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Ventilation Therapy; ComplicationsNCT03933332

Correlation Between Muscle Thickness and Inflammation With Ventilator Use in Critically Ill Patients

An observational study of Ventilation Therapy; Complications, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Decrease thickness of diaphragm muscle, cross-sectional area of rectus femoris and biceps brachii muscle, and increase in CRP would affect ventilator length of use in critically ill patients in ICU Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ventilation Therapy; Complications
What is being tested?
Diaphragm thickness, Cross-sectional area of rectus femoris muscle and Cross-sectional area of biceps brachii
How many people
52 participants
Where
1 siteIndonesia
Study dates
1 Oct 2018to 12 Mar 2019
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Critically-ill patients admitted to Intensive Care Units of Cipto Mangunkusumo Hospital using ventilator on October 2018 - December 2018

Who may be able to join

  • Patients who had Modified Rankin Score < 4 in 1 month before admitted into ICU

Who cannot join

  • Pregnant women
  • Patients who had intubation more than 24 hours before admitted at ICU Cipto Mangunkusumo Hospital
  • Patients who had a history or prior to thoracic or heart surgery 14 days before admission
  • Patients who had severe peripheral muscle dysfunction
  • Patients who had a history of admission in hospital for more than 2 weeks on the last 3 months
  • Patients who predicted will be using ventilator for less than 4 days
  • Patients who suffered acute respiratory distress syndrome (ARDS) with a ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) less than 200
  • Patients who declined to participate in this study

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Rumah Sakit Cipto Mangunkusumo

    Jakarta Pusat, DKI Jakarta, 10430

Other trials in Indonesia

About this study

Official title: Correlation Between Muscle Thickness and Inflammation With Ventilator Length of Use in Critically Ill Patients: Study on Diaphragm Thickness, Rectus Femoris and Biceps Brachii Cross-sectional Area, and C-reactive Protein Level

Decrease thickness of diaphragm muscle, cross-sectional area of rectus femoris and biceps brachii muscle, and increase in CRP would affect ventilator length of use in critically ill patients in ICU

Being tested
Diaphragm thickness, Cross-sectional area of rectus femoris muscle, Cross-sectional area of biceps brachii, C-Reactive Protein (CRP) Level

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diaphragm thicknessOther

    measured at apposition zone using ultrasonography in mm

  • Cross-sectional area of rectus femoris muscleOther

    measured at lower one-third line between Spina iliaca anterior inferior (SIAI) and upper border femur patella using ultrasonography in cm^2

  • Cross-sectional area of biceps brachiiOther

    measured at biceps brachii muscle using ultrasonography in cm^2

  • C-Reactive Protein (CRP) LevelDiagnostic test

    quantitative CRP using ELISA method in mcg/mL

Study groups in NCT03933332
Study groupRoleWhat they receive
Ventilator length of usemeasured in days
Receives: Other: Diaphragm thickness; Other: Cross-sectional area of rectus femoris muscle; Other: Cross-sectional area of biceps brachii; Diagnostic Test: C-Reactive Protein (CRP) Level

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation between changes in diaphragm thickness with ventilator length of use

    Correlation between changes in diaphragm thickness with ventilator length of use: < 7 days or >7 days

    Measured: 30 days from admission

  2. Correlation between changes in cross-sectional area of rectus femoris muscle with ventilator length of use

    Correlation between changes in cross-sectional area of rectus femoris muscle with ventilator length of use: < 7 days or >7 days

    Measured: 30 days from admission

  3. Correlation between changes in cross-sectional area of biceps brachii muscle with ventilator length of use

    Correlation between changes in cross-sectional area of biceps brachii muscle with ventilator length of use: < 7 days or >7 days

    Measured: 30 days from admission

  4. Correlation between changes in quantitative C-reactive protein (CRP) level with ventilator length of use

    Correlation between changes in quantitative C-reactive protein (CRP) level with ventilator length of use: < 7 days or >7 days

    Measured: 30 days from admission

Secondary outcomes (5)

  1. Ventilator length of use

    duration of first ventilator use until patient is extubated or deceased: <7 days or >7 days

    Measured: 30 days from admission

  2. Changes in diaphragm thickness

    Measurement of diaphragm thickness from day 1 admission to ICU using ventilator to day 5 in mm

    Score for changes in diaphragm thickness:

    0 : no changes

    1. : decrease thickness of <20%
    2. : decrease thickness of >20%

    Measured: 5 days from admission

  3. Changes in cross-sectional area of rectus femoris muscle

    Measurement of cross-sectional area of rectus femoris muscle from day 1 admission to ICU using ventilator to day 5 in cm^2

    Score for changes in diaphragm thickness:

    0 : no changes

    1. : decrease cross-sectional area of <20%
    2. : decrease cross-sectional area of >20%

    Measured: 5 days from admission

  4. Changes in cross-sectional area of biceps brachii muscle

    Measurement of cross-sectional area of biceps brachii muscle from day 1 admission to ICU using ventilator to day 5 in cm^2

    Score for changes in diaphragm thickness:

    0 : no changes

    1. : decrease cross-sectional area of <20%
    2. : decrease cross-sectional area of >20%

    Measured: 5 days from admission

  5. Changes in quantitative C-reactive protein (CRP) levels

    Measurement of quantitative CRP from day 1 admission to ICU using ventilator to day 5 in mcg/mL

    Score for changes in diaphragm thickness:

    0 : no changes

    1. : increase in quantitative CRP <50%
    2. : increase in quantitative CRP >50%

    Measured: 5 days from admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2019
  2. Study start1 Oct 2018
  3. Primary completion31 Jan 2019
  4. Study completion12 Mar 2019

Resources

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
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03933332
Sponsor's protocol ID
IndonesiaUAnes036
Status last verified
Apr 2019
First submitted
27 Apr 2019
Last updated
2 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Mehta AB, Syeda SN, Wiener RS, Walkey AJ. Epidemiological trends in invasive mechanical ventilation in the United States: A population-based study. J Crit Care. 2015 Dec;30(6):1217-21. doi: 10.1016/j.jcrc.2015.07.007. Epub 2015 Jul 16.

    PubMed 26271686

  • Funk GC, Anders S, Breyer MK, Burghuber OC, Edelmann G, Heindl W, Hinterholzer G, Kohansal R, Schuster R, Schwarzmaier-D'Assie A, Valentin A, Hartl S. Incidence and outcome of weaning from mechanical ventilation according to new categories. Eur Respir J. 2010 Jan;35(1):88-94. doi: 10.1183/09031936.00056909. Epub 2009 Jun 18.

    PubMed 19541716

  • Hill AD, Fowler RA, Burns KE, Rose L, Pinto RL, Scales DC. Long-Term Outcomes and Health Care Utilization after Prolonged Mechanical Ventilation. Ann Am Thorac Soc. 2017 Mar;14(3):355-362. doi: 10.1513/AnnalsATS.201610-792OC.

    PubMed 28033033

  • Carson SS, Garrett J, Hanson LC, Lanier J, Govert J, Brake MC, Landucci DL, Cox CE, Carey TS. A prognostic model for one-year mortality in patients requiring prolonged mechanical ventilation. Crit Care Med. 2008 Jul;36(7):2061-9. doi: 10.1097/CCM.0b013e31817b8925.

    PubMed 18552692

  • Kim WY, Jo EJ, Eom JS, Mok J, Kim MH, Kim KU, Park HK, Lee MK, Lee K. Validation of the Prognosis for Prolonged Ventilation (ProVent) score in patients receiving 14days of mechanical ventilation. J Crit Care. 2018 Apr;44:249-254. doi: 10.1016/j.jcrc.2017.11.029. Epub 2017 Nov 23.

    PubMed 29202432

  • Clark PA, Inocencio RC, Lettieri CJ. I-TRACH: Validating A Tool for Predicting Prolonged Mechanical Ventilation. J Intensive Care Med. 2018 Oct;33(10):567-573. doi: 10.1177/0885066616679974. Epub 2016 Nov 30.

    PubMed 27899470

  • Clark PA, Lettieri CJ. Clinical model for predicting prolonged mechanical ventilation. J Crit Care. 2013 Oct;28(5):880.e1-7. doi: 10.1016/j.jcrc.2013.03.013. Epub 2013 May 14.

    PubMed 23683556

  • Latronico N, Gosselink R. A guided approach to diagnose severe muscle weakness in the intensive care unit. Rev Bras Ter Intensiva. 2015 Jul-Sep;27(3):199-201. doi: 10.5935/0103-507X.20150036. Epub 2015 Sep 15. No abstract available.

    PubMed 26376161

  • Latronico N, Piva S, McCredie V. Long-term implication of icu-acquired muscle weakness. In: Stevens RD, Hart N, Herridge MS, editors. Textbook of post-icu medicine. Oxford, UK: Oxford University Press; 2014. p. 259-68.

  • Stevens RD, Marshall SA, Cornblath DR, Hoke A, Needham DM, de Jonghe B, Ali NA, Sharshar T. A framework for diagnosing and classifying intensive care unit-acquired weakness. Crit Care Med. 2009 Oct;37(10 Suppl):S299-308. doi: 10.1097/CCM.0b013e3181b6ef67.

    PubMed 20046114

  • Vincent JL, Norrenberg M. Intensive care unit-acquired weakness: framing the topic. Crit Care Med. 2009 Oct;37(10 Suppl):S296-8. doi: 10.1097/CCM.0b013e3181b6f1e1.

    PubMed 20046113

  • Hermans G, Van den Berghe G. Clinical review: intensive care unit acquired weakness. Crit Care. 2015 Aug 5;19(1):274. doi: 10.1186/s13054-015-0993-7.

    PubMed 26242743

  • Farhan H, Moreno-Duarte I, Latronico N, Zafonte R, Eikermann M. Acquired Muscle Weakness in the Surgical Intensive Care Unit: Nosology, Epidemiology, Diagnosis, and Prevention. Anesthesiology. 2016 Jan;124(1):207-34. doi: 10.1097/ALN.0000000000000874.

    PubMed 26445385

  • Latronico N, Herridge M, Hopkins RO, Angus D, Hart N, Hermans G, Iwashyna T, Arabi Y, Citerio G, Ely EW, Hall J, Mehta S, Puntillo K, Van den Hoeven J, Wunsch H, Cook D, Dos Santos C, Rubenfeld G, Vincent JL, Van den Berghe G, Azoulay E, Needham DM. The ICM research agenda on intensive care unit-acquired weakness. Intensive Care Med. 2017 Sep;43(9):1270-1281. doi: 10.1007/s00134-017-4757-5. Epub 2017 Mar 13.

    PubMed 28289812

  • Annetta MG, Pittiruti M, Silvestri D, Grieco DL, Maccaglia A, La Torre MF, Magarelli N, Mercurio G, Caricato A, Antonelli M. Ultrasound assessment of rectus femoris and anterior tibialis muscles in young trauma patients. Ann Intensive Care. 2017 Oct 6;7(1):104. doi: 10.1186/s13613-017-0326-x.

    PubMed 28986861

Questions about this trial

What is this clinical trial studying?

An observational study of Ventilation Therapy; Complications, run by Universitas Indonesia at 1 site in Indonesia.

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 1 inclusion and 8 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 2 May 2019. 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 Indonesia. 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?

Correlation between changes in diaphragm thickness with ventilator length of use (time frame: 30 days from admission). The study lists 4 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 NCT03933332, which also lists 20 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 2 May 2019.

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