Critical Illness, Mechanical Ventilation, Respiration, Artificial
Conditions
Brief 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 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: 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.
Interventions
DIAGNOSTIC_TESTAssesment 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
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) * Pregnancy * Circulatory failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diaprhagm excursion | Study 1 day | Excursion (in mm) between expiration and inspiration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Esophageal pressure swing | Study 1 day | Difference (in cmH2O) in esophageal pressure between expiration and inspiration |
| Pressure-time product | Study 1 day | Integral of the area under the esophageal pressure over time (in cmH2O\*sec) |
Countries
Italy
Contacts
Primary ContactDavide Chiumello
Outcome results
None listed