Correlation Between Muscle Thickness and Inflammation With Ventilator Use in Critically Ill Patients
2019年4月30日 更新者：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
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
52
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
DKI Jakarta
-
Jakarta Pusat、DKI Jakarta、印度尼西亚、10430
- Rumah Sakit Cipto Mangunkusumo
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Critically-ill patients admitted to Intensive Care Units of Cipto Mangunkusumo Hospital using ventilator on October 2018 - December 2018
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between changes in diaphragm thickness with ventilator length of use
大体时间：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
大体时间：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
大体时间：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
|
|
Correlation between changes in quantitative C-reactive protein (CRP) level with ventilator length of use
大体时间：30 days from admission
|
Correlation between changes in quantitative C-reactive protein (CRP) level with ventilator length of use: < 7 days or >7 days
|
30 days from admission
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ventilator length of use
大体时间：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
大体时间：5 days from admission
|
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
|
5 days from admission
|
|
Changes in cross-sectional area of rectus femoris muscle
大体时间：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
大体时间：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
大体时间：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
|
5 days from admission
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年10月1日
初级完成 (实际的)
2019年1月31日
研究完成 (实际的)
2019年3月12日
研究注册日期
首次提交
2019年4月27日
首先提交符合 QC 标准的
2019年4月27日
首次发布 (实际的)
2019年5月1日
研究记录更新
最后更新发布 (实际的)
2019年5月2日
上次提交的符合 QC 标准的更新
2019年4月30日
最后验证
2019年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.