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临床试验/NCT04519450
NCT04519450已完成不适用

Ultrasound Measurements of Accessory Respiratory Muscles in the Intensive Care Unit

Osijek University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年3月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Number of days in the ICU

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Number of days in the ICU

时间窗: 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.

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

时间窗: Three months

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

Relationship between quadriceps muscle (QM) thickness and patient age

时间窗: Three months

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

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

时间窗: 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.

Hours of mechanical ventilation

时间窗: 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.

次要结局

  • An influence of patients' demographic characteristics will be recorded and correlated with muscle thickness and outcomes.(Three months)

研究者

发起方
Osijek University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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