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.
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.
- Conditions
- Exutbation Failure, Mechanical Ventilation
- 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 group | Role | What they receive |
|---|---|---|
| Ventilated72h | Patient 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.
Sensitivity
Sensitivity of thickening fraction for extubation failure
Measured: 48 hours
Specificity
Specificity of thickening fraction for extubation failure
Measured: 48 hours
Area under the Curve
Area under the receiver operator curve
Measured: 48 hours
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.
- First posted12 Dec 2019
- Study start1 Sep 2016
- Primary completion29 Nov 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exutbation FailureStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasper M Smit, MD, Amsterdam UMC, location VUmc
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography for Prediction of Extubation Success: a Holistic Approach
- ClinicalTrials.gov ID
- NCT04196361
- Acronym / sponsor ID
- APEX / 2016.465
- Conditions
- Exutbation Failure, Mechanical Ventilation
- Keywords
- Ultrasound, Diaphragm, Holistic, Extubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates thickening fraction alone and together with other ultrasound parameters of heart and lungs as predictors for extubation outcome
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ventilated72h | – | Diagnostic Test: UltrasoundPatient that were ventilated for at least 72 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult (>18 years) patients, admitted to the ICU and ventilated for at least 72h.
Key inclusion criteria (2 listed)
- Ventilated for > 72 hours
- Passed spontaneous breathing trial
Key exclusion criteria (4 listed)
- Planned NIV
- Palliative Extubation
- Tracheostomy
- Paraplegia above Th 8
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundPoint of care ultrasound as part of routine physical examination | Diagnostic test | Ventilated72h |
Primary outcome
Sensitivity
Time frame: 48 hours
Sensitivity of thickening fraction for extubation failure
Specificity
Time frame: 48 hours
Specificity of thickening fraction for extubation failure
Area under the Curve
Time frame: 48 hours
Area under the receiver operator curve
Correlation of ultrasound variables with extubation outcome
Time frame: 48 hours
Correlation of ultrasound variables with extubation outcome through (logistic)regression analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Derived from this study: PubMed 33850048Haaksma 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.
- Individual participant dataSharing planned: Yes. Upon we request we can share our data to assist other researchers with interest in this field of research.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.