Ultrasound of Accessory Respiratory Muscles

NCT ID: NCT04519450

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-03

Study Completion Date

2020-12-01

Brief Summary

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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

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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.

Conditions

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Mechanical Ventilation Duration of Treatment Survival

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ICU patients without an with chronic respiratory diseases

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.

Mindray TE7 ultrasound machine

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Mindray TE7

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osijek University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lea Atlagic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Osijek University Hospital; Medical Faculty

Locations

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Osijek University Hospital

Osijek, , Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type BACKGROUND
PMID: 30591032 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32527360 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24410863 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18292919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30904216 (View on PubMed)

Other Identifiers

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OsijekUH-8

Identifier Type: -

Identifier Source: org_study_id

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