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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05019313
Enrollment
38
Registered
2021-08-24
Start date
2020-04-01
Completion date
2022-03-31
Last updated
2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Pneumonia, Diaphragm Disease

Keywords

diaphragm thickening fraction, happy hypoxemia, diaphragmatic ultrasound evaluation, SARS-CoV-2 pneumonia

Brief summary

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.

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.

Interventions

DEVICEEvaluation 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.

Sponsors

Azienda Sanitaria-Universitaria Integrata di Udine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diaphragmatic function evaluation by measuring right diaphragmatic thickening fractionDuring weaning by mechanical ventilation before attempt of extubationRight 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. .

Secondary

MeasureTime frameDescription
Weaning attempt success/failure frequency with consequent need of tracheostomy or endotracheal re-intubation.After weaning and eventually extubationAfter 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

Other

MeasureTime frameDescription
Duration of mechanical ventilation.from intubation to the end of mechanical ventilation supporthours record/assessment of mechanical ventilation after intubation
ICU and Hospital length of stay and mortality.from first day of hospitalization (admission to the hospital) to the last day (discharge from the hospital), an average of 90 daysnumber of days in ICU and hospital stay

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026