Mechanical Ventilation WeaningNCT05539599
Comprehensive Ultrasound Evaluation as a Predictor of Weaning
An observational study of Mechanical Ventilation Weaning and Weaning Failure, run by Università degli Studi di Ferrara at 2 sites in Italy.
Trial summary
Several studies investigated the role of specific clinical predictors of weaning success, but it is determined by a combination of different aspects that can result in success or failure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Mechanical Ventilation Weaning, Weaning Failure
- What is being tested?
- Comprehensive evaluation
- How many people
- 89 participants
- Where
- 2 sitesItaly
- Study dates
- 9 Sep 2022to 8 May 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: mechanically ventilated patients
Who may be able to join
- aged between 18 and 90 years
- Mechanical ventilation> 48 h
- Reason for ICU admission: medical / surgical / trauma
Who cannot join
- age under 18
- diagnosis of neuromuscular disease
- tracheostomy
- terminal extubation
- pregnancy in progress -
- previous paralysis of the diaphragm or of a hemidiaphragm
- use of neuromuscular blocking drugs in continuous infusion in the 48 hours preceding the weaning attempt.
- Refusal to participate in the study
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Università di Ferrara
Ferrara, 44121
Università di Siena
Siena, 53100
About this study
Official title: Can Heart-lung-respiratory Muscles Ultrasound Evaluation Play a Role to Predict Weaning in Critically Ill Patients?
Several studies investigated the role of specific clinical predictors of weaning success, but it is determined by a combination of different aspects that can result in success or failure. Indeed, unresolved lung disease, cardiac dysfunction, loss of respiratory and core muscle strength can play a role in a failure weaning to mechanical ventilation (MV). The investigators hypothesized that a combined score that include heart, lung, and respiratory muscle ultrasound (US) evaluation could be able to predict the ability of weaning success. Furthermore, it will be described weather the days of MV before weaning trial may affect the relevance of each clinical variable evaluated.
Read the detailed description
Critically ill patients undergone at least 48 hours of MV and ready to spontaneous breathing trial (SBT) will be included in the study. The spontaneous breathing trial is performed in pressure support ventilation with a clinician-set positive end expiratory pressure (PEEP) ≤ 5 cm H2O and FiO2< 40%. In addition to the parameters traditionally used for the evaluation of weaning (RSBI), the investigators will perform ultrasound evaluation of diaphragm, lung parenchyma, cardiac function, and the strength of the hand grip.
Investigators will evaluate the diaphragmatic parameters (thickening fraction,TF, and diaphragmatic displacement, DD) and TFmax (TF during forced breathing /TF during tidal respiration) to identify the inspiratory reserve. Weaning success is considered as liberation from MV within 72 hours.
- Conditions
- Mechanical Ventilation Weaning, Weaning Failure
- Being tested
- Comprehensive evaluation
- Keywords
- weaning, MV critically ill patients, Ultrasound evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive evaluationDiagnostic test
Non-ultrasound parameters: Central venous pressure, hand-grip strength evaluation, P0.1, Maximal inspiratory pressure, Blood gas analysis ultrasound parameters: Diaphragmatic displacement, thickening fraction, TFmax, E/e', Triscuspidal annular Plane Systolic Excursion, Lung score
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patients will undergo a spontaneous breathing trial. Any extubation will be decided by an independent operator. Receives: Diagnostic Test: Comprehensive evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the prognostic value of a combined score in predicting weaning success
We hypothesized that a combined score that include heart, lung, and respiratory muscle ultrasound (US) evaluation could be able to predict the ability of weaning success.
Measured: 72 hours
Secondary outcomes (1)
Interaction between days of mechanical ventilator and determinant of weaning success
We will assess the interaction between days of mechanical ventilation and the prognostic value of Central venous pressure, hand-grip strength evaluation, P0.1, Maximal inspiratory pressure, Blood gas analysis, Diaphragmatic displacement, thickening fraction, TFmax, E/e', Triscuspidal annular Plane Systolic Excursion, Lung score in predicting weaning success
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start9 Sep 2022
- Primary completion2 May 2024
- Study completion8 May 2024
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 Mechanical Ventilation WeaningStudies of the same condition, open and under way.
- 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
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Fogagnolo, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05539599
- Sponsor's protocol ID
- WEAN_US
- Status last verified
- May 2024
- First submitted
- 8 Sep 2022
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fogagnolo A, Dres M, Murgolo F, Grasso S, Brazzoli B, Pasa G, Khan MR, Azzolina D, Alvisi V, Scaramuzzo G, Volta CA, Spadaro S. Integrated comprehensive assessment for predicting weaning success in difficult-to-wean critically ill patients: the WEAN-US study. Crit Care. 2026 Jun 4;30(1):309. doi: 10.1186/s13054-026-06113-7.
PubMed 42243858
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Heart-lung-respiratory Muscles Ultrasound Evaluation Play a Role to Predict Weaning in Critically Ill Patients?
- ClinicalTrials.gov ID
- NCT05539599
- Acronym / sponsor ID
- WEAN_US
- Conditions
- Mechanical Ventilation Weaning, Weaning Failure
- Keywords
- weaning, MV critically ill patients, Ultrasound evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 14 Sep 2022 (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.
Several studies investigated the role of specific clinical predictors of weaning success, but it is determined by a combination of different aspects that can result in success or failure. Indeed, unresolved lung disease, cardiac dysfunction, loss of respiratory and core muscle strength can play a role in a failure weaning to mechanical ventilation (MV). The investigators hypothesized that a combined score that include heart, lung, and respiratory muscle ultrasound (US) evaluation could be able to predict the ability of weaning success. Furthermore, it will be described weather the days of MV before weaning trial may affect the relevance of each clinical variable evaluated.
Detailed description
Critically ill patients undergone at least 48 hours of MV and ready to spontaneous breathing trial (SBT) will be included in the study. The spontaneous breathing trial is performed in pressure support ventilation with a clinician-set positive end expiratory pressure (PEEP) ≤ 5 cm H2O and FiO2< 40%. In addition to the parameters traditionally used for the evaluation of weaning (RSBI), the investigators will perform ultrasound evaluation of diaphragm, lung parenchyma, cardiac function, and the strength of the hand grip.
Investigators will evaluate the diaphragmatic parameters (thickening fraction,TF, and diaphragmatic displacement, DD) and TFmax (TF during forced breathing /TF during tidal respiration) to identify the inspiratory reserve. Weaning success is considered as liberation from MV within 72 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Diagnostic Test: Comprehensive evaluationPatients will undergo a spontaneous breathing trial. Any extubation will be decided by an independent operator. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mechanically ventilated patients
Key inclusion criteria (3 listed)
- aged between 18 and 90 years
- Mechanical ventilation> 48 h
- Reason for ICU admission: medical / surgical / trauma
Key exclusion criteria (8 listed)
- age under 18
- diagnosis of neuromuscular disease
- tracheostomy
- terminal extubation
- pregnancy in progress -
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 |
|---|---|---|
| Comprehensive evaluationNon-ultrasound parameters: Central venous pressure, hand-grip strength evaluation, P0.1, Maximal inspiratory pressure, Blood gas analysis ultrasound parameters: Diaphragmatic displacement, thickening fraction, TFmax, E/e', Triscuspidal annular Plane Systolic Excursion, Lung score | Diagnostic test | Cohort |
Primary outcome
Assessing the prognostic value of a combined score in predicting weaning success
Time frame: 72 hours
We hypothesized that a combined score that include heart, lung, and respiratory muscle ultrasound (US) evaluation could be able to predict the ability of weaning success.
1 secondary outcome
Interaction between days of mechanical ventilator and determinant of weaning success
Time frame: 28 days
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 9 May 2024.
- Derived from this study: PubMed 42243858Fogagnolo A, Dres M, Murgolo F, Grasso S, Brazzoli B, Pasa G, Khan MR, Azzolina D, Alvisi V, Scaramuzzo G, Volta CA, Spadaro S. Integrated comprehensive assessment for predicting weaning success in difficult-to-wean critically ill patients: the WEAN-US study. Crit Care. 2026 Jun 4;30(1):309. doi: 10.1186/s13054-026-06113-7.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Weaning and Weaning Failure, run by Università degli Studi di Ferrara at 2 sites in Italy.
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 3 inclusion and 8 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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Assessing the prognostic value of a combined score in predicting weaning success (time frame: 72 hours). 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 NCT05539599, 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 9 May 2024.