Restrictive use of Restraints and Delirium Duration in the Intensive Care Unit (R2D2-ICU): protocol for a French multicentre parallel-group open-label randomised controlled trial.
Delirium & cognitive disorders
INTENSIVE & CRITICAL CARE
Patient Reported Outcome Measures
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
17 Apr 2024
17 Apr 2024
Historique:
medline:
19
4
2024
pubmed:
18
4
2024
entrez:
17
4
2024
Statut:
epublish
Résumé
Physical restraint (PR) is prescribed in patients receiving invasive mechanical ventilation in the intensive care unit (ICU) to avoid unplanned removal of medical devices. However, it is associated with an increased risk of delirium. We hypothesise that a restrictive use of PR, as compared with a systematic use, could reduce the duration of delirium in ICU patients receiving invasive mechanical ventilation. The Restrictive use of Restraints and Delirium Duration in ICU (R2D2-ICU) study is a national multicentric, parallel-group, randomised (1:1) open-label, controlled, superiority trial, which will be conducted in 10 ICUs. A total of 422 adult patients requiring invasive mechanical ventilation for an expected duration of at least 48 hours and eligible for prescription of PR will be randomly allocated within 6 hours from intubation to either the restrictive PR use group or the systematic PR use group, until day 14, ICU discharge or death, whichever comes first. In both groups, PR will consist of the use of wrist straps. The primary endpoint will be delirium or coma-free days, defined as the number of days spent alive in the ICU without coma or delirium within the first 14 days after randomisation. Delirium will be assessed using the Confusion Assessment Method-ICU twice daily. Key secondary endpoints will encompass agitation episodes, opioid, propofol, benzodiazepine and antipsychotic drug exposure during the 14-day intervention period, along with a core outcome set of measures evaluated 90 days postrandomisation. The R2D2-ICU study has been approved by the Comité de Protection des Personnes (CPP) ILE DE FRANCE III-PARIS (CPP19.09.06.37521) on June 10th, 2019). Participant recruitment started on 25 January 2021. Results will be published in international peer-reviewed medical journals and presented at conferences. NCT04273360.
Identifiants
pubmed: 38631841
pii: bmjopen-2023-083414
doi: 10.1136/bmjopen-2023-083414
doi:
Substances chimiques
Propofol
YI7VU623SF
Antipsychotic Agents
0
Banques de données
ClinicalTrials.gov
['NCT04273360']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e083414Investigateurs
Abgrall Gwenole
(A)
Arrestier Romain
(A)
Audibert Juliette
(A)
Augy Jean Loup
(AJ)
Bagate François
(B)
Bay Pierre
(B)
Begot Erwan
(B)
Ben Salah Adel
(B)
Benelli Brice
(B)
Berti Enora
(B)
Bertier Astrid
(B)
Beurton Alexandra
(B)
Billiet Pierre-Antoine
(B)
Bouadma Lila
(B)
Bougnaud Joanna
(B)
Bouilland Anne Laure
(BA)
Boujelben Mohamed
(B)
Bureau Côme
(B)
Candille Clara
(C)
Cariou Erwann
(C)
Carteaux Guillaume
(C)
Catano Jenifer
(C)
Cavaleiro Pedro
(C)
Celier Adam
(C)
Chafiotte Pierre
(C)
Cirillo Giulia
(C)
Clerc Sébastien
(C)
Conia Alexandre
(C)
Cordier Charlotte
(C)
Coupry Louis-Marie
(C)
D A Silva Daniel
(DA)
Dartevel Anais
(D)
D E Montmollin Etienne
(DE)
D E Montmollin Nina
(DE)
D E Prost Nicolas
(DE)
Decavele Maxens
(D)
Deleris Robin
(D)
Demoule Alexandre
(D)
Desnos Cyrielle
(D)
Dessajan Julien
(D)
Diemoz Marie-Claire
(D)
D O Rego Hermann
(DO)
D O Vale Julien
(DO)
Dres Martin
(D)
Dufranc Etienne
(D)
Ejzenberg Michael
(E)
Elabbadi Alexandre
(E)
Floch Pierre Edouard
(FP)
Fosse Quentin
(F)
Frapard Thomas
(F)
Gaillet Antoine
(G)
Galerneau Louis-Marie
(G)
Gendreau Ségolène
(G)
Goncalves Cavaleiro Pedro
(GC)
Gontier Olivier
(G)
Hamrouni Mouldi
(H)
Haudebourg Anne-Fleur
(H)
Haudebourg Luc
(H)
Jolly Florian
(J)
L A Marec Julien
(LA)
Labedade Pascale
(L)
Lavillegrand Jean-Rémi
(L)
Lecronier Marie
(L)
Lopinto Julien
(L)
Masi Paul
(M)
Mayaux Julien
(M)
Menat Sophie
(M)
Moncomble Elsa
(M)
Morawiec Elise
(M)
Nagle Sophie
(N)
Nemlaghi Safaa
(N)
Picard Benjamin
(P)
Pichon Jeremie
(P)
Plais Henri
(P)
Razazi Keyvan
(R)
Rigault Guillaume
(R)
Sigaud Florian
(S)
Sonneville Romain
(S)
Tchoubou Tona
(T)
Thy Michael
(T)
Timsit Jean-François
(T)
Tuffet Samuel
(T)
Turpin Matthieu
(T)
Vincent Xavier
(V)
Voiriot Guillaume
(V)
Wicky Paul-Henri
(W)
Windsor Camille
(W)
Informations de copyright
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
Déclaration de conflit d'intérêts
Competing interests: RS received grants from the French Ministry of Health and from LB.
Références
Intensive Crit Care Nurs. 2010 Oct;26(5):241-5
pubmed: 20837320
Crit Care Med. 2013 Jan;41(1):263-306
pubmed: 23269131
Intensive Care Med. 2017 Sep;43(9):1329-1339
pubmed: 28612089
JAMA. 2001 Dec 5;286(21):2703-10
pubmed: 11730446
Crit Care Med. 2013 Feb;41(2):405-13
pubmed: 23263581
Am J Respir Crit Care Med. 2009 Dec 1;180(11):1092-7
pubmed: 19745202
Am J Respir Crit Care Med. 2011 Aug 1;184(3):340-4
pubmed: 21562131
JAMA. 2009 Feb 4;301(5):489-99
pubmed: 19188334
Crit Care Med. 2001 Jul;29(7):1370-9
pubmed: 11445689
Crit Care Med. 2018 Sep;46(9):1532-1548
pubmed: 30113371
J Intensive Care Med. 2019 Apr;34(4):330-336
pubmed: 28335673
Crit Care Med. 2001 Dec;29(12):2258-63
pubmed: 11801819
PLoS Med. 2007 Oct 16;4(10):e297
pubmed: 17941715
Chest. 2005 Oct;128(4):2749-57
pubmed: 16236951
Intensive Care Med. 2013 Jan;39(1):31-7
pubmed: 23064500
Stat Med. 2014 Feb 20;33(4):693-713
pubmed: 24105821
N Engl J Med. 2013 Oct 3;369(14):1306-16
pubmed: 24088092
Am J Crit Care. 2015 Nov;24(6):488-95
pubmed: 26523006
Crit Care Med. 2002 Apr;30(4):746-52
pubmed: 11940739
Crit Care Med. 2015 Mar;43(3):557-66
pubmed: 25493968
JAMA. 2007 Dec 12;298(22):2644-53
pubmed: 18073360
Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44
pubmed: 12421743
Crit Care. 2014 Mar 24;18(2):R46
pubmed: 24661688
Syst Rev. 2016 Nov 21;5(1):194
pubmed: 27871314