Skip to content

Evaluation of Peripheral Muscle With Ultrassonografic of Critical Patients With Covid-19

Evaluation of Peripheral Muscle With Ultrassonografic of Critical Patients With Covid-19

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05055440
Enrollment
30
Registered
2021-09-24
Start date
2021-12-20
Completion date
2022-06-30
Last updated
2022-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 Respiratory Infection

Keywords

SARS-CoV-2, Intensive care unit, Coronavirus, Peripheral muscle, Atrophy muscular, Uultrasound evaluation, Critically ill

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.

Interventions

None listed

Sponsors

Universidade Federal de Pernambuco
CollaboratorOTHER
University of Pernambuco
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Peripheral muscle thickess measured during ultrasonography25 minutesPeripheral muscle thickess expressed in centimeters
Cross-sectional area measured during ultrasonography10 minutesCross-sectional area thickening expressed in square centimeters

Secondary

MeasureTime frameDescription
ICU MortalityThrough study completion, an average of 1 weekTo quantify number of living days between ICU admission and deceased status
Murray Score (LIS)1 hoursScoring system for lung injury including hypoxemia, respiratory system compliance, chest radiographic findings and level of PEEP. The minimum value is zero and the maximum value is sixteen. The higher the score the worse outcome.
Acute Physiologic and Chronic Health Evaluation II - APACHE II10 minutesScoring system to objectively quantify disease severity and predict hospital mortality risk.
Simplified Acute Physiological Score (SAPS3)10 minutesScoring system applied aims to analyze the severity of the disease during the ICU stay, consisting of previous data on the health status, complications that led to hospitalization, information related to the physiological and laboratory tests during the ICU stay
Duration of mechanical ventilation (MV days)Through study completion, an average of 1 weekTo quantity the number of days with use of invasive mechanical ventilation in inpatients.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026