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

NCT03933332 | Completed

• 1 other identifier: IndonesiaUAnes036
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ventilation Therapy; Complications

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Ventilator length of use

  30 days from admission

• Changes in diaphragm thickness

  5 days from admission

• Changes in cross-sectional area of rectus femoris muscle

  5 days from admission

• Changes in cross-sectional area of biceps brachii muscle

  5 days from admission

• Changes in quantitative C-reactive protein (CRP) levels

  5 days from admission

Study Arms (1)

Ventilator length of use

measured in days

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

Interventions

Diaphragm thickness OTHER

measured at apposition zone using ultrasonography in mm

Ventilator length of use

Cross-sectional area of rectus femoris muscle OTHER

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

Ventilator length of use

Cross-sectional area of biceps brachii OTHER

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

Ventilator length of use

C-Reactive Protein (CRP) Level DIAGNOSTIC_TEST

quantitative CRP using ELISA method in mcg/mL

Ventilator length of use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (20)

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  PMID: 26271686 BACKGROUND

• 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.

  PMID: 19541716 BACKGROUND

• 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.

  PMID: 28033033 BACKGROUND

• 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.

  PMID: 18552692 BACKGROUND

• 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.

  PMID: 29202432 BACKGROUND

• 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.

  PMID: 27899470 BACKGROUND

• 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.

  PMID: 23683556 BACKGROUND

• 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.

  PMID: 26376161 BACKGROUND

• 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.

  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.

  PMID: 20046114 BACKGROUND

• 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.

  PMID: 20046113 BACKGROUND

• 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.

  PMID: 26242743 BACKGROUND

• 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.

  PMID: 26445385 BACKGROUND

• 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.

  PMID: 28289812 BACKGROUND

• 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.

  PMID: 28986861 BACKGROUND

• 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.

  PMID: 29110031 BACKGROUND

• 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.

  PMID: 24108501 BACKGROUND

• 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.

  PMID: 27620292 BACKGROUND

• 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.

  PMID: 28887062 BACKGROUND

• 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.

  PMID: 28149877 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Anesthesiologist Consultant

Study Record Dates

• First Submitted: April 27, 2019
• First Posted: May 1, 2019
• Study Start: October 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: March 12, 2019
• Last Updated: May 2, 2019

Record last verified: 2019-04

Locations

ID (1)