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

NCT05019313 | Unknown

• 1 other identifier: COVID-DIAUS 1.2
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Pneumonia; Diaphragm Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  After weaning and eventually extubation

Other Outcomes (2)

• Duration of mechanical ventilation.

  from intubation to the end of mechanical ventilation support

• 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 days

Study Arms (1)

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

Interventions

Evaluation of diaphragmatic contractility by ultrasound DEVICE

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.

COVID 19 positive patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (1)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, 33100, Italy

Location

Related Publications (6)

• 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.

  PMID: 32250385 BACKGROUND

• Azoulay E, Thiery 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.

  PMID: 15525848 BACKGROUND

• Thiery G, Azoulay E, Darmon M, Ciroldi M, De Miranda S, Levy 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. doi: 10.1200/JCO.2005.01.487.

  PMID: 15994150 BACKGROUND

• 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. No abstract available.

  PMID: 32291463 BACKGROUND

• 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.

  PMID: 32239532 BACKGROUND

• Vetrugno L, Orso D, Corradi F, Zani G, Spadaro S, Meroi F, D'Andrea N, Bove T, Cammarota G, De Robertis E, Ferrari S, Guarnieri M, Ajuti M, Fusari M, Grieco DL, Deana C, Boero E, Franchi F, Scolletta S, Maggiore SM, Forfori F. Diaphragm ultrasound evaluation during weaning from mechanical ventilation in COVID-19 patients: a pragmatic, cross-section, multicenter study. Respir Res. 2022 Aug 21;23(1):210. doi: 10.1186/s12931-022-02138-y.

  PMID: 35989352 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 24, 2021
• Study Start: April 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: March 31, 2022
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

IT (1)