WeaningNCT03091413
Correlation Between Pi Max and Diaphragm Maximum Inspiratory Excursion Detected With Ultrasound During Weaning
An observational study of Weaning and Diaphragm Ultrasound, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
This study evaluates the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound during the weaning from invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning, Diaphragm Ultrasound, Maximum Inspiratory Pressure
- What is being tested?
- diaphragm ultrasound
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 4 Apr 2022to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All ICU patients of Hospital de Sabadell who meet criteria for weaning will be included in the study.
Who may be able to join
- Age > 18 years.
- Invasive Mechanical Ventilation > 24 hours.
- Readiness for weaning (following clinician decision made according to recent guidelines).
Who cannot join
- Impossibility to perform an echography.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound during the weaning from invasive mechanical ventilation.
- Conditions
- Weaning, Diaphragm Ultrasound, Maximum Inspiratory Pressure
- Being tested
- diaphragm ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragm ultrasoundDiagnostic test
For each patient intubated and ventilated in our ICU we will performed diaphragm ultrasound during the weaning process.
We will performed the measurement of diaphragmatic maximum excursion during a maximal inspiration using an abdominal standard preset with M-mode, with the so called anatomical M-mode.
We will put the probe in the right subcostal window to use the hepatic window to assess the movement of the diaphragm. We will performed the measure of the diaphragm excursion with patient in semi-recumbent position and through a transhepatic transverse oblique scan while the patient is on mechanical ventilation and undergo a Pimax maneuver, that consists in a temporary occlusion of the airway with an expiratory pause.
We will performed the measure three times, and we will take into account the best one made by the patient.
| Study group | Role | What they receive |
|---|---|---|
| case group | diaphragm ultrasounds during weaning and Pimax measures Receives: Diagnostic Test: diaphragm ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pimax and diaphragm inspiratory excursion
To assess the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound.
Measured: 4 months
Secondary outcomes (2)
Predicting value of diaphragm excursion
To assess the predicting value of the diaphragm maximum inspiratory excursion measured with ultrasound for the weaning success.
Measured: 4 months
Combination index prediction for weaning
To assess if the diaphragm maximum inspiratory excursion measured with ultrasound alone or in combination with other index (RSBI, Δtdi%) can predict the weaning success.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start4 Apr 2022
- Primary completion1 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: not recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candelaria de Haro, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091413
- Sponsor's protocol ID
- ECO-MIP
- Status last verified
- Feb 2024
- First submitted
- 21 Mar 2017
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Pi Max and Diaphragm Maximum Inspiratory Excursion Detected With Ultrasound During Weaning
- ClinicalTrials.gov ID
- NCT03091413
- Acronym / sponsor ID
- ECO-MIP
- Conditions
- Weaning, Diaphragm Ultrasound, Maximum Inspiratory Pressure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: not recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Mar 2017 (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 the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound during the weaning from invasive mechanical ventilation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: diaphragm ultrasounddiaphragm ultrasounds during weaning and Pimax measures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All ICU patients of Hospital de Sabadell who meet criteria for weaning will be included in the study.
Key inclusion criteria (3 listed)
- Age > 18 years.
- Invasive Mechanical Ventilation > 24 hours.
- Readiness for weaning (following clinician decision made according to recent guidelines).
Key exclusion criteria (1 listed)
- Impossibility to perform an echography.
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 |
|---|---|---|
| diaphragm ultrasoundFor each patient intubated and ventilated in our ICU we will performed diaphragm ultrasound during the weaning process. We will performed the measurement of diaphragmatic maximum excursion during a maximal inspiration using an abdominal standard preset with M-mode, with the so called anatomical M-mode. We will put the probe in the right subcostal window to use the hepatic window to assess the movement of the diaphragm. We will performed the measure of the diaphragm excursion with patient in semi-recumbent position and through a transhepatic transverse oblique scan while the patient is on mechanical ventilation and undergo a Pimax maneuver, that consists in a temporary occlusion of the airway with an expiratory pause. We will performed the measure three times, and we will take into account the best one made by the patient. | Diagnostic test | case group |
Primary outcome
Pimax and diaphragm inspiratory excursion
Time frame: 4 months
To assess the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound.
2 secondary outcomes
Predicting value of diaphragm excursion
Time frame: 4 months
Combination index prediction for weaning
Time frame: 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weaning and Diaphragm Ultrasound, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 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: withdrawn, as of the sponsor's last update on 7 Feb 2024. 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 Spain. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pimax and diaphragm inspiratory excursion (time frame: 4 months). 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 7 Feb 2024.