COVID-19 Pneumonia Clinical Trial
Official title:
Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in the Positive COVID-19 Patient
Verified date | August 2021 |
Source | Azienda Sanitaria-Universitaria Integrata di Udine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 38 |
Est. completion date | March 31, 2022 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD | Udine |
Lead Sponsor | Collaborator |
---|---|
Azienda Sanitaria-Universitaria Integrata di Udine |
Italy,
Azoulay É, Thiéry G, Chevret S, Moreau D, Darmon M, Bergeron A, Yang K, Meignin V, Ciroldi M, Le Gall JR, Tazi A, Schlemmer B. The prognosis of acute respiratory failure in critically ill cancer patients. Medicine (Baltimore). 2004 Nov;83(6):360-370. doi: 10.1097/01.md.0000145370.63676.fb. — View Citation
Gattinoni L, Chiumello D, Caironi P, Busana M, Romitti F, Brazzi L, Camporota L. COVID-19 pneumonia: different respiratory treatments for different phenotypes? Intensive Care Med. 2020 Jun;46(6):1099-1102. doi: 10.1007/s00134-020-06033-2. Epub 2020 Apr 14. — View Citation
Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394. Erratum in: JAMA. 2021 May 25;325(20):2120. — View Citation
Thiéry G, Azoulay E, Darmon M, Ciroldi M, De Miranda S, Lévy V, Fieux F, Moreau D, Le Gall JR, Schlemmer B. Outcome of cancer patients considered for intensive care unit admission: a hospital-wide prospective study. J Clin Oncol. 2005 Jul 1;23(19):4406-13. — View Citation
Vetrugno L, Bove T, Orso D, Barbariol F, Bassi F, Boero E, Ferrari G, Kong R. Our Italian experience using lung ultrasound for identification, grading and serial follow-up of severity of lung involvement for management of patients with COVID-19. Echocardiography. 2020 Apr;37(4):625-627. doi: 10.1111/echo.14664. Epub 2020 Apr 15. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Duration of mechanical ventilation. | hours record/assessment of mechanical ventilation after intubation | from intubation to the end of mechanical ventilation support | |
Other | ICU and Hospital length of stay and mortality. | 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 | |
Primary | Diaphragmatic function evaluation by measuring right diaphragmatic thickening fraction | 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 | Weaning attempt success/failure frequency with consequent need of tracheostomy or endotracheal re-intubation. | 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 |
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