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Completed

NCT Number: NCT04519450

Ultrasound of Accessory Respiratory Muscles

The aim of this study is to compare the diameter of accessory respiratory muscles in patients with respiratory diseases and patients without such diseases, and to determine whether there is a connection between the ultrasound-measured thickness of accessory respiratory muscles and time of mechanical ventilation, as well as whether there is a the connection between the measured thickness and the treatment outcome of patients in the Intensive Care Unit (ICU).

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Key information

Conditions

Mechanical Ventilation Duration of Treatment Survival

Sex eligibility

All sexes

Study type

Observational

Primary location

Osijek University Hospital

Osijek, 31000, Croatia

About this study

An informed consent for the study was obtained from Ethics Committee, Osijek University Hospital, and Medical Faculty. Each patient will sign an informed consent prior to the inclusion into the prospective observational study.

In all patients, the thickness of the sternocleidomastoid muscle (SCM), trapezius muscle (TM), and quadriceps femoris (QF) muscle will be measured. A measurement point is in the middle of each muscle. The diameter of each muscle will be measured three times, and the average of the three measurements will be calculated.

In each patient hours of mechanical ventilation, and total time in the ICU will be recorded. Patients' comorbidities, ie. hypertension, cardiac diseases, diabetes, and other metabolic disorders, history of stroke, disabilities, as well as procedures done will be registered.

A Pearson's or Spearman's correlation will be used to calculate connections between specific parameters.

Who can participate

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

Inclusion criteria

  • Patients with and without chronic respiratory diseases
  • Mechanically ventilated patients
  • Patients who gave consent to participate in the study

Exclusion criteria

  • Patients with severe head and neck trauma
  • Patients who have had upper leg surgery
  • Patients who did not consent to participate in the study

Treatment and study plan

Mindray TE7 ultrasound machine

Device

The study was performed using a Mindray TE7 ultrasound machine with the depth of the linear probe at 70 mm and gain of 90 dB; settings remained unchanged during the study. Measurements of the right m. sternocleidomastoideus, the right m. trapezius, and the right upper leg were taken, with the final value being the average of three measurements for each. The probe was set at the musculoskeletal ultrasound setting.

Other names: Mindray TE7

Primary outcomes

  1. Number of days in the ICU

    Time frame: Three months

    In order to be able to determine the outcome of treatment of patients in the intensive care unit, it is necessary to have a variable on how long the patients have been in the intensive care unit. Days spent in the ICU until discharge or death will be recorded.

  2. Hours of mechanical ventilation

    Time frame: Three months

    Total hours spent on the mechanical ventilation is an important variable to compare with the treatment outcome of patients in the intensive care unit.

    Hours on mechanical ventilation until extubation will be recorded.

  3. Accessory respiratory musculature thickness in patients with chronic lung disease and without chronic lung disease will be compared.

    Time frame: Three months

    An average of three measurements of accessory respiratory muscles, i.e. sternocleidomastoid (SCM) and trapezius muscle (TM) will be recorded.

    In addition, four heads of quadriceps femoris (QF) muscle will be measured three times and average of measurements will be recorded. A sum of all four heads will be registered in every patient. QF is usually a measure of patients' nutritive status and his/her mobility. It is expected to be thinner in the malnourished patients, in patients with mobility disorders and in older patients.

    A ratio between SCM, TM, and QF will be calculated for all the patients.

  4. Relationship between quadriceps muscle (QM) thickness and patient age

    Time frame: Three months

    A correlation between patients' age and QM will be calculated.

  5. Outcomes of the patients' treatment in the intensive care unit, will be recorded and correlated with QF, accessory respiratory muscles (SCM and TM) thicknes.

    Time frame: Three months

    A ratio between SCM and TM will be correlated with duration of the mechanical ventilation and total days in the ICU.

Secondary outcomes

  1. An influence of patients' demographic characteristics will be recorded and correlated with muscle thickness and outcomes.

    Time frame: Three months

    For each patient age, sex, BMI, and comorbidities will be recorded, and correlated with hours of mechanical ventilation, days of ICU stay, and with accessory respiratory muscle thickness. A Pearson's or Spearman's correlation will be used for corelation analysis.

Sponsors and collaborators

Lead sponsor

Osijek University Hospital

Other

Registry information

Official study title

Ultrasound Measurements of Accessory Respiratory Muscles in the Intensive Care Unit

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Aug 19, 2020
Registry last updated
Feb 23, 2021

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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