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

Ventilation Therapy; Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03933332
• Other study ID #: IndonesiaUAnes036
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: March 12, 2019

Study information

• Verified date: April 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 12, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Inflammation
• Ventilation Therapy; Complications

Intervention

Other:
• Diaphragm thickness
measured at apposition zone using ultrasonography in mm
• 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
• Cross-sectional area of biceps brachii
measured at biceps brachii muscle using ultrasonography in cm^2

Diagnostic Test:
• C-Reactive Protein (CRP) Level
quantitative CRP using ELISA method in mcg/mL

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (20)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Hermans G, Van den Berghe G. Clinical review: intensive care unit acquired weakness. Crit Care. 2015 Aug 5;19:274. doi: 10.1186/s13054-015-0993-7. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. English, Portuguese. — View Citation

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. Review. — View Citation

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.

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. — View Citation

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. — View Citation

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. Erratum in: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul]. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days from admission
Primary	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	30 days from admission
Primary	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	30 days from admission
Primary	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	30 days from admission
Secondary	Ventilator length of use	duration of first ventilator use until patient is extubated or deceased: <7 days or >7 days	30 days from admission
Secondary	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; : decrease thickness of <20%; : decrease thickness of >20%	5 days from admission
Secondary	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; : decrease cross-sectional area of <20%; : decrease cross-sectional area of >20%	5 days from admission
Secondary	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; : decrease cross-sectional area of <20%; : decrease cross-sectional area of >20%	5 days from admission
Secondary	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; : increase in quantitative CRP <50%; : increase in quantitative CRP >50%	5 days from admission