Continuous Evaluation of Diaphragm Function

Not Applicable

• Conditions: Critical Illness; Respiration, Artificial; Mechanical Ventilation
• Interventions: Diagnostic Test: Assesment of diaphragm function

• Registration Number: NCT03941002
• Lead Sponsor: University of Milan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Study Start: 2019-09-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-05
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Reduced pressure support	Assesment of diaphragm function	The level of inspiratory pressure support will be reduced by 25%
Lowest pressure support	Assesment of diaphragm function	The level of inspiratory pressure support will be reduced by 50%
Clinical pressure support	Assesment of diaphragm function	The level of inspiratory pressure support will be selected by the attending physician

Primary Outcome Measures

Name	Time	Method
Diaprhagm excursion	Study 1 day	Excursion (in mm) between expiration and inspiration

Secondary Outcome Measures

Name	Time	Method
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 trasndiaphragmatic pressure over time (in cmH2O\*sec)

Trial Locations

Locations (1)

Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo; 🇮🇹 Milano, MI, Italy