Clinical trial NCT05055440: Evaluation of Peripheral Muscle With Ultrassonografic of Critical Patients With Covid-19
Official title: Evaluation of Peripheral Muscle With Ultrassonografic of Critical Patients With Covid-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Respiratory Infection
Keywords: SARS-CoV-2
Intensive care unit
Coronavirus
Peripheral muscle
Atrophy muscular
Uultrasound evaluation
Critically ill
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Pernambuco
First posted: 2021-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The sample consisted of volunteers with COVID - 19 admitted to the SRAG ICU on mechanical ventilation due to acute respiratory failure.

Brief summary: Currently, the tools available for assessing peripheral muscle dysfunction in the intensive care setting require patient collaboration. Several studies have shown that peripheral muscle ultrasound is capable of reliably detecting morphological changes in critically ill patients, in addition to contributing to the identification of patients at higher risk of prolonged complications, especially when performed daily. In this sense, a valid, non-volitional alternative capable of determining muscle mass is through ultrasound assessment. However, current studies are characterized by a lack of standardization in their protocols, which include proper positioning of limbs, transducer, clear reference points and techniques for better visualization of the assessed muscle, in addition to significant methodological defects and inadequate sample sizes. We believe that, together with a tool capable of determining muscle mass and being a safe and non-invasive method, we can contribute to a more complete assessment of these patients, exploring outcomes such as survival, length of stay in the ICU, extubation success and functional capacity. In addition to having the potential to serve as a biomarker of muscle strength during rehabilitation, given little knowledge about the long-term physical consequences of COVID-19, thus promoting a more complete assessment, exploring morphological characteristics of the peripheral muscles resulting from the hospitalization process. and assisting the physiotherapist in clinical decision making in rehabilitation.

Detailed description: Introduction: the length of hospital stay may be associated with factors such as the need for mechanical ventilation, severity of the underlying disease, infections, use of sedation and neuromuscular blockers. In this context, the new coronavirus (SARS-CoV-2) presents itself as a group of viruses that can cause acute respiratory syndromes with mild and severe symptoms, contributing to increased hospital stays and periods of immobility. Peripheral muscle measurement through ultrasound is a topic of growing interest in the assessment of critically ill patients. Currently, this tool has been shown to be able to assess muscle dimensions and morphology during hospitalization in the intensive care unit (ICU) and can be performed at the bedside, presenting itself as a reliable inter and intraobserver method. As this tool does not depend on patient collaboration and is a non-invasive method available in most ICUs, it can provide additional information to the physical examination and clinical impression.

Objective: to evaluate the evolution of ultrasound pattern measurements in mechanically ventilated patients admitted to the ICU.

Methods: prospective cohort study that will be carried out in the ICU of the Recife Women's Hospital, located in Recife - PE, with individuals of both genders, over 18 years old, under mechanical ventilation due to suspicion or confirmation of COVID- 19. To carry out this study, the measurement of the ultrasound pattern of peripheral muscles will be performed from admission to the ICU, with follow-up on the 3rd, 5th and 7th days under mechanical ventilation. The length of stay in the ICU and mechanical ventilation, mortality in this population will also be evaluated. Clinical, laboratory, oxygenation, ventilation, respiratory system mechanics data will also be analyzed. Data will be collected and archived for analysis, which considers differences between groups with p\<0.05. All ethical principles will be respected with either written Free and Consent Term by the patient or relatives at the intensive care phase or at the post ICU discharge phase.

Expected results: to contribute to a more complete assessment of these patients, exploring outcomes such as survival, length of stay in the ICU and effects of immobility on peripheral muscle mass.

Eligibility criteria: Inclusion Criteria:

* Individuals of both genders;
* Age group over 18 years old;
* Individuals who had a confirmed diagnosis for COVID-19 considering their positivity through the RT-PCR exam on mechanical ventilation due to acute respiratory failure

Exclusion Criteria:

- Patients with neurological impairment or known myopathies

Primary outcomes:
measure: Peripheral muscle thickess measured during ultrasonography
timeFrame: 25 minutes
measure: Cross-sectional area measured during ultrasonography
timeFrame: 10 minutes
Secondary outcomes:
measure: Murray Score (LIS)
timeFrame: 1 hours
measure: Duration of mechanical ventilation (MV days)
timeFrame: Through study completion, an average of 1 week
measure: ICU Mortality
timeFrame: Through study completion, an average of 1 week
measure: Simplified Acute Physiological Score (SAPS3)
timeFrame: 10 minutes
measure: Acute Physiologic and Chronic Health Evaluation II - APACHE II
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Physical Therapy Department, Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Pedro Henrique de Moura
role: PRINCIPAL_INVESTIGATOR
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