Continuous Evaluation of Diaphragm Function

Critical Illness Clinical Trial

Official title:

Continuous Evaluation of Diaphragm Function During Assisted Mechanical Ventilation in Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941002
• Other study ID #: WOB-DiaMon
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: November 2020
• Source: University of Milan
• Contact: Davide Chiumello
• Phone: +390281844476
• Email: davide.chiumello[@]unimi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Mechanical Ventilation
• Respiration, Artificial

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Italy	Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaprhagm excursion	Excursion (in mm) between expiration and inspiration	Study 1 day
Secondary	Esophageal pressure swing	Difference (in cmH2O) in esophageal pressure between expiration and inspiration	Study 1 day
Secondary	Pressure-time product	Integral of the area under the esophageal pressure over time (in cmH2O*sec)	Study 1 day
Secondary	Pressure-time product	Integral of the area under the trasndiaphragmatic pressure over time (in cmH2O*sec)	Study 1 day