Continuous Evaluation of Diaphragm Function

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.

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.

Study Overview

• Status: Unknown
• Conditions: Critical Illness; Respiration, Artificial; Mechanical Ventilation
• Intervention / Treatment: Diagnostic test: Assesment of diaphragm function

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • MI
    • Milano, MI, Italy, 20142
      • Recruiting
      • Ospedale San Paolo - Polo Universitario, ASST Santi Paolo e Carlo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Clinical pressure support; The level of inspiratory pressure support will be selected by the attending physician	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
Active Comparator: Reduced pressure support; The level of inspiratory pressure support will be reduced by 25%	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
Active Comparator: Lowest pressure support; The level of inspiratory pressure support will be reduced by 50%	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaprhagm excursion	Excursion (in mm) between expiration and inspiration	Study 1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Esophageal pressure swing	Difference (in cmH2O) in esophageal pressure between expiration and inspiration	Study 1 day
Pressure-time product	Integral of the area under the esophageal pressure over time (in cmH2O*sec)	Study 1 day
Pressure-time product	Integral of the area under the trasndiaphragmatic pressure over time (in cmH2O*sec)	Study 1 day

Collaborators and Investigators

• Sponsor: University of Milan

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2019
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: WOB-DiaMon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No