BMJ Open (Apr 2024)

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

  • ,
  • Jean-François Timsit,
  • Damien Contou,
  • Julien Schmidt,
  • Carine Roy,
  • Romain Sonneville,
  • Lila Bouadma,
  • Armand Mekontso Dessap,
  • Michel Djibré,
  • Camille Couffignal,
  • Juliette Audibert,
  • Pierre Jaquet,
  • Virginie Godard,
  • Romane Bellot,
  • Fariza Lamara,
  • Tchoubou Tona,
  • Florian Sigaud,
  • Adam Celier,
  • Claire Bourel,
  • Fatiha Essardy,
  • Renaud Cornic,
  • ABGRALL Gwenole,
  • ARRESTIER Romain,
  • AUDIBERT Juliette,
  • AUGY Jean loup,
  • BAGATE François,
  • BAY Pierre,
  • BEGOT Erwan,
  • BEN SALAH Adel,
  • BENELLI Brice,
  • BERTI Enora,
  • BERTIER Astrid,
  • BEURTON Alexandra,
  • BILLIET Pierre-Antoine,
  • BOUADMA Lila,
  • BOUGNAUD Joanna,
  • BOUILLAND Anne Laure,
  • BOUJELBEN Mohamed,
  • BUREAU Côme,
  • CANDILLE Clara,
  • CARIOU Erwann,
  • CARTEAUX Guillaume,
  • CATANO Jenifer,
  • CAVALEIRO Pedro,
  • CELIER Adam,
  • CHAFIOTTE Pierre,
  • CIRILLO Giulia,
  • CLERC Sébastien,
  • CONIA Alexandre,
  • CORDIER Charlotte,
  • COUPRY Louis-Marie,
  • DA SILVA Daniel,
  • DARTEVEL Anais,
  • DE MONTMOLLIN Etienne,
  • DE MONTMOLLIN Nina,
  • DE PROST Nicolas,
  • DECAVELE Maxens,
  • DELERIS Robin,
  • DEMOULE Alexandre,
  • DESNOS Cyrielle,
  • DESSAJAN Julien,
  • DIEMOZ Marie-Claire,
  • DO REGO Hermann,
  • DO VALE Julien,
  • DRES Martin,
  • DUFRANC Etienne,
  • EJZENBERG Michael,
  • ELABBADI Alexandre,
  • FLOCH Pierre Edouard,
  • FOSSE Quentin,
  • FRAPARD Thomas,
  • GAILLET Antoine,
  • GALERNEAU Louis-Marie,
  • GENDREAU Ségolène,
  • GONCALVES CAVALEIRO Pedro,
  • GONTIER Olivier,
  • HAMROUNI Mouldi,
  • HAUDEBOURG Anne-Fleur,
  • HAUDEBOURG Luc,
  • JOLLY Florian,
  • LA MAREC Julien,
  • LABEDADE Pascale,
  • LAVILLEGRAND Jean-Rémi,
  • LECRONIER Marie,
  • LOPINTO Julien,
  • MASI Paul,
  • MAYAUX Julien,
  • MENAT Sophie,
  • MONCOMBLE Elsa,
  • MORAWIEC Elise,
  • NAGLE Sophie,
  • NEMLAGHI Safaa,
  • PICARD Benjamin,
  • PICHON Jeremie,
  • PLAIS Henri,
  • RAZAZI Keyvan,
  • RIGAULT Guillaume,
  • SIGAUD Florian,
  • SONNEVILLE Romain,
  • THY Michael,
  • TIMSIT Jean-François,
  • TUFFET Samuel,
  • TURPIN Matthieu,
  • VINCENT Xavier,
  • VOIRIOT Guillaume,
  • WICKY Paul-Henri,
  • WINDSOR Camille

DOI
https://doi.org/10.1136/bmjopen-2023-083414
Journal volume & issue
Vol. 14, no. 4

Abstract

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Introduction 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.Methods and analysis 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.Ethics and dissemination 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.Trial registration number NCT04273360.