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

• Conditions: COVID-19 Pneumonia; Diaphragm Disease
• Interventions: Device: Evaluation of diaphragmatic contractility by ultrasound

• Registration Number: NCT05019313
• Lead Sponsor: Azienda Sanitaria-Universitaria Integrata di Udine

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.

Study Timeline

• Study Start: 2020-04-01
• Primary Completion: 2021-06-30
• Status Verified: 2021-08
• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-08-22
• Last Update Submitted: 2021-08-22
• Study First Posted: 2021-08-24
• Last Update Posted: 2021-08-24
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID 19 positive patients	Evaluation of diaphragmatic contractility by ultrasound	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

Primary Outcome Measures

Name	Time	Method
Diaphragmatic function evaluation by measuring right diaphragmatic thickening fraction	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. .

Secondary Outcome Measures

Name	Time	Method
Weaning attempt success/failure frequency with consequent need of tracheostomy or endotracheal re-intubation.	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

Trial Locations

Locations (1)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD; 🇮🇹 Udine, Italy