Mechanical VentilationNCT04519450
Ultrasound of Accessory Respiratory Muscles
An observational study of Mechanical Ventilation and Duration of Treatment, run by Osijek University Hospital at 1 site in Croatia.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mechanical Ventilation, Duration of Treatment, Survival
- What is being tested?
- Mindray TE7 ultrasound machine
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteCroatia
- Study dates
- 3 Mar 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with and without chronic respiratory diseases
- Mechanically ventilated patients
- Patients who gave consent to participate in the study
Who cannot join
- Patients with severe head and neck trauma
- Patients who have had upper leg surgery
- Patients who did not consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Measurements of Accessory Respiratory Muscles in the Intensive Care Unit
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).
Read the 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.
- Conditions
- Mechanical Ventilation, Duration of Treatment, Survival
- Being tested
- Mindray TE7 ultrasound machine
- Keywords
- Respiratory Muscles, Critical Care, Ultrasonography, Critical Care Outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindray TE7 ultrasound machineDevice
Also called Mindray TE7
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mindray TE7 ultrasound machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
Relationship between quadriceps muscle (QM) thickness and patient age
A correlation between patients' age and QM will be calculated.
Measured: Three months
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.
Measured: Three months
Secondary outcomes (1)
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start3 Mar 2020
- Primary completion30 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osijek University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lea Atlagic, M.D., Principal investigator, Osijek University Hospital; Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519450
- Sponsor's protocol ID
- OsijekUH-8
- Status last verified
- Aug 2020
- First submitted
- 17 Aug 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the study is completed the data will be publicly available.
Publications
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.
PubMed 30591032Zhi 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.
PubMed 32527360Weijs 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.
PubMed 24410863Gruther 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.
PubMed 18292919Nijholt 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.
PubMed 30904216
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Measurements of Accessory Respiratory Muscles in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04519450
- Acronym / sponsor ID
- OsijekUH-8
- Conditions
- Mechanical Ventilation, Duration of Treatment, Survival
- Keywords
- Respiratory Muscles, Critical Care, Ultrasonography, Critical Care Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Osijek University HospitalUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 30 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients without an with chronic respiratory diseases | – | Device: Mindray TE7 ultrasound machineThe 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. |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with and without chronic respiratory diseases
- Mechanically ventilated patients
- Patients who gave consent to participate in the study
Key exclusion criteria (3 listed)
- Patients with severe head and neck trauma
- Patients who have had upper leg surgery
- Patients who did not consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindray TE7 ultrasound machineAlso: Mindray TE7The 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. | Device | ICU patients without an with chronic respiratory diseases |
Primary outcome
Number of days in the ICU
Time frame: 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.
Hours of mechanical ventilation
Time frame: 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.
Accessory respiratory musculature thickness in patients with chronic lung disease and without chronic lung disease will be compared.
Time frame: 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.
Relationship between quadriceps muscle (QM) thickness and patient age
Time frame: Three months
A correlation between patients' age and QM will be calculated.
Outcomes of the patients' treatment in the intensive care unit, will be recorded and correlated with QF, accessory respiratory muscles (SCM and TM) thicknes.
Time frame: Three months
A ratio between SCM and TM will be correlated with duration of the mechanical ventilation and total days in the ICU.
1 secondary outcome
An influence of patients' demographic characteristics will be recorded and correlated with muscle thickness and outcomes.
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Background: PubMed 30591032Pardo 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.
- Background: PubMed 32527360Zhi 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.
- Background: PubMed 24410863Weijs 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.
- Background: PubMed 18292919Gruther 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.
- Background: PubMed 30904216Nijholt 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.
- Individual participant dataSharing planned: Yes. Once the study is completed the data will be publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lea Atlagic, M.D. principal investigator
Osijek University Hospital; Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Duration of Treatment, run by Osijek University Hospital at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days in the ICU (time frame: Three months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04519450, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.