Correlation Between Muscle Thickness and Inflammation With Ventilator Use in Critically Ill Patients
30. april 2019 oppdatert av: Dita Aditianingsih, Indonesia University
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
Studieoversikt
Status
Fullført
Studietype
Observasjonsmessig
Registrering (Faktiske)
52
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Indonesia, 10430
- Rumah Sakit Cipto Mangunkusumo
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Critically-ill patients admitted to Intensive Care Units of Cipto Mangunkusumo Hospital using ventilator on October 2018 - December 2018
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Ventilator length of use
measured in days
|
measured at apposition zone using ultrasonography in mm
measured at lower one-third line between Spina iliaca anterior inferior (SIAI) and upper border femur patella using ultrasonography in cm^2
measured at biceps brachii muscle using ultrasonography in cm^2
quantitative CRP using ELISA method in mcg/mL
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation between changes in diaphragm thickness with ventilator length of use
Tidsramme: 30 days from admission
|
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
Tidsramme: 30 days from admission
|
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
Tidsramme: 30 days from admission
|
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
|
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Correlation between changes in quantitative C-reactive protein (CRP) level with ventilator length of use
Tidsramme: 30 days from admission
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Correlation between changes in quantitative C-reactive protein (CRP) level with ventilator length of use: < 7 days or >7 days
|
30 days from admission
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Ventilator length of use
Tidsramme: 30 days from admission
|
duration of first ventilator use until patient is extubated or deceased: <7 days or >7 days
|
30 days from admission
|
|
Changes in diaphragm thickness
Tidsramme: 5 days from admission
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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
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5 days from admission
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Changes in cross-sectional area of rectus femoris muscle
Tidsramme: 5 days from admission
|
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
|
5 days from admission
|
|
Changes in cross-sectional area of biceps brachii muscle
Tidsramme: 5 days from admission
|
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
|
5 days from admission
|
|
Changes in quantitative C-reactive protein (CRP) levels
Tidsramme: 5 days from admission
|
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
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5 days from admission
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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. Erratum In: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul].
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. oktober 2018
Primær fullføring (Faktiske)
31. januar 2019
Studiet fullført (Faktiske)
12. mars 2019
Datoer for studieregistrering
Først innsendt
27. april 2019
Først innsendt som oppfylte QC-kriteriene
27. april 2019
Først lagt ut (Faktiske)
1. mai 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. mai 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. april 2019
Sist bekreftet
1. april 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IndonesiaUAnes036
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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