Ultrasound of Accessory Respiratory Muscles

Completed

• Conditions: Mechanical Ventilation; Duration of Treatment; Survival
• Interventions: Device: Mindray TE7 ultrasound machine

• Registration Number: NCT04519450
• Lead Sponsor: Osijek University Hospital

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2020-03-03
• Status Verified: 2020-08
• Study First Submitted: 2020-08-17
• Study First Submitted QC: 2020-08-17
• Study First Posted: 2020-08-19
• Primary Completion: 2020-10-30
• Study Completion: 2020-12-01
• Last Update Submitted: 2021-02-22
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU patients without an with chronic respiratory diseases	Mindray TE7 ultrasound machine	The group will consist of \>50 patients admitted to the intensive care unit, of which at least 20 with chronic respiratory diseases. Patients of both sexes, patients with and without chronic respiratory diseases, and also patients requiring mechanical ventilation were included and their demographic characteristics and outcomes registered. All patients will sign an informed consent form before inclusion in the prospective observational study.

Primary Outcome Measures

Name	Time	Method
Number of days in the ICU	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.	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	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.	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Osijek University Hospital; 🇭🇷 Osijek, Croatia