    PubMed 33850048

Questions about this trial

What is this clinical trial studying?

An observational study of Exutbation Failure and Mechanical Ventilation, run by Amsterdam UMC, location VUmc.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity (time frame: 48 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04196361, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2019.

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