NCT03941002

Continuous Evaluation of Diaphragm Function

Status unknown NA Last updated 5 November 2020

What this trial tests

NA trial testing Assesment of diaphragm function in Respiration, Artificial in 25 participants. Status unknown.

Timeline

30 September 2019

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	University of Milan
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	diagnostic
Enrollment	25
Start date	30 September 2019
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across Italy

Drugs / interventions tested

• Assesment of diaphragm function

Conditions studied

• Respiration, Artificial — all drugs for Respiration, Artificial →
• Mechanical Ventilation — all drugs for Mechanical Ventilation →
• Critical Illness — all drugs for Critical Illness →

Sponsor

University of Milan

Who can join

18 and older, any sex, with Respiration, Artificial or Mechanical Ventilation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.