DeliriumDELIREANCT03125252
Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units
A study testing Bundle and Standard Paramedical and Medical practices in people with Delirium, run by University Hospital, Toulouse at 14 sites in France.
Trial summary
The main objective is to evaluate the impact of the "bundle of actions" on the delirium's incidence in resuscitation patients during their stay in the service, compared to a conventional treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Delirium
- What is being tested?
- Bundle and Standard Paramedical and Medical practices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 14 sitesFrance
- Study dates
- 27 Oct 2016to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed by the trusted person and the patient upon waking
- Hospitalized in reanimation service (first hospitalization or transfer of another service)
- 48 hours of sedation with intubation during hospitalization (all combinations of morphine, hypnotics, sedatives, anesthetics, narcoleptics)
- Francophone (able to understand all evaluations)
- Criteria for the inclusion of 50 delirium positive patients drawn from the Toulouse center (participating in the neuropsychological evaluation): In addition to those mentioned above:
- Absence of pre-existing cognitive impairment (patients whose relative has completed the IQCode questionnaire and whose score is <3.4 points)
- Visual, auditory (authorized equipment) skills and adequate oral or written expression for the proper conduct of neuropsychological tests.
Who cannot join
- Pregnant women
- Evolutive neurological disease leading to cognitive impairment (multiple sclerosis, Parkinson's disease, Alzheimer's disease), and / or focal neurological disease leading to cognitive impairment (head trauma, stroke, ...)
- Evolving psychiatric illness (including severe depression)
- Voluntary drug poisoning
- Patients who have already participated in the study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Saint-André Hospital
Bordeaux, 33000
Hospital Castres-Mazamet
Castres, 81
Estaing Hospital
Clermont-Ferrand, 63100
Gabriel Montpied
Clermont-Ferrand, 63100
Nord Hospital
Marseille, 13015
Saint-Joseph Hospital
Marseille, 13285
Montauban Hospital
Montauban, 82000
Hospital
Montpellier, 34090
Caremeau Hospital
Nîmes, 30929
Perpignan Hospital
Perpignan, 66046
Jacques Puel Hospital
Rodez, 12027
University Hospital Toulouse
Toulouse, 31000
Oncologic Hospital
Toulouse, 31059
Rangueil Hospital
Toulouse, 31059
About this study
The main objective is to evaluate the impact of the "bundle of actions" on the delirium's incidence in resuscitation patients during their stay in the service, compared to a conventional treatment.
The investigators therefore hypothesize that a set of coordinated paramedical actions in the prevention of delirium would reduce its incidence by 15% compared to conventional care.
Read the detailed description
The "Bundle of Actions" is a coordinated and specific action plan, which has already been validated, focusing on the coordination of wake-up and respiration, the management of delirium, as well as the early mobility of the patient. Innovation consists of simple, reproducible nursing care that reduces triggers of delirium; as well as the use of two new approaches in reanimation: conversational hypnosis and early and comprehensive re-empowerment of the patient in the management of his pain and well-being.
- Conditions
- Delirium
- Being tested
- Bundle, Standard Paramedical and Medical practices
- Keywords
- Delirium, Reanimation, Conversational hypnosis
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BundleOther
Also called ABCDE
Awakening and Breathing Coordination Delirium monitoring and management (detection and management of delirium) Early mobility
Factors of environment:
- thirst
- noise
- pain and well-being
- sleep
- isolation
Standard Paramedical and Medical practicesOther
The current recommendations recommend the following scheme:
- Identification and correction of an organic cause / factors (sepsis, metabolic disorders, withdrawal syndrome, pain)
- Use of non-pharmacological means (early mobilization, correction of sensory deficits, temporo-spatial reorientation strategies)
- Use of reference antipsychotic pharmacological means
| Study group | Role | What they receive |
|---|---|---|
| Bundle | Experimental | Specific action plan : ABCDE, complemented with care related to the nursing and paramedical role concerning the patient's environmental factors Receives: Other: Bundle |
| Control | Other | Standard paramedical and medical practices Receives: Other: Standard Paramedical and Medical practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of delirium
CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.
Measured: Day 60
Secondary outcomes (3)
Duration of the delirium between the diagnosis and the resolution of the delirium
The duration of the delirium (in days) between the diagnosis and the resolution of the delirium will be done until 60 days of the stay of the patients in intensive care.
Measured: Day 60
Evaluation of cognitive and psycho-behavioral functions.
Cognitive and psycho-behavioral functions are usually evaluated by a corpus of test :
- memory : Test of 5 words and Free Recall Test
- executive : Fast Evaluation Battery for Executive Functions, Trail Making Test, Digit Span, Stroop and Verbal Fluences and Animals
- praxis : Mahieux's Test
- language : D0 80
- behavior : Montgomery's scale (depression), Starkstein's scale (apathy).
Measured: Day 60 and month 3
Quality of life at one year
The evaluation of 142 first patients delirium positive: the first 12 patients delirium positive in the 6 centers of the arm to which Toulouse will not belong, and the first 14 patients delirium positive in the 5 centers of the arm to which Toulouse will belong (Toulouse excluded), 1 year after the date of their inclusion in the study during their hospitalization in reanimation service.
This evaluation of Quality of life of the first patients detected positive to delirium will be carried out using the validated French standardized questionnaire or Short Form 36 item (SF-36) which will be sent by post to the patient's home.
Measured: Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start27 Oct 2016
- Primary completionApr 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fanny CROZES, nurse, Study director, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125252
- Sponsor's protocol ID
- 15 7842 16
- Acronym
- DELIREA
- Status last verified
- Nov 2020
- First submitted
- 5 Mar 2017
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aissaoui Y, Zeggwagh AA, Zekraoui A, Abidi K, Abouqal R. Validation of a behavioral pain scale in critically ill, sedated, and mechanically ventilated patients. Anesth Analg. 2005 Nov;101(5):1470-1476. doi: 10.1213/01.ANE.0000182331.68722.FF.
PubMed 16244013Arend E, Christensen M. Delirium in the intensive care unit: a review. Nurs Crit Care. 2009 May-Jun;14(3):145-54. doi: 10.1111/j.1478-5153.2008.00324.x.
PubMed 19366412Balas MC, Vasilevskis EE, Burke WJ, Boehm L, Pun BT, Olsen KM, Peitz GJ, Ely EW. Critical care nurses' role in implementing the "ABCDE bundle" into practice. Crit Care Nurse. 2012 Apr;32(2):35-8, 40-7; quiz 48. doi: 10.4037/ccn2012229.
PubMed 22467611Chanques G, Payen JF, Mercier G, de Lattre S, Viel E, Jung B, Cisse M, Lefrant JY, Jaber S. Assessing pain in non-intubated critically ill patients unable to self report: an adaptation of the Behavioral Pain Scale. Intensive Care Med. 2009 Dec;35(12):2060-7. doi: 10.1007/s00134-009-1590-5.
PubMed 19697008Devlin JW, Brummel NE, Al-Qadheeb NS. Optimising the recognition of delirium in the intensive care unit. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):385-93. doi: 10.1016/j.bpa.2012.08.002.
PubMed 23040288Ely 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.
PubMed 15082703Erickson MH, Rossi EL. Two level communication and the microdynamics of trance and suggestion. Am J Clin Hypn. 1976 Jan;18(3):153-71. doi: 10.1080/00029157.1976.10403794. No abstract available.
PubMed 1246970Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.
PubMed 18495054Guenther U, Popp J, Koecher L, Muders T, Wrigge H, Ely EW, Putensen C. Validity and reliability of the CAM-ICU Flowsheet to diagnose delirium in surgical ICU patients. J Crit Care. 2010 Mar;25(1):144-51. doi: 10.1016/j.jcrc.2009.08.005. Epub 2009 Oct 13.
PubMed 19828283McCusker J, Cole MG, Voyer P, Monette J, Champoux N, Ciampi A, Vu M, Belzile E. Six-month outcomes of co-occurring delirium, depression, and dementia in long-term care. J Am Geriatr Soc. 2014 Dec;62(12):2296-302. doi: 10.1111/jgs.13159. Epub 2014 Dec 8.
PubMed 25482152Crozes F, Seailles S, Planton M, Lepage M, Quintard M, Huo Yung Kai S, Silva S, Haubertin C. Impact des mesures preventives non pharmacologiques sur l'incidence du delirium chez les adultes en reanimation : protocole d'etude d'un essai controle randomise en cluster. Rech Soins Infirm. 2026;164(1):57-70. doi: 10.3917/rsi.164.0057. French.
PubMed 42686628
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-pharmacological Prevention Measures on the Incidence of Delirium in Adult Intensive Care Units
- ClinicalTrials.gov ID
- NCT03125252
- Acronym / sponsor ID
- DELIREA / 15 7842 16
- Conditions
- Delirium
- Keywords
- Delirium, Reanimation, Conversational hypnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to evaluate the impact of the "bundle of actions" on the delirium's incidence in resuscitation patients during their stay in the service, compared to a conventional treatment.
The investigators therefore hypothesize that a set of coordinated paramedical actions in the prevention of delirium would reduce its incidence by 15% compared to conventional care.
Detailed description
The "Bundle of Actions" is a coordinated and specific action plan, which has already been validated, focusing on the coordination of wake-up and respiration, the management of delirium, as well as the early mobility of the patient. Innovation consists of simple, reproducible nursing care that reduces triggers of delirium; as well as the use of two new approaches in reanimation: conversational hypnosis and early and comprehensive re-empowerment of the patient in the management of his pain and well-being.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bundle | Experimental | Other: BundleSpecific action plan : ABCDE, complemented with care related to the nursing and paramedical role concerning the patient's environmental factors |
| Control | Other | Other: Standard Paramedical and Medical practicesStandard paramedical and medical practices |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent signed by the trusted person and the patient upon waking
- Hospitalized in reanimation service (first hospitalization or transfer of another service)
- 48 hours of sedation with intubation during hospitalization (all combinations of morphine, hypnotics, sedatives, anesthetics, narcoleptics)
- Francophone (able to understand all evaluations)
- Criteria for the inclusion of 50 delirium positive patients drawn from the Toulouse center (participating in the neuropsychological evaluation): In addition to those mentioned above:
Key exclusion criteria (5 listed)
- Pregnant women
- Evolutive neurological disease leading to cognitive impairment (multiple sclerosis, Parkinson's disease, Alzheimer's disease), and / or focal neurological disease leading to cognitive impairment (head trauma, stroke, ...)
- Evolving psychiatric illness (including severe depression)
- Voluntary drug poisoning
- Patients who have already participated in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BundleAlso: ABCDEAwakening and Breathing Coordination Delirium monitoring and management (detection and management of delirium) Early mobility Factors of environment: * thirst * noise * pain and well-being * sleep * isolation | Other | Bundle |
| Standard Paramedical and Medical practicesThe current recommendations recommend the following scheme: * Identification and correction of an organic cause / factors (sepsis, metabolic disorders, withdrawal syndrome, pain) * Use of non-pharmacological means (early mobilization, correction of sensory deficits, temporo-spatial reorientation strategies) * Use of reference antipsychotic pharmacological means | Other | Control |
Primary outcome
Incidence rate of delirium
Time frame: Day 60
CAM-ICU Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale.
3 secondary outcomes
Duration of the delirium between the diagnosis and the resolution of the delirium
Time frame: Day 60
Evaluation of cognitive and psycho-behavioral functions.
Time frame: Day 60 and month 3
Quality of life at one year
Time frame: Year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Background: PubMed 16244013Aissaoui Y, Zeggwagh AA, Zekraoui A, Abidi K, Abouqal R. Validation of a behavioral pain scale in critically ill, sedated, and mechanically ventilated patients. Anesth Analg. 2005 Nov;101(5):1470-1476. doi: 10.1213/01.ANE.0000182331.68722.FF.
- Background: PubMed 19366412Arend E, Christensen M. Delirium in the intensive care unit: a review. Nurs Crit Care. 2009 May-Jun;14(3):145-54. doi: 10.1111/j.1478-5153.2008.00324.x.
- Background: PubMed 22467611Balas MC, Vasilevskis EE, Burke WJ, Boehm L, Pun BT, Olsen KM, Peitz GJ, Ely EW. Critical care nurses' role in implementing the "ABCDE bundle" into practice. Crit Care Nurse. 2012 Apr;32(2):35-8, 40-7; quiz 48. doi: 10.4037/ccn2012229.
- Background: PubMed 19697008Chanques G, Payen JF, Mercier G, de Lattre S, Viel E, Jung B, Cisse M, Lefrant JY, Jaber S. Assessing pain in non-intubated critically ill patients unable to self report: an adaptation of the Behavioral Pain Scale. Intensive Care Med. 2009 Dec;35(12):2060-7. doi: 10.1007/s00134-009-1590-5.
- Background: PubMed 23040288Devlin JW, Brummel NE, Al-Qadheeb NS. Optimising the recognition of delirium in the intensive care unit. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):385-93. doi: 10.1016/j.bpa.2012.08.002.
- Background: PubMed 15082703Ely 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.
- Background: PubMed 1246970Erickson MH, Rossi EL. Two level communication and the microdynamics of trance and suggestion. Am J Clin Hypn. 1976 Jan;18(3):153-71. doi: 10.1080/00029157.1976.10403794. No abstract available.
- Background: PubMed 18495054Girard TD, Pandharipande PP, Ely EW. Delirium in the intensive care unit. Crit Care. 2008;12 Suppl 3(Suppl 3):S3. doi: 10.1186/cc6149. Epub 2008 May 14.
- Background: PubMed 19828283Guenther U, Popp J, Koecher L, Muders T, Wrigge H, Ely EW, Putensen C. Validity and reliability of the CAM-ICU Flowsheet to diagnose delirium in surgical ICU patients. J Crit Care. 2010 Mar;25(1):144-51. doi: 10.1016/j.jcrc.2009.08.005. Epub 2009 Oct 13.
- Background: PubMed 25482152McCusker J, Cole MG, Voyer P, Monette J, Champoux N, Ciampi A, Vu M, Belzile E. Six-month outcomes of co-occurring delirium, depression, and dementia in long-term care. J Am Geriatr Soc. 2014 Dec;62(12):2296-302. doi: 10.1111/jgs.13159. Epub 2014 Dec 8.
- Derived from this study: PubMed 42686628Crozes F, Seailles S, Planton M, Lepage M, Quintard M, Huo Yung Kai S, Silva S, Haubertin C. Impact des mesures preventives non pharmacologiques sur l'incidence du delirium chez les adultes en reanimation : protocole d'etude d'un essai controle randomise en cluster. Rech Soins Infirm. 2026;164(1):57-70. doi: 10.3917/rsi.164.0057. French.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fanny CROZES, nurse study director
University Hospital, Toulouse
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bundle and Standard Paramedical and Medical practices in people with Delirium, run by University Hospital, Toulouse at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of delirium (time frame: Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03125252, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.