Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2019-09-30
2021-06-30
Brief Summary
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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:
1. 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)
2. 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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Clinical pressure support
The level of inspiratory pressure support will be selected by the attending physician
Assesment of diaphragm function
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
Reduced pressure support
The level of inspiratory pressure support will be reduced by 25%
Assesment of diaphragm function
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
Lowest pressure support
The level of inspiratory pressure support will be reduced by 50%
Assesment of diaphragm function
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
Interventions
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Assesment of diaphragm function
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Pregnancy
* Circulatory failure
18 Years
ALL
No
Sponsors
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University of Milan
OTHER
Responsible Party
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Davide Chiumello
Director of Intensive Care
Locations
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Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo
Milan, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WOB-DiaMon
Identifier Type: -
Identifier Source: org_study_id