Enteral vs. intravenous ICU sedation management: Study protocol for a randomized controlled trial

Trials

Volumn 14, Issue 1, 2013, Pages

  Mistraletti, Giovanni ^a   Mantovani, Elena S ^a   Cadringher, Paolo ^a   Cerri, Barbara ^a   Corbella, Davide ^b   Umbrello, Michele ^a   Anania, Stefania ^a   Andrighi, Elisa ^a   Barello, Serena ^a   Carlo, Alessandra D ^a   Martinetti, Federica ^a   Formenti, Paolo ^a   Spanu, Paolo ^a   Iapichino, Gaetano ^a  

^a UNIVERSITY OF MILAN   (Italy)

^b OSPEDALI RIUNITI   (Italy)

Author keywords

Educational research; Enteral approach; High risk critically ill; Hydroxyzine; Melatonin; Sedation

Indexed keywords

HYDROXYZINE; LORAZEPAM; MELATONIN; MIDAZOLAM; PROPOFOL;

AGITATION; ANESTHESIA LEVEL; ARTICLE; COMPUTER PROGRAM; CONTROLLED STUDY; CRITICALLY ILL PATIENT; DEEP SEDATION; DELIRIUM; ENTERIC FEEDING; HIGH RISK PATIENT; HUMAN; INTENSIVE CARE UNIT; ITALY; MAJOR CLINICAL STUDY; MEDICAL EDUCATION; MEDICAL STAFF; MULTICENTER STUDY; NEUROMONITORING; OUTCOME ASSESSMENT; PAIN; RANDOMIZED CONTROLLED TRIAL; RICHMOND AGITATION SEDATION SCALE; SINGLE BLIND PROCEDURE; WEB BROWSER;

ADMINISTRATION, ORAL; ANESTHETICS, INTRAVENOUS; CLINICAL PROTOCOLS; COMPUTER-ASSISTED INSTRUCTION; CONSCIOUS SEDATION; CONSCIOUSNESS; CRITICAL ILLNESS; DRUG THERAPY, COMBINATION; EDUCATION, MEDICAL, CONTINUING; HUMANS; HYDROXYZINE; HYPNOTICS AND SEDATIVES; INFUSIONS, INTRAVENOUS; INSERVICE TRAINING; INTENSIVE CARE UNITS; INTERNET; ITALY; LORAZEPAM; MELATONIN; MIDAZOLAM; PROPOFOL; RESEARCH DESIGN; SINGLE-BLIND METHOD; TREATMENT OUTCOME;

EID: 84875654238     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-92     Document Type: Article

References (40)

1. Fraser GL, Riker RR. Sedation and analgesia in the critically ill adult. Curr Opin Anaesthesiol 2007, 20:119-123. 10.1097/ACO.0b013e32808255b4, 17413394.
2. Martin J, Heymann A, Basell K, Baron R, Biniek R, Burkle H, Dall P, Dictus C, Eggers V, Eichler I, Engelmann L, Garten L, Hartl W, Haase U, Huth R, Kessler P, Kleinschmidt S, Koppert W, Kretz FJ, Laubenthal H, Marggraf G, Meiser A, Neugebauer E, Neuhaus U, Putensen C, Quintel M, Reske A, Roth B, Scholz J, Schroder S. Evidence and consensus-based German guidelines for the management of analgesia, sedation and delirium in intensive care-short version. Ger Med Sci 2010, 8:Doc02. 2830566, 20200655.
3. Riker RR, Fraser GL. Adverse events associated with sedatives, analgesics, and other drugs that provide patient comfort in the intensive care unit. Pharmacotherapy 2005, 25:8S-18S. 10.1592/phco.2005.25.5_Part_2.8S, 15899744.
4. Cigada M, Corbella D, Mistraletti G, Forster CR, Tommasino C, Morabito A, Iapichino G. Conscious sedation in the critically ill ventilated patient. J Crit Care 2008, 23:349-353. 10.1016/j.jcrc.2007.04.003, 18725039.
5. De Jonghe B, Bastuji-Garin S, Fangio P, Lacherade JC, Jabot J, Appere-De-Vecchi C, Rocha N, Outin H. Sedation algorithm in critically ill patients without acute brain injury. Crit Care Med 2005, 33:120-127. 10.1097/01.CCM.0000150268.04228.68, 15644658.
6. Sessler CN, Varney K. Patient-focused sedation and analgesia in the ICU. Chest 2008, 133:552-565. 10.1378/chest.07-2026, 18252923.
7. Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med 2000, 342:1471-1477. 10.1056/NEJM200005183422002, 10816184.
8. Girard TD, Kress JP, Fuchs BD, Thomason JW, Schweickert WD, Pun BT, Taichman DB, Dunn JG, Pohlman AS, Kinniry PA, Jackson JC, Canonico AE, Light RW, Shintani AK, Thompson JL, Gordon SM, Hall JB, Dittus RS, Bernard GR, Ely EW. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. Lancet 2008, 371:126-134. 10.1016/S0140-6736(08)60105-1, 18191684.
9. Breen D, Karabinis A, Malbrain M, Morais R, Albrecht S, Jarnvig IL, Parkinson P, Kirkham AJ. Decreased duration of mechanical ventilation when comparing analgesia-based sedation using remifentanil with standard hypnotic-based sedation for up to 10 days in intensive care unit patients: a randomised trial [ISRCTN47583497]. Crit Care 2005, 9:R200-R210. 10.1186/cc3495, 1175879, 15987391.
10. Spies C, Macguill M, Heymann A, Ganea C, Krahne D, Assman A, Kosiek HR, Scholtz K, Wernecke KD, Martin J. A prospective, randomized, double-blind, multicenter study comparing remifentanil with fentanyl in mechanically ventilated patients. Intensive Care Med 2011, 37:469-476. 10.1007/s00134-010-2100-5, 21165734.
11. Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet 2010, 375:475-480. 10.1016/S0140-6736(09)62072-9, 20116842.
12. Chevron V, Menard JF, Richard JC, Girault C, Leroy J, Bonmarchand G. Unplanned extubation: risk factors of development and predictive criteria for reintubation. Crit Care Med 1998, 26:1049-1053. 10.1097/00003246-199806000-00026, 9635654.
13. Guttormson JL, Chlan L, Weinert C, Savik K. Factors influencing nurse sedation practices with mechanically ventilated patients: a U.S. national survey. Intensive Crit Care Nurs 2010, 26:44-50. 10.1016/j.iccn.2009.10.004, 19945879.
14. Goodwin H, Lewin JJ, Mirski MA. 'Cooperative sedation': optimizing comfort while maximizing systemic and neurological function. Crit Care 2012, 16:217. 10.1186/cc11231, 22429840.
15. Martin J, Franck M, Fischer M, Spies C. Sedation and analgesia in German intensive care units: how is it done in reality? Results of a patient-based survey of analgesia and sedation. Intensive Care Med 2006, 32:1137-1142. 10.1007/s00134-006-0214-6, 16741692.
16. Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology 2007, 106:687-695. quiz, 891-892, 10.1097/01.anes.0000264747.09017.da, 17413906.
17. Devlin JW. The pharmacology of oversedation in mechanically ventilated adults. Curr Opin Crit Care 2008, 14:403-407. 10.1097/MCC.0b013e32830280b3, 18614903.
18. Reschreiter H, Maiden M, Kapila A. Sedation practice in the intensive care unit: a UK national survey. Crit Care 2008, 12:R152. 10.1186/cc7141, 2646317, 19046459.
19. Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med 2002, 166:1338-1344. 10.1164/rccm.2107138, 12421743.
20. Schweickert WD, Kress JP. Strategies to optimize analgesia and sedation. Crit Care 2008, Suppl 3:S6.
21. Jones C, Griffiths RD, Humphris G, Skirrow PM. Memory, delusions, and the development of acute posttraumatic stress disorder-related symptoms after intensive care. Crit Care Med 2001, 29:573-580. 10.1097/00003246-200103000-00019, 11373423.
22. Mistraletti G, Sabbatini G, Taverna M, Figini MA, Umbrello M, Magni P, Ruscica M, Dozio E, Esposti R, DeMartini G, Fraschini F, Rezzani R, Reiter RJ, Iapichino G. Pharmacokinetics of orally administered melatonin in critically ill patients. J Pineal Res 2010, 48:142-147. 10.1111/j.1600-079X.2009.00737.x, 20070489.
23. Iapichino G, Pesenti A, Radrizzani D, Solca M, Pelizzola A, Gattinoni L. Nutritional support to long-term anesthetized and curarized patients under extracorporeal respiratory assist for terminal pulmonary failure. JPEN J Parenter Enteral Nutr 1983, 7:50-54. 10.1177/014860718300700150, 6403732.
24. Cigada M, Pezzi A, Di Mauro P, Marzorati S, Noto A, Valdambrini F, Zaniboni M, Astori M, Iapichino G. Sedation in the critically ill ventilated patient: possible role of enteral drugs. Intensive Care Med 2005, 31:482-486. 10.1007/s00134-005-2559-7, 15714324.
25. Bellapart J, Boots R. Potential use of melatonin in sleep and delirium in the critically ill. Br J Anaesth 2012, 108:572-580. 10.1093/bja/aes035, 22419624.
26. Iapichino G, Mistraletti G, Corbella D, Bassi G, Borotto E, Miranda DR, Morabito A. Scoring system for the selection of high-risk patients in the intensive care unit. Crit Care Med 2006, 34:1039-1043. 10.1097/01.CCM.0000206286.19444.40, 16484895.
27. Bourne RS, Mills GH, Minelli C. Melatonin therapy to improve nocturnal sleep in critically ill patients: encouraging results from a small randomised controlled trial. Crit Care 2008, 12:R52. 10.1186/cc6871, 2447606, 18423009.
28. Ely EW, Margolin R, Francis J, May L, Truman B, Dittus R, Speroff T, Gautam S, Bernard GR, Inouye SK. Evaluation of delirium in critically ill patients: validation of the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Crit Care Med 2001, 29:1370-1379. 10.1097/00003246-200107000-00012, 11445689.
29. Pandharipande PP, Pun BT, Herr DL, Maze M, Girard TD, Miller RR, Shintani AK, Thompson JL, Jackson JC, Deppen SA, Stiles RA, Dittus RS, Bernard GR, Ely EW. Effect of sedation with dexmedetomidine vs lorazepam on acute brain dysfunction in mechanically ventilated patients: the MENDS randomized controlled trial. JAMA 2007, 298:2644-2653. 10.1001/jama.298.22.2644, 18073360.
30. Riker RR, Shehabi Y, Bokesch PM, Ceraso D, Wisemandle W, Koura F, Whitten P, Margolis BD, Byrne DW, Ely EW, Rocha MG. Dexmedetomidine vs midazolam for sedation of critically ill patients: a randomized trial. JAMA 2009, 301:489-499. 10.1001/jama.2009.56, 19188334.
31. Ahlers SJ, van der Veen AM, van Dijk M, Tibboel D, Knibbe CA. The use of the Behavioral Pain Scale to assess pain in conscious sedated patients. Anesth Analg 2010, 110:127-133. 10.1213/ANE.0b013e3181c3119e, 19897804.
32. Kreymann KG, Berger MM, Deutz NE, Hiesmayr M, Jolliet P, Kazandjiev G, Nitenberg G, van den Berghe G, Wernerman J, Ebner C, Hartl W, Heymann C, Spies C. ESPEN Guidelines on Enteral Nutrition: Intensive care. Clin Nutr 2006, 25:210-223. 10.1016/j.clnu.2006.01.021, 16697087.
33. Altman DG, Bland JM. Treatment allocation by minimisation. BMJ 2005, 330:843. 10.1136/bmj.330.7495.843, 556084, 15817555.
34. Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA 1993, 270:2957-2963. 10.1001/jama.1993.03510240069035, 8254858.
35. Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med 1996, 22:707-710. 10.1007/BF01709751, 8844239.
36. Iapichino G, Radrizzani D, Bertolini G, Ferla L, Pasetti G, Pezzi A, Porta F, Miranda DR. Daily classification of the level of care. A method to describe clinical course of illness, use of resources and quality of intensive care assistance. Intensive Care Med 2001, 27:131-136. 10.1007/s001340000776, 11280624.
37. Pandharipande PP, Sanders RD, Girard TD, McGrane S, Thompson JL, Shintani AK, Herr DL, Maze M, Ely EW. Effect of dexmedetomidine versus lorazepam on outcome in patients with sepsis: an a priori-designed analysis of the MENDS randomized controlled trial. Crit Care 2010, 14:R38. 10.1186/cc8916, 2887145, 20233428.
38. Inouye SK. Delirium in older persons. N Engl J Med 2006, 354:1157-1165. 10.1056/NEJMra052321, 16540616.
39. Zeger SL, Liang KY. An overview of methods for the analysis of longitudinal data. Stat Med 1992, 11:1825-1839. 10.1002/sim.4780111406, 1480876.
40. Mattia C, Savoia G, Paoletti F, Piazza O, Albanese D, Amantea B, Ambrosio F, Belfiore B, Berti M, Bertini L, Bruno F, Carassiti M, Celleno D, Coluzzi F, Consales G, Costantini A, Cuppini F, De Gaudio RA, Farnia A, Finco G, Gravino E, Guberti A, Laurenzi L, Mangione S, Marano M, Mariconda G, Martorano PP, Mediati R, Mercieri M, Mondello E. SIAARTI recommendations for analgo-sedation in intensive care unit. Minerva Anestesiol 2006, 72:769-805.