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Clinical Trials/NCT03941002
NCT03941002
Unknown
N/A

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

University of Milan1 site in 1 country25 target enrollmentSeptember 30, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Respiration, Artificial
Sponsor
University of Milan
Enrollment
25
Locations
1
Primary Endpoint
Diaprhagm excursion
Last Updated
5 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
September 30, 2019
End Date
June 30, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Davide Chiumello

Director of Intensive Care

University of Milan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Diaprhagm excursion

Time Frame: Study 1 day

Excursion (in mm) between expiration and inspiration

Secondary Outcomes

  • Esophageal pressure swing(Study 1 day)
  • Pressure-time product(Study 1 day)

Study Sites (1)

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