Clinical trial NCT03335527 - References

Mechanical Ventilation Complication — Impacts of Low-Dose Dexmedetomidine on Sleep Quality in Mechanically Ventilated ICU Patients

Citation(s)

•   Alexopoulou C, Kondili E, Diamantaki E, Psarologakis C, Kokkini S, Bolaki M, Georgopoulos D
  Effects of dexmedetomidine on sleep quality in critically ill patients: a pilot study. Anesthesiology. 2014 Oct;121(4):801-7. doi: 10.1097/ALN.0000000000000361.
•   Aurell J, Elmqvist D
  Sleep in the surgical intensive care unit: continuous polygraphic recording of sleep in nine patients receiving postoperative care. Br Med J (Clin Res Ed). 1985 Apr 6;290(6474):1029-32.
•   Balzer F, Weiß B, Kumpf O, Treskatsch S, Spies C, Wernecke KD, Krannich A, Kastrup M
  Early deep sedation is associated with decreased in-hospital and two-year follow-up survival. Crit Care. 2015 Apr 28;19:197. doi: 10.1186/s13054-015-0929-2.
•   Combes A, Costa MA, Trouillet JL, Baudot J, Mokhtari M, Gibert C, Chastre J
  Morbidity, mortality, and quality-of-life outcomes of patients requiring >or=14 days of mechanical ventilation. Crit Care Med. 2003 May;31(5):1373-81.
•   Cooper AB, Thornley KS, Young GB, Slutsky AS, Stewart TE, Hanly PJ
  Sleep in critically ill patients requiring mechanical ventilation. Chest. 2000 Mar;117(3):809-18. Erratum in: Chest 2001 Mar;119(3):993.
•   Elliott R, McKinley S, Cistulli P, Fien M
  Characterisation of sleep in intensive care using 24-hour polysomnography: an observational study. Crit Care. 2013 Mar 18;17(2):R46. doi: 10.1186/cc12565.
•   Elliott R, McKinley S, Cistulli P
  The quality and duration of sleep in the intensive care setting: an integrative review. Int J Nurs Stud. 2011 Mar;48(3):384-400. doi: 10.1016/j.ijnurstu.2010.11.006. Epub 2010 Dec 24. Review.
•   Fanfulla F, Ceriana P, D'Artavilla Lupo N, Trentin R, Frigerio F, Nava S
  Sleep disturbances in patients admitted to a step-down unit after ICU discharge: the role of mechanical ventilation. Sleep. 2011 Mar 1;34(3):355-62.
•   Fernandes NM, Nield LE, Popel N, Cantor WJ, Plante S, Goldman L, Prabhakar M, Manlhiot C, McCrindle BW, Miner SE
  Symptoms of disturbed sleep predict major adverse cardiac events after percutaneous coronary intervention. Can J Cardiol. 2014 Jan;30(1):118-24. doi: 10.1016/j.cjca.2013.07.009. Epub 2013 Oct 16.
•   Finan PH, Goodin BR, Smith MT
  The association of sleep and pain: an update and a path forward. J Pain. 2013 Dec;14(12):1539-52. doi: 10.1016/j.jpain.2013.08.007. Review.
•   Freedman NS, Gazendam J, Levan L, Pack AI, Schwab RJ
  Abnormal sleep/wake cycles and the effect of environmental noise on sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 2001 Feb;163(2):451-7.
•   Friese RS, Diaz-Arrastia R, McBride D, Frankel H, Gentilello LM
  Quantity and quality of sleep in the surgical intensive care unit: are our patients sleeping? J Trauma. 2007 Dec;63(6):1210-4. doi: 10.1097/TA.0b013e31815b83d7.
•   Friese RS
  Sleep and recovery from critical illness and injury: a review of theory, current practice, and future directions. Crit Care Med. 2008 Mar;36(3):697-705. doi: 10.1097/CCM.0B013E3181643F29. Review.
•   Gabor JY, Cooper AB, Crombach SA, Lee B, Kadikar N, Bettger HE, Hanly PJ
  Contribution of the intensive care unit environment to sleep disruption in mechanically ventilated patients and healthy subjects. Am J Respir Crit Care Med. 2003 Mar 1;167(5):708-15.
•   Gehlbach BK, Chapotot F, Leproult R, Whitmore H, Poston J, Pohlman M, Miller A, Pohlman AS, Nedeltcheva A, Jacobsen JH, Hall JB, Van Cauter E
  Temporal disorganization of circadian rhythmicity and sleep-wake regulation in mechanically ventilated patients receiving continuous intravenous sedation. Sleep. 2012 Aug 1;35(8):1105-14. doi: 10.5665/sleep.1998.
•   Granja C, Lopes A, Moreira S, Dias C, Costa-Pereira A, Carneiro A; JMIP Study Group
  Patients' recollections of experiences in the intensive care unit may affect their quality of life. Crit Care. 2005 Apr;9(2):R96-109. Epub 2005 Jan 31.
•   Hughes CG, Girard TD, Pandharipande PP
  Daily sedation interruption versus targeted light sedation strategies in ICU patients. Crit Care Med. 2013 Sep;41(9 Suppl 1):S39-45. doi: 10.1097/CCM.0b013e3182a168c5. Review. Erratum in: Crit Care Med. 2013 Nov;41(11):e400.
•   International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use
  ICH harmonized tripartite guideline: Guideline for Good Clinical Practice. J Postgrad Med. 2001 Jan-Mar;47(1):45-50.
•   Kanji S, Mera A, Hutton B, Burry L, Rosenberg E, MacDonald E, Luks V
  Pharmacological interventions to improve sleep in hospitalised adults: a systematic review. BMJ Open. 2016 Jul 29;6(7):e012108. doi: 10.1136/bmjopen-2016-012108. Review.
•   Kjølhede P, Langström P, Nilsson P, Wodlin NB, Nilsson L
  The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.
•   Nedergaard HK, Jensen HI, Lauridsen JT, Sjøgaard G, Toft P
  Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation--effects on physical function: study protocol for a randomized controlled trial: a substudy of the NONSEDA trial. Trials. 2015 Jul 23;16:310. doi: 10.1186/s13063-015-0856-1.
•   Nedergaard HK, Jensen HI, Stylsvig M, Lauridsen JT, Toft P
  Non-sedation versus sedation with a daily wake-up trial in critically ill patients recieving mechanical ventilation - effects on long-term cognitive function: Study protocol for a randomized controlled trial, a substudy of the NONSEDA trial. Trials. 2016 Jun 1;17(1):269. doi: 10.1186/s13063-016-1390-5.
•   Nelson LE, Lu J, Guo T, Saper CB, Franks NP, Maze M
  The alpha2-adrenoceptor agonist dexmedetomidine converges on an endogenous sleep-promoting pathway to exert its sedative effects. Anesthesiology. 2003 Feb;98(2):428-36.
•   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 Dec 12;298(22):2644-53.
•   Parsons EC, Kross EK, Caldwell ES, Kapur VK, McCurry SM, Vitiello MV, Hough CL
  Post-discharge insomnia symptoms are associated with quality of life impairment among survivors of acute lung injury. Sleep Med. 2012 Sep;13(8):1106-9. doi: 10.1016/j.sleep.2012.05.010. Epub 2012 Jul 2.
•   Parthasarathy S, Tobin MJ
  Effect of ventilator mode on sleep quality in critically ill patients. Am J Respir Crit Care Med. 2002 Dec 1;166(11):1423-9. Epub 2002 Sep 5.
•   Porhomayon J, Joude P, Adlparvar G, El-Solh AA, Nader ND
  The Impact of High Versus Low Sedation Dosing Strategy on Cognitive Dysfunction in Survivors of Intensive Care Units: A Systematic Review and Meta-Analysis. J Cardiovasc Thorac Res. 2015;7(2):43-8. doi: 10.15171/jcvtr.2015.10. Review.
•   Schiza SE, Simantirakis E, Bouloukaki I, Mermigkis C, Arfanakis D, Chrysostomakis S, Chlouverakis G, Kallergis EM, Vardas P, Siafakas NM
  Sleep patterns in patients with acute coronary syndromes. Sleep Med. 2010 Feb;11(2):149-53. doi: 10.1016/j.sleep.2009.07.016. Epub 2010 Jan 18.
•   Slatore CG, Goy ER, O'hearn DJ, Boudreau EA, O'Malley JP, Peters D, Ganzini L
  Sleep quality and its association with delirium among veterans enrolled in hospice. Am J Geriatr Psychiatry. 2012 Apr;20(4):317-26. doi: 10.1097/JGP.0b013e3182487680.
•   Stanchina ML, Abu-Hijleh M, Chaudhry BK, Carlisle CC, Millman RP
  The influence of white noise on sleep in subjects exposed to ICU noise. Sleep Med. 2005 Sep;6(5):423-8. Epub 2005 Mar 31.
•   Su X, Meng ZT, Wu XH, Cui F, Li HL, Wang DX, Zhu X, Zhu SN, Maze M, Ma D
  Dexmedetomidine for prevention of delirium in elderly patients after non-cardiac surgery: a randomised, double-blind, placebo-controlled trial. Lancet. 2016 Oct 15;388(10054):1893-1902. doi: 10.1016/S0140-6736(16)30580-3. Epub 2016 Aug 16.
•   Toft P, Olsen HT, Jørgensen HK, Strøm T, Nibro HL, Oxlund J, Wian KA, Ytrebø LM, Kroken BA, Chew M
  Non-sedation versus sedation with a daily wake-up trial in critically ill patients receiving mechanical ventilation (NONSEDA Trial): study protocol for a randomised controlled trial. Trials. 2014 Dec 20;15:499. doi: 10.1186/1745-6215-15-499.
•   Treggiari MM, Romand JA, Yanez ND, Deem SA, Goldberg J, Hudson L, Heidegger CP, Weiss NS
  Randomized trial of light versus deep sedation on mental health after critical illness. Crit Care Med. 2009 Sep;37(9):2527-34. doi: 10.1097/CCM.0b013e3181a5689f.
•   Trompeo AC, Vidi Y, Locane MD, Braghiroli A, Mascia L, Bosma K, Ranieri VM
  Sleep disturbances in the critically ill patients: role of delirium and sedative agents. Minerva Anestesiol. 2011 Jun;77(6):604-12.
•   Weinhouse GL, Watson PL
  Sedation and sleep disturbances in the ICU. Crit Care Clin. 2009 Jul;25(3):539-49, ix. doi: 10.1016/j.ccc.2009.04.003. Review.
•   Wu XH, Cui F, Zhang C, Meng ZT, Wang DX, Ma J, Wang GF, Zhu SN, Ma D
  Low-dose Dexmedetomidine Improves Sleep Quality Pattern in Elderly Patients after Noncardiac Surgery in the Intensive Care Unit: A Pilot Randomized Controlled Trial. Anesthesiology. 2016 Nov;125(5):979-991.
•   Wunsch H, Kahn JM, Kramer AA, Wagener G, Li G, Sladen RN, Rubenfeld GD
  Dexmedetomidine in the care of critically ill patients from 2001 to 2007: an observational cohort study. Anesthesiology. 2010 Aug;113(2):386-94. doi: 10.1097/ALN.0b013e3181e74116.
•   Xia ZQ, Chen SQ, Yao X, Xie CB, Wen SH, Liu KX
  Clinical benefits of dexmedetomidine versus propofol in adult intensive care unit patients: a meta-analysis of randomized clinical trials. J Surg Res. 2013 Dec;185(2):833-43. doi: 10.1016/j.jss.2013.06.062. Epub 2013 Jul 24. Review.

Impact of Low-Dose Dexmedetomidine on Sleep Quality in Mechanical Ventilation Patients After Surgery in Intensive Care Unit: a Pilot Randomized, Double-Blind, Placebo-Controlled Trial

Details for clinical trial NCT03335527