Respiration, ArtificialNCT03941002
Continuous Evaluation of Diaphragm Function
A study testing Assesment of diaphragm function in people with Respiration, Artificial and Mechanical Ventilation, run by University of Milan at 1 site in Italy.
Trial summary
Aim of mechanical ventilation is to improve gas exchange and to unload the respiratory muscles delivering a form of mechanical support to the ventilation. At the same time, it is essential that the support is individually-tailored to avoid the development of muscular atrophy, a process called "ventilatory-induced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial, Mechanical Ventilation, Critical Illness
- What is being tested?
- Assesment of diaphragm function
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2019to 30 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute respiratory failure which necessitated endotracheal intubation and mechanical ventilation, with ventilation in pressure-support mode.
- Positive end-expiratory pressure (PEEP) lower than 10 cmH2O
- Pressure support level between 4 and 10 cmH2O
- Ratio between PaO2 and FiO2 >200 mmHg
- Resolution of the cause of respiratory failure
Who cannot join
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- Pregnancy
- Circulatory failure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo
Milan, MI, 20142
Davide Chiumello, +390281844020, chiumello@libero.it
About this study
Official title: Continuous Evaluation of Diaphragm Function During Assisted Mechanical Ventilation in Critically Ill Patients
Aim of mechanical ventilation is to improve gas exchange and to unload the respiratory muscles delivering a form of mechanical support to the ventilation. At the same time, it is essential that the support is individually-tailored to avoid the development of muscular atrophy, a process called "ventilatory-induced diaphragm dysfunction"
Aim of the present study is that the continuous ultrasonographic assesment of diaphragm function, as obtained by the device under investigation (DiaMon, Respinor AS, Oslo, Norway) is related to the degree of effort of inspiratory muscles, as measured by gold-standard indices such as esophageal and gastric pressure measurement.
Read more
A secondary aim is that the data assessed by the device are related to a standard ultrasonographic examination performed by expert operators.
In particular, we will enroll a population of critically ill patients undergoing mechanical ventilation in assisted mode, and we will perform a decremental pressure support trial, with the following aims:
- to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to standard mechanical indices of respiratory effort such as the pressure-time product (PTP)
- to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to the ultrasonographic assesment of muscle function performed by an expert operator.
- Being tested
- Assesment of diaphragm function
- Medical subject headings
- Respiratory Aspiration, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assesment of diaphragm functionDiagnostic test
Diaphragm function will be assessed by standard mechanical parameters as assessed by esophageal and gastric pressure measurement, as well as by an ultrasonographic examination performed by an expert operator and by the continuous ultrasonographic assessment provided by the device under investigation
| Study group | Role | What they receive |
|---|---|---|
| Clinical pressure support | Placebo comparator | The level of inspiratory pressure support will be selected by the attending physician Receives: Diagnostic Test: Assesment of diaphragm function |
| Reduced pressure support | Active comparator | The level of inspiratory pressure support will be reduced by 25% Receives: Diagnostic Test: Assesment of diaphragm function |
| Lowest pressure support | Active comparator | The level of inspiratory pressure support will be reduced by 50% Receives: Diagnostic Test: Assesment of diaphragm function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaprhagm excursion
Excursion (in mm) between expiration and inspiration
Measured: Study 1 day
Secondary outcomes (3)
Esophageal pressure swing
Difference (in cmH2O) in esophageal pressure between expiration and inspiration
Measured: Study 1 day
Pressure-time product
Integral of the area under the esophageal pressure over time (in cmH2O*sec)
Measured: Study 1 day
Pressure-time product
Integral of the area under the trasndiaphragmatic pressure over time (in cmH2O*sec)
Measured: Study 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start30 Sep 2019
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration, ArtificialStudies 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
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Davide Chiumello, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941002
- Sponsor's protocol ID
- WOB-DiaMon
- Status last verified
- Nov 2020
- First submitted
- 3 May 2019
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Evaluation of Diaphragm Function During Assisted Mechanical Ventilation in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03941002
- Acronym / sponsor ID
- WOB-DiaMon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 7 May 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.
Aim of mechanical ventilation is to improve gas exchange and to unload the respiratory muscles delivering a form of mechanical support to the ventilation. At the same time, it is essential that the support is individually-tailored to avoid the development of muscular atrophy, a process called "ventilatory-induced diaphragm dysfunction"
Aim of the present study is that the continuous ultrasonographic assesment of diaphragm function, as obtained by the device under investigation (DiaMon, Respinor AS, Oslo, Norway) is related to the degree of effort of inspiratory muscles, as measured by gold-standard indices such as esophageal and gastric pressure measurement.
A secondary aim is that the data assessed by the device are related to a standard ultrasonographic examination performed by expert operators.
In particular, we will enroll a population of critically ill patients undergoing mechanical ventilation in assisted mode, and we will perform a decremental pressure support trial, with the following aims:
- to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to standard mechanical indices of respiratory effort such as the pressure-time product (PTP)
- to evaluate the performance of a continuous and automated device for the monitoring of diaphragm contractile activity, as compared to the ultrasonographic assesment of muscle function performed by an expert operator.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical pressure support | Placebo comparator | Diagnostic Test: Assesment of diaphragm functionThe level of inspiratory pressure support will be selected by the attending physician |
| Reduced pressure support | Active comparator | Diagnostic Test: Assesment of diaphragm functionThe level of inspiratory pressure support will be reduced by 25% |
| Lowest pressure support | Active comparator | Diagnostic Test: Assesment of diaphragm functionThe level of inspiratory pressure support will be reduced by 50% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acute respiratory failure which necessitated endotracheal intubation and mechanical ventilation, with ventilation in pressure-support mode.
- Positive end-expiratory pressure (PEEP) lower than 10 cmH2O
- Pressure support level between 4 and 10 cmH2O
- Ratio between PaO2 and FiO2 >200 mmHg
- Resolution of the cause of respiratory failure
Key exclusion criteria (3 listed)
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- Pregnancy
- Circulatory failure
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 |
|---|---|---|
| Assesment of diaphragm functionDiaphragm function will be assessed by standard mechanical parameters as assessed by esophageal and gastric pressure measurement, as well as by an ultrasonographic examination performed by an expert operator and by the continuous ultrasonographic assessment provided by the device under investigation | Diagnostic test | Clinical pressure support, Lowest pressure support, Reduced pressure support |
Primary outcome
Diaprhagm excursion
Time frame: Study 1 day
Excursion (in mm) between expiration and inspiration
3 secondary outcomes
Esophageal pressure swing
Time frame: Study 1 day
Pressure-time product
Time frame: Study 1 day
Pressure-time product
Time frame: Study 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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 Assesment of diaphragm function in people with Respiration, Artificial and Mechanical Ventilation, run by University of Milan 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 5 inclusion and 3 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 5 Nov 2020. 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. Some participants in this study may receive a placebo. 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?
Contact Davide Chiumello (+390281844476, davide.chiumello@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaprhagm excursion (time frame: Study 1 day). 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 5 Nov 2020.