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NCT Number: NCT05055440

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

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.

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Key information

Conditions

COVID-19 Respiratory Infection Atrophy Coronaviridae Infections Coronavirus Infections Critical Illness Disease Attributes Infections Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nidovirales Infections Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms RNA Virus Infections Signs and Symptoms Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Physical Therapy Department, Universidade Federal de Pernambuco

Recife, Pernambuco, 50670-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Peripheral muscle thickess measured during ultrasonography

    Time frame: 25 minutes

    Peripheral muscle thickess expressed in centimeters

  2. Cross-sectional area measured during ultrasonography

    Time frame: 10 minutes

    Cross-sectional area thickening expressed in square centimeters

Secondary outcomes

  1. Murray Score (LIS)

    Time frame: 1 hours

    Scoring 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.

  2. Duration of mechanical ventilation (MV days)

    Time frame: Through study completion, an average of 1 week

    To quantity the number of days with use of invasive mechanical ventilation in inpatients.

  3. ICU Mortality

    Time frame: Through study completion, an average of 1 week

    To quantify number of living days between ICU admission and deceased status

  4. Simplified Acute Physiological Score (SAPS3)

    Time frame: 10 minutes

    Scoring 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

  5. Acute Physiologic and Chronic Health Evaluation II - APACHE II

    Time frame: 10 minutes

    Scoring system to objectively quantify disease severity and predict hospital mortality risk.

Sponsors and collaborators

Lead sponsor

University of Pernambuco

Other

Collaborators

  • Universidade Federal de Pernambuco

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2021
Registry last updated
Aug 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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