The SOMNUS Study: Sedative Optimization Via Monitoring Neurological Status

NCT00469482 | Completed DMC

• 2 other identifiers: 061218SOMNUS
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

A combined strategy of Richmond Agitation and Sedation Scale (RASS) clinical targeting plus bispectral index (BIS) guided sedation in mechanically ventilated, critically ill patients will decrease time on mechanical ventilation, decrease the duration of intensive care unit (ICU) delirium and coma, and will improve subacute neurocognitive function when compared to sedation guided by RASS targeting alone.

Conditions

Delirium; Cognitive Impairment; Critically Ill

Keywords

Delirium; Cognitive Impairment; Sleep; Polysomnography; Sedation; Mechanical Ventilation; Critical Illness

Outcome Measures

Primary Outcomes (1)

• Number of ventilator free hours and days

  while in ICU, appoximately 3-7 days

Secondary Outcomes (16)

• Number of delirium and coma free days

  while in ICU, appoximately 3-7 days)

• Incidence of subacute cognitive dysfunction using RBANS- Repeatable Battery for the Assessment of Neuropsychological Status,

  3 months

• Incidence of subacute cognitive dysfunction using TRAILS A&B

  3 months

• Incidence of subacute cognitive dysfunction using SF-36 - Short Form Health Survey

  3 months

• Incidence of subacute cognitive dysfunction using MMSE - Mini Mental State Examination

  3 months

Study Arms (2)

Sedation, RASS Targeted

ACTIVE COMPARATOR

Patient sedation utilizing standard of care methods (RASS Targeted)

Other: Sedation, RASS Targeted

Sedation,RASS Targeted plus BIS Monitoring

ACTIVE COMPARATOR

Providing patient sedation utilizing standard of care methods (RASS) plus BIS monitoring.

Other: Sedation,RASS Targeted plus BIS Monitoring

Interventions

Sedation,RASS Targeted plus BIS Monitoring OTHER

Providing patient sedation utilizing standard of care methods (RASS) plus BIS monitoring

Sedation,RASS Targeted plus BIS Monitoring

Sedation, RASS Targeted OTHER

Patient sedation utilizing standard of care methods (RASS targeted)

Sedation, RASS Targeted

Eligibility Criteria

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

You may qualify if:

• Male or female adult patients admitted to the ICU for critical illnesses requiring mechanical ventilation with expectation of being mechanically ventilated for greater than 24 hours. Subjects must have an actual or a target RASS of -3 or deeper with 48 hours of initiation of mechanical ventilation.

You may not qualify if:

• Subjects who are less than 18 years old.
• Inability to obtain informed consent from the patient or his/her surrogate.
• Subjects admitted with alcohol or drug overdoses, suicide attempts, or alcohol/delirium with tremors.
• Subjects with documented moderate to severe dementia.
• Subjects with anoxic brain injuries, strokes, neurotrauma, or neuromuscular disorders such as myasthenia gravis or Guillain Barre syndrome.
• Subjects whose family and/or physician have not committed to aggressive support for 72 hours or who are likely to withdraw within 72 hours.
• Subjects who are moribund or are not expected to survive hospital discharge due to preexisting uncorrectable medical condition.
• Subjects who have either Child-Pugh Class B or C cirrhosis.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (19)

• Marcantonio ER, Juarez G, Goldman L, Mangione CM, Ludwig LE, Lind L, Katz N, Cook EF, Orav EJ, Lee TH. The relationship of postoperative delirium with psychoactive medications. JAMA. 1994 Nov 16;272(19):1518-22.

  PMID: 7966844 BACKGROUND

• Pandharipande P, Shintani A, Peterson J, Pun BT, Wilkinson GR, Dittus RS, Bernard GR, Ely EW. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006 Jan;104(1):21-6. doi: 10.1097/00000542-200601000-00005.

  PMID: 16394685 BACKGROUND

• Inouye SK, Schlesinger MJ, Lydon TJ. Delirium: a symptom of how hospital care is failing older persons and a window to improve quality of hospital care. Am J Med. 1999 May;106(5):565-73. doi: 10.1016/s0002-9343(99)00070-4.

  PMID: 10335730 BACKGROUND

• Dubois MJ, Bergeron N, Dumont M, Dial S, Skrobik Y. Delirium in an intensive care unit: a study of risk factors. Intensive Care Med. 2001 Aug;27(8):1297-304. doi: 10.1007/s001340101017.

  PMID: 11511942 BACKGROUND

• Inouye SK, Charpentier PA. Precipitating factors for delirium in hospitalized elderly persons. Predictive model and interrelationship with baseline vulnerability. JAMA. 1996 Mar 20;275(11):852-7.

  PMID: 8596223 BACKGROUND

• Ely EW, Gautam S, Margolin R, Francis J, May L, Speroff T, Truman B, Dittus R, Bernard R, Inouye SK. The impact of delirium in the intensive care unit on hospital length of stay. Intensive Care Med. 2001 Dec;27(12):1892-900. doi: 10.1007/s00134-001-1132-2. Epub 2001 Nov 8.

  PMID: 11797025 BACKGROUND

• Ely EW, Shintani A, Truman B, Speroff T, Gordon SM, Harrell FE Jr, Inouye SK, Bernard GR, Dittus RS. Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA. 2004 Apr 14;291(14):1753-62. doi: 10.1001/jama.291.14.1753.

  PMID: 15082703 BACKGROUND

• Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.

  PMID: 15071384 BACKGROUND

• Jackson JC, Gordon SM, Hart RP, Hopkins RO, Ely EW. The association between delirium and cognitive decline: a review of the empirical literature. Neuropsychol Rev. 2004 Jun;14(2):87-98. doi: 10.1023/b:nerv.0000028080.39602.17.

  PMID: 15264710 BACKGROUND

• Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. doi: 10.1097/00003246-200201000-00020. No abstract available.

  PMID: 11902253 BACKGROUND

• Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8. doi: 10.1378/chest.114.2.541.

  PMID: 9726743 BACKGROUND

• 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 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.

  PMID: 10816184 BACKGROUND

• 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. doi: 10.1136/bmj.290.6474.1029.

  PMID: 3921096 BACKGROUND

• 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. doi: 10.1378/chest.117.3.809.

  PMID: 10713011 BACKGROUND

• Sleigh JW, Andrzejowski J, Steyn-Ross A, Steyn-Ross M. The bispectral index: a measure of depth of sleep? Anesth Analg. 1999 Mar;88(3):659-61. doi: 10.1097/00000539-199903000-00035.

  PMID: 10072023 BACKGROUND

• Grocott HP, Newman MF, El-Moalem H, Bainbridge D, Butler A, Laskowitz DT. Apolipoprotein E genotype differentially influences the proinflammatory and anti-inflammatory response to cardiopulmonary bypass. J Thorac Cardiovasc Surg. 2001 Sep;122(3):622-3. doi: 10.1067/mtc.2001.115152. No abstract available.

  PMID: 11547323 BACKGROUND

• Weigand MA, Volkmann M, Schmidt H, Martin E, Bohrer H, Bardenheuer HJ. Neuron-specific enolase as a marker of fatal outcome in patients with severe sepsis or septic shock. Anesthesiology. 2000 Mar;92(3):905-7. doi: 10.1097/00000542-200003000-00057. No abstract available.

  PMID: 10719986 BACKGROUND

• Hopkins RO, Weaver LK, Pope D, Orme JF, Bigler ED, Larson-LOHR V. Neuropsychological sequelae and impaired health status in survivors of severe acute respiratory distress syndrome. Am J Respir Crit Care Med. 1999 Jul;160(1):50-6. doi: 10.1164/ajrccm.160.1.9708059.

  PMID: 10390379 BACKGROUND

• Norris PR, Dawant BM. Closing the loop in ICU decision support: physiologic event detection, alerts, and documentation. Proc AMIA Symp. 2001:498-502.

  PMID: 11825238 BACKGROUND

Related Links

• This is an educational website about ICU delirium.

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction; Critical Illness

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Wes Ely, MD

  Vanderbilt Universtiy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 4, 2007
• Study Start: June 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: September 1, 2016
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

US (1)