Clinical trial NCT05019313: Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in the Positive COVID-19 Patient
Official title: Diaphragm Ultrasound Evaluation During Weaning From Mechanical Ventilation in the Positive COVID-19 Patient
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pneumonia
Diaphragm Disease
Keywords: diaphragm thickening fraction
happy hypoxemia
diaphragmatic ultrasound evaluation
SARS-CoV-2 pneumonia
Lead sponsor: Azienda Sanitaria-Universitaria Integrata di Udine
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diaphragmatic function evaluation by measuring right diaphragmatic thickening fraction
timeFrame: During weaning by mechanical ventilation before attempt of extubation
Secondary outcomes:
measure: Weaning attempt success/failure frequency with consequent need of tracheostomy or endotracheal re-intubation.
timeFrame: After weaning and eventually extubation
Other outcomes:
measure: Duration of mechanical ventilation.
timeFrame: from intubation to the end of mechanical ventilation support
measure: ICU and Hospital length of stay and mortality.
timeFrame: from first day of hospitalization (admission to the hospital) to the last day (discharge from the hospital), an average of 90 days
Locations:
city: Udine
country: Italy
facility: Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD
Study officials:
References:
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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.
citation: 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.