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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.
To explore and summarise the literature on the concept of ‘clinical deterioration’ as a nurse-sensitive indicator of quality of care in the out-of-hospital context.
The scoping review adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Review and the JBI best practice guidelines for scoping reviews.
Studies focusing on clinical deterioration, errors of omission, nurse sensitive indicators and the quality of nursing and midwifery care for all categories of registered, enrolled, or licensed practice nurses and midwives in the out-of-hospital context were included regardless of methodology. Text and opinion papers were also considered. Study protocols were excluded.
Data bases were searched from inception to June 2022 and included CINAHL, PsychINFO, MEDLINE, The Allied and Complementary Medicine Database, EmCare, Maternity and Infant Care Database, Australian Indigenous HealthInfoNet, Informit Health and Society Database, JSTOR, Nursing and Allied Health Database, RURAL, Cochrane Library and Joanna Briggs Institute.
Thirty-four studies were included. Workloads, education and training opportunities, access to technology, home visits, clinical assessments and use of screening tools or guidelines impacted the ability to recognise, relay information and respond to clinical deterioration in the out-of-hospital setting.
Little is known about the work of nurses or midwives in out-of-hospital settings and their recognition, reaction to and relay of information about patient deterioration. The complex and subtle nature of non-acute deterioration creates challenges in defining and subsequently evaluating the role and impact of nurses in these settings.
Further research is needed to clarify outcome measures and nurse contribution to the care of the deteriorating patient in the out-of-hospital setting to reduce the rate of avoidable hospitalisation and articulate the contribution of nurses and midwives to patient care.
Factors that impact a nurse's ability to recognise, relay information and respond to clinical deterioration in the out-of-hospital setting are not examined to date.
A range of factors were identified that impacted a nurse's ability to recognise, relay information and respond to clinical deterioration in the out-of-hospital setting including workloads, education and training opportunities, access to technology, home visits, clinical assessments, use of screening tools or guidelines, and avoidable hospitalisation.
Where and on whom will the research have an impact?
Nurses and nursing management will benefit from understanding the factors that act as barriers and facilitators for effective recognition of, and responding to, a deteriorating patient in the out-of-hospital setting. This in turn will impact patient survival and satisfaction.
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Review guidelines guided this review. The PRISMA-Scr Checklist (Tricco et al., 2018) is included as (supplementary file 1).Data sharing is not applicable to this article as no new data were created or analysed in this study.”
Not required as the Scoping Review used publicly available information.
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