Acute Respiratory FailureWEAN-EITNCT05726513
Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation
A study testing Weaning trial - Low support, high Positive end-expiratory pressure, Weaning trial - Low support, zero positive end-expiratory pressure and Weaning trial - Zero support, zero positive end-expiratory pressure in people with Acute Respiratory Failure and Mechanical Ventilation Complication, run by Università degli Studi di Ferrara at 1 site in Italy.
Trial summary
The goal of this physiological cross-over clinical trial is to evaluate the effect of different clinically used weaning trials on regional mechanical ventilation in a population of patients undergoing weaning from mechanical ventilation for acute respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury
- What is being tested?
- Weaning trial - Low support, high Positive end-expiratory pressure, Weaning trial - Low support, zero positive end-expiratory pressure and Weaning trial - Zero support, zero positive end-expiratory pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 15 Feb 2023to 31 Dec 2024
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 and < 70 years
- Ready to be weaned from mechanical ventilation according to clinical criteria
Who cannot join
- Age < 18 years or > 70 years
- Presence of chest drains
- Presence of pacemaker/impantable cardiac device;
- diagnosis of Pneumothorax, or pneumomediastinum
- Diagnois of neuromuscular diseases
- Use of neuromuscular blockers in the 48 hours before screening;
- Body mass index > 35 kg/m2
- Refusal to participate of the patient/next of kin
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Sant'Anna
Ferrara, 44121
Savino Spadaro, MD, +390532239780, savinospadaro@gmail.com
Gaetano Scaramuzzo, MD
About this study
The goal of this physiological cross-over clinical trial is to evaluate the effect of different clinically used weaning trials on regional mechanical ventilation in a population of patients undergoing weaning from mechanical ventilation for acute respiratory failure.
The main question[s] it aims to answer are:
Read more
- to evaluate which weaning trial is associated to a better regional ventilation distribution
- to evaluate which weaning trial can be comparable to ventilation distribution after extubation
Participants will undergo 3 clinically used weaning trials in a random order (cross-over trial). Researchers will compare the different steps to see if regional ventilation distribution is different among the different trial .
- Conditions
- Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury, Weaning Failure
- Being tested
- Weaning trial - Low support, high Positive end-expiratory pressure, Weaning trial - Low support, zero positive end-expiratory pressure, Weaning trial - Zero support, zero positive end-expiratory pressure
- Keywords
- Electrical Impedance tomography, Weaning trial, Acute respiratory failure, Lung monitoring
- Medical subject headings
- Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weaning trial - Low support, high Positive end-expiratory pressureDiagnostic test
The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with low pressure support ventilation and a positive end expiratory pressure of 5 cmH2O
Weaning trial - Low support, zero positive end-expiratory pressureDiagnostic test
The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with low pressure support ventilation and a positive end expiratory pressure of 0 cmH2O
Weaning trial - Zero support, zero positive end-expiratory pressureDiagnostic test
The researcher will evaluate the readiness to be weaned of the patient using a weaning trial with 0 pressure support ventilation and a positive end expiratory pressure of 0 cmH2O
| Study group | Role | What they receive |
|---|---|---|
| Low support, high Positive end-expiratory pressure | Other | Low support, high Positive end-expiratory pressure Receives: Diagnostic Test: Weaning trial - Low support, high Positive end-expiratory pressure |
| Low support, zero positive end-expiratory pressure | Other | Low support, zero positive end-expiratory pressure Receives: Diagnostic Test: Weaning trial - Low support, zero positive end-expiratory pressure |
| Zero support, zero positive end-expiratory pressure | Other | Zero support, zero positive end-expiratory pressure Receives: Diagnostic Test: Weaning trial - Zero support, zero positive end-expiratory pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Ventilation distribution using Electrical Impedance Tomography
The researchers will evaluate differences in ventilation distribution pattern among the different weaning trials using Electrical Impedance Tomography and focusing on:
- Regional ventilation distribution
- Regional inhomogeneity
- Regional compliance distribution
- Center of Ventilation
- Silent Spaces
Measured: 2 hours
Secondary outcomes (1)
Differences in Regional Ventilation distribution using Electrical Impedance Tomography between weaning trials and post-extubation phase
The researchers will evaluate differences in ventilation distribution pattern among the different weaning trials and the post-extubation phase using Electrical Impedance Tomography and focusing on:
- Regional ventilation distribution
- Regional inhomogeneity
- Regional compliance distribution
- Center of Ventilation
- Silent Spaces
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 posted14 Feb 2023
- Study start15 Feb 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milan
- Responsible party
- Principal investigator, Savino Spadaro, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726513
- Sponsor's protocol ID
- WEAN-EIT
- Acronym
- WEAN-EIT
- Status last verified
- Feb 2023
- First submitted
- 13 Jan 2023
- Last updated
- 14 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Regional Ventilation Distribution Using Electrical Impedance Tomography During Weaning From Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05726513
- Acronym / sponsor ID
- WEAN-EIT / WEAN-EIT
- Conditions
- Acute Respiratory Failure, Mechanical Ventilation Complication, Ventilator-Induced Lung Injury, Weaning Failure
- Keywords
- Electrical Impedance tomography, Weaning trial, Acute respiratory failure, Lung monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Collaborators
- University of Milan
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Feb 2023 (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.
The goal of this physiological cross-over clinical trial is to evaluate the effect of different clinically used weaning trials on regional mechanical ventilation in a population of patients undergoing weaning from mechanical ventilation for acute respiratory failure.
The main question[s] it aims to answer are:
- to evaluate which weaning trial is associated to a better regional ventilation distribution
- to evaluate which weaning trial can be comparable to ventilation distribution after extubation
Participants will undergo 3 clinically used weaning trials in a random order (cross-over trial). Researchers will compare the different steps to see if regional ventilation distribution is different among the different trial .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low support, high Positive end-expiratory pressure | Other | Diagnostic Test: Weaning trial - Low support, high Positive end-expiratory pressureLow support, high Positive end-expiratory pressure |
| Low support, zero positive end-expiratory pressure | Other | Diagnostic Test: Weaning trial - Low support, zero positive end-expiratory pressureLow support, zero positive end-expiratory pressure |
| Zero support, zero positive end-expiratory pressure | Other | Diagnostic Test: Weaning trial - Zero support, zero positive end-expiratory pressureZero support, zero positive end-expiratory pressure |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 and < 70 years
- Ready to be weaned from mechanical ventilation according to clinical criteria
Key exclusion criteria (8 listed)
- Age < 18 years or > 70 years
- Presence of chest drains
- Presence of pacemaker/impantable cardiac device;
- diagnosis of Pneumothorax, or pneumomediastinum
- Diagnois of neuromuscular diseases
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 |
|---|---|---|
| Weaning trial - Low support, high Positive end-expiratory pressureThe researcher will evaluate the readiness to be weaned of the patient using a weaning trial with low pressure support ventilation and a positive end expiratory pressure of 5 cmH2O | Diagnostic test | Low support, high Positive end-expiratory pressure |
| Weaning trial - Low support, zero positive end-expiratory pressureThe researcher will evaluate the readiness to be weaned of the patient using a weaning trial with low pressure support ventilation and a positive end expiratory pressure of 0 cmH2O | Diagnostic test | Low support, zero positive end-expiratory pressure |
| Weaning trial - Zero support, zero positive end-expiratory pressureThe researcher will evaluate the readiness to be weaned of the patient using a weaning trial with 0 pressure support ventilation and a positive end expiratory pressure of 0 cmH2O | Diagnostic test | Zero support, zero positive end-expiratory pressure |
Primary outcome
Regional Ventilation distribution using Electrical Impedance Tomography
Time frame: 2 hours
The researchers will evaluate differences in ventilation distribution pattern among the different weaning trials using Electrical Impedance Tomography and focusing on: * Regional ventilation distribution * Regional inhomogeneity * Regional compliance distribution * Center of Ventilation * Silent Spaces
1 secondary outcome
Differences in Regional Ventilation distribution using Electrical Impedance Tomography between weaning trials and post-extubation phase
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weaning trial - Low support, high Positive end-expiratory pressure, Weaning trial - Low support, zero positive end-expiratory pressure and Weaning trial - Zero support, zero positive end-expiratory pressure in people with Acute Respiratory Failure and Mechanical Ventilation Complication, run by Università degli Studi di Ferrara at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Ventilation distribution using Electrical Impedance Tomography (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2023.