Delirium of Mixed Origin Clinical Trial
Official title:
Trial Randomized, Double-blind, Controlled of Delirium Prevention Program in Patients From the Intensive Care Unit Los Comuneros Hospital University of Bucaramanga, Colombia
"To determine the efficacy of program of prevention of delirium in critically ill patients from the intensive care units of Bucaramanga and Floridablanca. Methods: The study will be a randomized controlled clinical trial in 600 critically ill patients recruited at 24 hours from arrival on the intensive care units of Bucaramanga and Floridablanca, without delirium, with ≥50% in the PREDELIRIC scale score, who comply with the inclusion and exclusion. The patients will be randomized in blocks to one of the two groups, intervention group (delirium prevention program, n=200) with control group (usual care; n= 400), the study will compare the incidence of delirium in both groups. Patients will be followed every day with Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) until the patient presents delirium, exit to hospitalization or death. Delirium prevention program includes individualized nonpharmacological interventions such as multisensory stimulation, cognitive stimulation, activate the functional and family involvement. The study has received ethical approval from the University of Santander"
"delirium predominance in the intensive care unit (ICU) is 20- 80%, depending on the scale to
which it measures itself and some characteristics of the patients ( Carrillo & Sosa, 2010).
The development of the delirium in the intensive care unit presents an important impact in
the treatment of the patient , therefore directly influences the hospital cost , in the stay
and the mortality .Martinez & others (2004) also , the delirium is diagnosed just in 66-84%
of the patients who present this complication , because in come circumstances it is confused
with dementia or anxiety and why there does not exist a diagnostic methodology adequate for
its evaluation. With regard to the diagnosis of the delirium , several methods exist for the
diagnosis , the evaluation method of the confusion CAMICU of the english confusion assesment
method for the ICU is the most used, in the intensive care unit , for its high sensibility,
reliability and validity to identify delirium when it is used by nurses and doctors of the
ICU and only it needs 2-3 minutes for its achievement (Ely & others, 2004) This way, Boogaard
and collaborators decided to construct and validate a model who allows to predict the
delirium probability in adult patients of intensive care unit (Boogaard
- others, 2012), in order to restore preventive measurements to reduce its incidence,
gravity and duration. The delirium have high frequency and with an impact
bio-psico-economic in the patient and its environment , the prevention is the most
effective and economic measure of tackling the delirium in its initial phase and nursing
contributes to a great extent in this work . It is as well as in a titled previous study
: validity of the model of prediction of the delirium in intensive care unit of
Bucaramanga, realized by Torres and Páez in 2014 in the Comuneros universitarian
Hospital of Bucaramanga brought up to the date an incidence of the delirium of 20.5%,
with a mortality of 47.5% of the patients who do delirium during its stay in ICU ,
proving the efficacy od the model PREDELIRIC to predict the delirium in the first 24
hours of stay in ICU , in patients with high values its like say a PREDELIRIC result
>50% Taking this study as a precedent there appears the target to determine the efficacy
of the prevention program of delirium in the population of critical patients in
Bucaramanga, (the Comuneros universitarian Hospital of Bucaramanga) across a randomized
controlled clinical essay , in order to predict early in these patients the possibility
of delirium development and to facilitate the application of preventive measurements not
pharmacological in patients with high risk . these preventive measurements would be done
across individualized interventions and they would be focused after the improved
orientation , cognitive stimulation , early mobilization to listen to music with the
intention of reduce the delirium incidence, of improving the cognition of the patients
and avoiding its deterioration during the staying in the ICU , condition that can remain
after its departure ( Inouye & others, 1999). Also, the results of this investigation
will appear in a scientific article and scientific congresses in the área of health .
Also, they will be announced to the universitarian community and the involved
institution. Key words : Delirium, intensive care, prevention , nursing interventions.
Like an important antecedent in Santander the group of research of the nursing program
Everest execute a study to validate the prediction model PREDELIRIC to a spanish version
, this study expose the need to identify and implement interventions of nursing to
prevent the delirium in critical patients of Bucaramanga Our priority now is to apply
the model of prediction PREDELIRIC validated in a spanish version to the population of
critical patients to predict early in these patients the possibility of development of
delirium , facilitating the specific application of not pharmacological preventive
measurements in patient who is in high risk. These preventive measurements would be done
across an individualized intervention and they would be focused to: to improve the
orientation, cognitive stimulation , early mobilization, listen to music, in patients of
high risk, Inouye & others (1999) All this , focused to improve the cognition of the
patients and to avoid the cognitive deterioration presented during the stay in the ICU
and that can remain after the departure of the patient in the ICU, Inouye
- others (1999) Additionally identifying in a specific way the patients who has a benefit
from the preventive measurements optimizes the time of personnel of health, reducing the
incidence of the delirium, turns into a strategy cost- benefit for the persons and the
relatives also for the institution on having diminished the hospitable stay, adverse
events and the morbi- mortality . Inouye & others (1990). It is of clarifying and
admitting that now some institutions make different interventions, which tackle the
prevention of the delirium, however , these interventions are realized in an isolated
way, associated with the interest and motivation of the personnel, there do not exist
organized and systematized processes that they allow to face and link to the whole
personnel , the recognition of the delirium during the hospitalization in the ICU , and
although they interfere in the process , there do no exist very few concrete proposals
that reflect in wich way institutions impact the presentation and prevention of the
delirium . In the same way , the services of intensive care unit has been unidentified
that the recommendations with regard to the care and prevention of the delirium tend yo
be generalized, without dedicating enough time to the recognition of the problems,
neither is clear the process of pursuit that is done, to the needs and to the result of
the realized interventions . To the date conclusive studies are not known in this
subject and there has not been proved the efficacy of not pharmacological interventions
directed to the prevention of the delirium in critics patients, only there exist the
modality of the study of doctor Inouye and collaborators in 1999 who verified a decrease
of 30% of the delirium with the implementation of these measurements in hospitalized
aged patients. Inouye & others (1999) Bearing in mind the serious and irreversible
consequences of the delirium to shortly and long term in the critical patients, we want
to propose the implementation of not pharmacological measurements to prepare this
phenomenon and simultaneously to prove the efficacy in patients that diagnoses a high
risk of development of delirium as the application of the scale PREDELIRIC version
validated in spanish The investigation on the prediction of the delirium , of indirect
form will tackle these problematic , generating knowledge on the real e situation,
favoring the identification of courses that will face processes, qualification of the
personnel and making of a guide of intervention in nursing focus on the diminish the
frenzy of the intensive unit care of the country One admits that beyond the requested
for the regulations , the training and permanent accompaniment is needed for the team of
health as regards the attention humanized in highly specializing and technological
stages as it is the ICU To obtain new knowledge that they can contribute to the
comprehension and the sensitization of the situation of the delirium in the persons
hospitalized in the intensive care unit does part of the contribution to the body of
knowledge in the área of critical care , it is so to find a predictor of the
investigation of delirium cost in the intensive care unit strengthens the theoretical
bases to improve the care . There will be beneficiaries of the results of the present
investigation, in addition to the patients , relatives and personnel of health, the
educational institutions of the region , who will have new indications to the academic
programs realizing on the programs of specialization of the área, this way to validate
the care interventions for the user who came to the ICU and improve the offered care.
Generating and applying the results of the present study will be a contribution for the
generation of models of attention in Colombia, directed to a persons who live through an
illness situation and who are hospitalized in ICU , thinking about hoe to high light the
importance of implementing strategies for the advance in the knowledge and the
employment of the results in the formation, practice and investigation to consolidate
the proposals to answer for the needs of this population . The results of the present
study will be presented like a proposal for the institutions and specially for the
intensive care unit adult with the target to offer tools to the care, this will be a
progress of the general satisfaction.
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