Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in the Positive COVID-19 Patient

August 22, 2021 updated by: Luigi Vetrugno, Azienda Sanitaria-Universitaria Integrata di Udine

Hypoxemic acute respiratory failure is one of the main COVID-19 patients complication that lead to in intensive care hospitalization.

This complication determines a variable mortality from 25 to 30%. To correct hypoxemia (often severe) is often needed non-invasive or invasive mechanical ventilation.

Mechanical ventilation is not a therapeutic strategy, but it allows to extend the time-to-recovery necessary to solve COVID-19 respiratory failure cause.

Calibration of ventilatory support is essential to ensure adequate time-to-recovery without contributing to onset lung and / or diaphragmatic damage.

Basal diaphragmatic activity assessment, device for administering the oxygenation support choice and setting ventilatory support parameters are decisive.

Ultrasound is the best method for measuring diaphragmatic work. The aim of this study is to evaluate the diaphragmatic thickening fraction in COVID-19 patients admitted to Intensive Care Unit (ICU) for acute respiratory failure and to record its function on weaning.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Hypoxemic acute respiratory failure in COVID-19 patients often leads to necessity of intubation and mechanical ventilation support. Complications may be severe as Ventilator-Induced Lung Injury (VILI) and respiratory infections. Weaning process from mechanical ventilation is based on respiratory work reduction and mechanical support to allow patient's respiratory ability to recovery. Respiratory muscle strength give an important contribute. Ultrasound diaphragmatic evaluation is essential to evaluate patients respiratory capacity as diaphragm atrophy usually suggest a difficult process and weaning failure.

COVID-19 pneumonia represent a particular type of ARDS (acute respiratory distress syndrome), in which different mechanism such as interstitial edema and diffuse alveolar damage, ventilation-perfusion mismatch, intrapulmonary shunt play a role/attend The aim of this study is to assess diaphragmatic function in weaning from mechanical ventilation in patients affected from COVID-19 respiratory failure and his implications.

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Udine, Italy, 33100
        • Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with severe hypoxemic covid-related respiratory failure admitted to intensive care unit in Udine and five other centers. These subjects required mechanical ventilation during hospitalization.

Description

Inclusion Criteria:

  • Hypoxemic respiratory failure in COVID-19 patients during intensive care unit hospitalization
  • Age> 18 years
  • Weaning by mechanical ventilation

Exclusion Criteria:

  • tracheostomy,
  • unstable clinical conditions;
  • agitation (Richmond Agitation-Sedation Scale (RASS)≥ + 2) or non-cooperation (Kelly Matthay scale ≥5);
  • more than two organ failure
  • consent refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COVID 19 positive patients

COVID19 positive patients with hypoxemic acute respiratory failure hospitalized in intensive care unit.

This study evaluates diaphragmatic contractility with ultrasound, blood gas analytical parameters during weaning from invasive mechanical ventilation
Device: Evaluation of diaphragmatic contractility by ultrasound
Lung ultrasound is performed during mechanical ventilation weaning. The diaphragmatic thickening fraction is evaluated positioning a linear probe in midaxillary line. Inspiratory and expiratory measurements are bilateral and are M-mode images. Right diaphragmatic thickening fraction has been considered as true and reproducible measurement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragmatic function evaluation by measuring right diaphragmatic thickening fraction
Time Frame: During weaning by mechanical ventilation before attempt of extubation
Right diaphragmatic thickening fraction is evaluated by positioning a linear ultrasound probe at the level of the midaxillary line (pointer oriented towards the axillary cavity). Patient is in the supine position. Inspiratory and expiratory measurements are made as M-mode images. Right diaphragmatic measurement is considered as a reference. .
During weaning by mechanical ventilation before attempt of extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weaning attempt success/failure frequency with consequent need of tracheostomy or endotracheal re-intubation.
Time Frame: After weaning and eventually extubation
After extubation it is considered as weaning attempt success a 48 hours time free need of non invasive (not prophylatic) or invasive ventilation with re-intubation and/or tracheostomy
After weaning and eventually extubation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation.
Time Frame: from intubation to the end of mechanical ventilation support
hours record/assessment of mechanical ventilation after intubation
from intubation to the end of mechanical ventilation support
ICU and Hospital length of stay and mortality.
Time Frame: from first day of hospitalization (admission to the hospital) to the last day (discharge from the hospital), an average of 90 days
number of days in ICU and hospital stay
from first day of hospitalization (admission to the hospital) to the last day (discharge from the hospital), an average of 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Sanitaria-Universitaria Integrata di Udine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

August 2, 2021

First Submitted That Met QC Criteria

August 22, 2021

First Posted (Actual)

August 24, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 22, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-DIAUS 1.2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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