Mechanical Ventilation Clinical Trial
Official title:
Ultrasound Measurements of Accessory Respiratory Muscles in the Intensive Care Unit
NCT number | NCT04519450 |
Other study ID # | OsijekUH-8 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 3, 2020 |
Est. completion date | December 1, 2020 |
Verified date | August 2020 |
Source | Osijek University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 60 |
Est. completion date | December 1, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | |
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 |
Country | Name | City | State |
---|---|---|---|
Croatia | Osijek University Hospital | Osijek |
Lead Sponsor | Collaborator |
---|---|
Osijek University Hospital |
Croatia,
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
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 |
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