DANish DELIrium Study On Neurointensive Care Patients

NCT02594982 | Completed

• 1 other identifier: H-15007689
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract Background Studies have shown that delirium in medical and surgical intensive care units (ICUs) increases mortality, length of stay (LOS) as well as the risk of dementia symptoms and cerebral atrophy after discharge. Only few studies have investigated delirium in the neurointensive care unit (N-ICU). Delirium is most often assessed by one of two instruments: Intensive Care Delirium Screening Checklist (ICDSC) or the Confusion Assessment Method for the ICU (CAM-ICU). Aims

1. 1.To measure the effect of a systematic intervention (sedation, sleep, mobilization and pain) on delirium symptoms in patients with acute acquired brain injury in N-ICU.
2. 2.To validate the ICDSC and CAM-ICU to patients with acute acquired brain injury Method The design of the study is a two-phase interventional trial. Based on a power calculation, 56 patients will be enrolled both in the baseline and the intervention group (n=112).

Conditions

Acquired Brain Injuries; Delirium; Acute Brain Injury

Keywords

Delirium; intensive care nursing; Acute acquired brain injury; neurointensive care; Intensive care delirium screening checklist; Confusion Assessment Method for the ICU

Outcome Measures

Primary Outcomes (1)

• Duration of delirium symptoms.

  Patients are assessed two times per day for delirium symptoms with ICDSC and the CAM-ICU during their stay on the N-ICU. duration of delirium symptoms measured by CAM-ICU and ICDSC will be analysed individually and the one with the best performance test will be presented as the primary outcome measure.

  Minimum 48 hours and up to 4 weeks

Secondary Outcomes (7)

• Validation of ICDSC and CAM-ICU

  2 days. On the first and second assessable day (RASS -2 or above).

• Prevalence of delirium symptoms

  1 day and up to 4 weeks.

• Length of Stay

  2 days (48 hours) and up til 4 weeks

• Quality of life after 12 month after discharge

  12 month

• Mortality

  1 year

Study Arms (1)

intervention bundle

OTHER

An intervention bundle consisting of optimized sedation, pain assessment and treatment, early mobilization and sleep.

Other: intervention bundle (sedation, pain, mobilization and sleep)

Interventions

intervention bundle (sedation, pain, mobilization and sleep) OTHER

Sedation: Sedation after target RASS Pain: Implementing a pain guideline and CPOT for pain assessment. Mobilization: Implementing a guideline on early mobilization and a daily prescribed mobilization level. Sleep: Implementing a daily quite time and changing procedures to minimize noise during the night

intervention bundle

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Danish speaking adults (18 years or above)
• Expected N-ICU length of stay (LOS) more than 48 hours
• Admitted with acute brain injury from subarachnoid hemorrhage (SAH), intracranial hemorrhage (ICH) or traumatic brain injury (TBI).

You may not qualify if:

• Patients not expected to survive 48 hours
• Richmond Agitation-Sedation Score (RASS) of -4 or -5 during the stay in the N-ICU.

Sponsors & Collaborators

• Kirsten Moller: lead

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Sealand, 2100, Denmark

Location

Related Publications (14)

• Barr J, Fraser GL, Puntillo K, Ely EW, Gelinas C, Dasta JF, Davidson JE, Devlin JW, Kress JP, Joffe AM, Coursin DB, Herr DL, Tung A, Robinson BR, Fontaine DK, Ramsay MA, Riker RR, Sessler CN, Pun B, Skrobik Y, Jaeschke R; American College of Critical Care Medicine. Clinical practice guidelines for the management of pain, agitation, and delirium in adult patients in the intensive care unit. Crit Care Med. 2013 Jan;41(1):263-306. doi: 10.1097/CCM.0b013e3182783b72.

  PMID: 23269131 BACKGROUND

• Bergeron N, Dubois MJ, Dumont M, Dial S, Skrobik Y. Intensive Care Delirium Screening Checklist: evaluation of a new screening tool. Intensive Care Med. 2001 May;27(5):859-64. doi: 10.1007/s001340100909.

  PMID: 11430542 BACKGROUND

• Brummel NE, Girard TD. Preventing delirium in the intensive care unit. Crit Care Clin. 2013 Jan;29(1):51-65. doi: 10.1016/j.ccc.2012.10.007.

  PMID: 23182527 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

• Gelinas C, Fillion L, Puntillo KA, Viens C, Fortier M. Validation of the critical-care pain observation tool in adult patients. Am J Crit Care. 2006 Jul;15(4):420-7.

  PMID: 16823021 BACKGROUND

• Kamdar BB, King LM, Collop NA, Sakamuri S, Colantuoni E, Neufeld KJ, Bienvenu OJ, Rowden AM, Touradji P, Brower RG, Needham DM. The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU. Crit Care Med. 2013 Mar;41(3):800-9. doi: 10.1097/CCM.0b013e3182746442.

  PMID: 23314584 BACKGROUND

• Morandi A, Brummel NE, Ely EW. Sedation, delirium and mechanical ventilation: the 'ABCDE' approach. Curr Opin Crit Care. 2011 Feb;17(1):43-9. doi: 10.1097/MCC.0b013e3283427243.

  PMID: 21169829 BACKGROUND

• Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.

  PMID: 18596631 BACKGROUND

• Naidech AM, Beaumont JL, Rosenberg NF, Maas MB, Kosteva AR, Ault ML, Cella D, Ely EW. Intracerebral hemorrhage and delirium symptoms. Length of stay, function, and quality of life in a 114-patient cohort. Am J Respir Crit Care Med. 2013 Dec 1;188(11):1331-7. doi: 10.1164/rccm.201307-1256OC.

  PMID: 24102675 BACKGROUND

• Olson DM, Borel CO, Laskowitz DT, Moore DT, McConnell ES. Quiet time: a nursing intervention to promote sleep in neurocritical care units. Am J Crit Care. 2001 Mar;10(2):74-8.

  PMID: 11244674 BACKGROUND

• Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.

  PMID: 19446324 BACKGROUND

• Svenningsen H, Tonnesen E. Delirium incidents in three Danish intensive care units. Nurs Crit Care. 2011 Jul-Aug;16(4):186-92. doi: 10.1111/j.1478-5153.2011.00421.x.

  PMID: 21651659 BACKGROUND

• Yu A, Teitelbaum J, Scott J, Gesin G, Russell B, Huynh T, Skrobik Y. Evaluating pain, sedation, and delirium in the neurologically critically ill-feasibility and reliability of standardized tools: a multi-institutional study. Crit Care Med. 2013 Aug;41(8):2002-7. doi: 10.1097/CCM.0b013e31828e96c0.

  PMID: 23863231 BACKGROUND

• Larsen LK, Frokjaer VG, Nielsen JS, Skrobik Y, Winkler Y, Moller K, Petersen M, Egerod I. Delirium assessment in neuro-critically ill patients: A validation study. Acta Anaesthesiol Scand. 2019 Mar;63(3):352-359. doi: 10.1111/aas.13270. Epub 2018 Oct 16.

  PMID: 30324653 DERIVED

MeSH Terms

Conditions

Delirium; Brain Injuries

Interventions

Sleep

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kirsten moeller, professor

  Rigshospitalet, 2093

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, dept. of Neuroanaesthesiology

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: November 3, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: October 4, 2017

Record last verified: 2016-10

Locations

DK (1)