Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04273360 |
Other study ID # |
APHP190776 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 25, 2021 |
Est. completion date |
December 2024 |
Study information
Verified date |
March 2024 |
Source |
Assistance Publique - Hôpitaux de Paris |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The R2D2-ICU study will be a prospective, parallel-group, open label, multicenter (6 centers)
randomized controlled trial. All consecutive eligible patients will be included. Patients
will be randomly assigned (1/1 ratio) to either systematic PR use (systematic use group) or
restrictive PR use (restrictive use group). Patients in the restrictive PR group will be
subjected to PR only in case of severe agitation defined by a RASS ≥ +3. Physical restraint
will consist of wrist straps. In both groups, patients will receive standardized management
for analgesia, sedation, delirium detection, weaning and early mobilization according to
current guidelines. Concealment will be obtained using a computer-generated randomization
scheme of various-sized blocks stratified by center, age (< or ≥ 65 years) and coma at the
beginning of invasive mechanical ventilation (D0)) through a centralized 24h/24h internet
service. Investigation blinded to group assignment is not feasible. In both arms, patients'
arousal will be evaluated twice a day until day 14 with the use of RASS. Patients with a RASS
of -5 or -4 will be considered comatose (and will not be assessed for delirium). Patients
with a RASS score ≥ -3 will be assessed for delirium with the use of the CAM-ICU scale twice
a day.
Description:
Physical restraint (PR) is defined by the HAS (Haute Autorité de Santé française) as the use
of any intervention that prevent or limit movements capability, to protect a person from an
inappropriate or a dangerous behavior. In French intensive care units (ICUs), wrist straps
(and sometimes ankle straps) are frequently used to prevent self-removal of medical devices
in case of agitation, which can affect about 50% of patients. A survey conducted in 121
French ICUs showed that in 82 % of ICUs, PR is used at least once during mechanical
ventilation (MV) in more than 50 % of patients. In 65 % of ICUs, when PR is used, it is
applied for more than 50 % of MV duration. In 29 % of ICUs, PR is used in more than 50 % of
cases in awake, calm and co-operative patients. PR is started without written medical
prescription in more than 50 % of patients in 68 % of ICUs. Only 21 % of ICUs have a written
local procedure for PR use. In the European PRICE study (566 patients, 34 ICUs, 9 countries),
the frequency of PR use varied from 0% to 100%.
The benefit of PR is not clearly established and PR could also be deleterious in this
context. First, PR may leave patients with moderate to extremely stressful memory. Second,
there is no demonstrated relationship between the PR rates and self-removal of medical
devices. Finally, there is a complex relationship between agitation, PR use and delirium.
While PR is prescribed to avoid potential risks associated with agitation, it seems to favor
delirium. Delirium is a serious event in ICU patients that is independently associated with
adverse outcomes in patients receiving MV. Moreover, the number of days of ICU delirium is
significantly associated with increased 1-year mortality and long-term cognitive impairment
in survivors.
The R2D2-ICU study will be a prospective, parallel-group, open label, multicenter (6 centers)
randomized controlled trial. All consecutive eligible patients will be included. Patients
will be randomly assigned (1/1 ratio) to either systematic PR use (systematic use group) or
restrictive PR use (restrictive use group). Patients in the restrictive PR group will be
subjected to PR only in case of severe agitation defined by a RASS ≥ +3. Physical restraint
will consist of wrist straps. In both groups, patients will receive standardized management
for analgesia, sedation, delirium detection, weaning and early mobilization according to
current guidelines. Concealment will be obtained using a computer-generated randomization
scheme of various-sized blocks stratified by center, age (< or ≥ 65 years) and coma at the
beginning of invasive mechanical ventilation (D0)) through a centralized 24h/24h internet
service. Investigation blinded to group assignment is not feasible. In both arms, patients'
arousal will be evaluated twice a day until day 14 with the use of RASS. Patients with a RASS
of -5 or -4 will be considered comatose (and will not be assessed for delirium). Patients
with a RASS score ≥ -3 will be assessed for delirium with the use of the CAM-ICU scale twice
a day.