Clinical trial NCT04519450: Ultrasound of Accessory Respiratory Muscles
Official title: Ultrasound Measurements of Accessory Respiratory Muscles in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation
Duration of Treatment
Survival
Keywords: Respiratory Muscles
Critical Care
Ultrasonography
Critical Care Outcomes
Lead sponsor: Osijek University Hospital
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study was conducted on 50 patients admitted into the ICU. Patients of both genders were included, with and without chronic respiratory diseases, including mechanically ventilated patients.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of days in the ICU
timeFrame: Three months
measure: Hours of mechanical ventilation
timeFrame: Three months
measure: Accessory respiratory musculature thickness in patients with chronic lung disease and without chronic lung disease will be compared.
timeFrame: Three months
measure: Relationship between quadriceps muscle (QM) thickness and patient age
timeFrame: Three months
measure: Outcomes of the patients' treatment in the intensive care unit, will be recorded and correlated with QF, accessory respiratory muscles (SCM and TM) thicknes.
timeFrame: Three months
Secondary outcomes:
measure: An influence of patients' demographic characteristics will be recorded and correlated with muscle thickness and outcomes.
timeFrame: Three months
Other outcomes:
Locations:
city: Osijek
country: Croatia
facility: Osijek University Hospital
Study officials:
affiliation: Osijek University Hospital; Medical Faculty
name: Lea Atlagic, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.