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

NCT ID: NCT03933332

Last Updated: 2019-05-02

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-03-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ventilation Therapy; Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ventilator length of use

measured in days

Diaphragm thickness

Intervention Type OTHER

measured at apposition zone using ultrasonography in mm

Cross-sectional area of rectus femoris muscle

Intervention Type OTHER

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 brachii

Intervention Type OTHER

measured at biceps brachii muscle using ultrasonography in cm\^2

C-Reactive Protein (CRP) Level

Intervention Type DIAGNOSTIC_TEST

quantitative CRP using ELISA method in mcg/mL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diaphragm thickness

measured at apposition zone using ultrasonography in mm

Intervention Type OTHER

Cross-sectional area of rectus femoris muscle

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

Intervention Type OTHER

Cross-sectional area of biceps brachii

measured at biceps brachii muscle using ultrasonography in cm\^2

Intervention Type OTHER

C-Reactive Protein (CRP) Level

quantitative CRP using ELISA method in mcg/mL

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dita Aditianingsih

MD, PhD, Anesthesiologist Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26271686 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19541716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28033033 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18552692 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29202432 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27899470 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23683556 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26376161 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 20046114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20046113 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26242743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26445385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28289812 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28986861 (View on PubMed)

Nakanishi N, Oto J, Tsutsumi R, Iuchi M, Onodera M, Nishimura M. Upper and lower limb muscle atrophy in critically ill patients: an observational ultrasonography study. Intensive Care Med. 2018 Feb;44(2):263-264. doi: 10.1007/s00134-017-4975-x. Epub 2017 Nov 6. No abstract available.

Reference Type BACKGROUND
PMID: 29110031 (View on PubMed)

Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481.

Reference Type BACKGROUND
PMID: 24108501 (View on PubMed)

Zambon M, Greco M, Bocchino S, Cabrini L, Beccaria PF, Zangrillo A. Assessment of diaphragmatic dysfunction in the critically ill patient with ultrasound: a systematic review. Intensive Care Med. 2017 Jan;43(1):29-38. doi: 10.1007/s00134-016-4524-z. Epub 2016 Sep 12.

Reference Type BACKGROUND
PMID: 27620292 (View on PubMed)

Supinski GS, Morris PE, Dhar S, Callahan LA. Diaphragm Dysfunction in Critical Illness. Chest. 2018 Apr;153(4):1040-1051. doi: 10.1016/j.chest.2017.08.1157. Epub 2017 Sep 5.

Reference Type BACKGROUND
PMID: 28887062 (View on PubMed)

Jorens PG, Schepens T. Ultrasound: a novel translational tool to study diaphragmatic dysfunction in critical illness. Ann Transl Med. 2016 Dec;4(24):515. doi: 10.21037/atm.2016.12.49. No abstract available.

Reference Type BACKGROUND
PMID: 28149877 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IndonesiaUAnes036

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.