Ultrasound of Accessory Respiratory Muscles

Mechanical Ventilation Clinical Trial

Official title:

Ultrasound Measurements of Accessory Respiratory Muscles in the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04519450
• Other study ID #: OsijekUH-8
• Status: Completed
• Start date: March 3, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: August 2020
• Source: Osijek University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 1, 2020
• Est. primary completion date: October 30, 2020
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Duration of Treatment
• Mechanical Ventilation
• Survival

Intervention

Device:
• Mindray TE7 ultrasound machine
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.

Locations

Country	Name	City	State
Croatia	Osijek University Hospital	Osijek

Sponsors (1)

Lead Sponsor	Collaborator
Osijek University Hospital

Country where clinical trial is conducted

Croatia, 

References & Publications (5)

Gruther W, Benesch T, Zorn C, Paternostro-Sluga T, Quittan M, Fialka-Moser V, Spiss C, Kainberger F, Crevenna R. Muscle wasting in intensive care patients: ultrasound observation of the M. quadriceps femoris muscle layer. J Rehabil Med. 2008 Mar;40(3):185-9. doi: 10.2340/16501977-0139. — View Citation

Nijholt W, Beek LT, Hobbelen JSM, van der Vaart H, Wempe JB, van der Schans CP, Jager-Wittenaar H. The added value of ultrasound muscle measurements in patients with COPD: An exploratory study. Clin Nutr ESPEN. 2019 Apr;30:152-158. doi: 10.1016/j.clnesp.2019.01.001. Epub 2019 Jan 29. — View Citation

Pardo E, El Behi H, Boizeau P, Verdonk F, Alberti C, Lescot T. Reliability of ultrasound measurements of quadriceps muscle thickness in critically ill patients. BMC Anesthesiol. 2018 Dec 27;18(1):205. doi: 10.1186/s12871-018-0647-9. — View Citation

Weijs PJ, Looijaard WG, Dekker IM, Stapel SN, Girbes AR, Oudemans-van Straaten HM, Beishuizen A. Low skeletal muscle area is a risk factor for mortality in mechanically ventilated critically ill patients. Crit Care. 2014 Jan 13;18(2):R12. doi: 10.1186/cc13189. — View Citation

Zhi H, Guo J, Zhao Y, Nie S, Li S, Wang S, Li Y. [Diagnostic accuracy of bedside ultrasound measurement of limb skeletal muscle thickness for intensive care unit-acquired weakness]. Zhonghua Wei Zhong Bing Ji Jiu Yi Xue. 2020 Apr;32(4):494-497. doi: 10.3760/cma.j.cn121430-20200403-00084. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days in the ICU	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.	Three months
Primary	Hours of mechanical ventilation	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.	Three months
Primary	Accessory respiratory musculature thickness in patients with chronic lung disease and without chronic lung disease will be compared.	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.	Three months
Primary	Relationship between quadriceps muscle (QM) thickness and patient age	A correlation between patients' age and QM will be calculated.	Three months
Primary	Outcomes of the patients' treatment in the intensive care unit, will be recorded and correlated with QF, accessory respiratory muscles (SCM and TM) thicknes.	A ratio between SCM and TM will be correlated with duration of the mechanical ventilation and total days in the ICU.	Three months
Secondary	An influence of patients' demographic characteristics will be recorded and correlated with muscle thickness and outcomes.	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.	Three months