An interventional study of Implementation of management pharmacological protocol of constipation and Implementation of bundle of prevention and non-pharmacological management in Constipation, Critical Illness and Constipation Drug Induced, sponsored by University of Chile. Completed at 1 site in Chile. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-08.
Sponsored by University of Chile · Not applicable, Interventional, and Treatment
Gastrointestinal abnormalities are present in more than 80% of critical patients, and their management has taken an important importance in intensive care unit (ICU), since it can largely determine the clinical outcome, costs and long-term prognosis in This group of patients. Only the constipation in the critical patient has been related to the failure of weaning of the mechanical ventilator, an increase in mechanical ventilation time, and with the increase of the stay in the ICU.
In general, most critical health conditions cause a decrease in the motility of the gastrointestinal tract that intrinsically can contribute to constipation. This is explained by the increase in pro-inflammatory cytokines, increased activity of the sympathetic system, the use of vasopressors, high and prolonged doses of opiates, among others, which can reduce gastric emptying and delay motility. These gastrointestinal abnormalities may be associated with an increase in intra-abdominal pressure, reduced nutritional intake, bacterial hyperproliferation in the digestive tract, intestinal mucosal injury and bacterial translocation through the injured and / or inflamed mucosa. In addition, patients who experience constipation often have gastroparesis and paresis of the ileum, conditions that hinder the progression of nutritional support enterally and worsen the patient's clinical picture.
In spite of being quite common in the ICU, the impact is not known in depth, which implies that these alterations are usually not prevented and on the other hand when treating their pharmacological and non-pharmacological management is highly variable because, for a On the other hand, staff turnover (intensivist physician) and on the other hand because there are no protocols that reduce these problems.
To provide comprehensive care in critical patient units, according to the best available evidence in order to reduce the variation in daily care, clinical guidelines and protocols are applied to manage the various specific problems that affect this group. of patients One way to address the complexity of these problems is through the implementation of care packages, which have taken relevance in the prevention of characteristic events of high mortality and morbidity. It is in this scenario, where the clinical pharmacist plays an important role in the development of protocols, packages and their compliance. The clinical pharmacist is dedicated to the review of the therapy of each patient, through pharmacological conciliation actions with the attending physician, actively participating in the daily round of the multidisciplinary team and at the same time developing "professional support activities" that include , reviews of adverse events associated with medications, education, auditing, research, development of guidelines and institutional protocols for the use of effective and safe medications, with the objective of reducing mortality and its associated costs, thus improving the quality of the Attention.
Given the importance of the problem, it is that this work proposes that the implementation and active dissemination of a constipation bundle/protocol guided by a clinical pharmacist ensures adherence to the strategy in the treatment team and a decrease in the incidence of constipation in the critical patient of the ICU of a university hospital. To fulfill this objective, a quasi-experimental study was designed in which the first stage will be diagnostic observational and a second part of the interventional type, in order to evaluate the effect of adherence to the bundle/protocol on the incidence of constipation in critically ill patients admitted to a ICU of a university hospital for a period of 6 months.
Stages of the study
The project will be carried out in 5 phases distributed in 3 continuous periods of time.
Description of the Phases of the Study
Stage 1
Information from patients hospitalized at the ICU will be collected through a data collection sheet, prospectively to quantify the local magnitude of the constipation and other alterations associated with the decrease in intestinal motility, interventions performed with their results and its consequences.
The data will be collected through a collection form, which will consist of 5 parts:
Stage 2
Protocol and bundle elaboration.
Implementation strategies will be addressed using the EPOC taxonomy (Effective Practice and Organization of Care (EPOC). EPOC taxonomy. Oslo: Norwegian Knowledge Center for the Health Services; 2002). For the purpose of this work only part of the
Interventions aimed at health professionals.
A. Distribution of the protocol and bundles by email and a hard copy to all unit heads. In addition, all the professional prescribers of the unit will be given a hard copy.
B. Educational Talks: Directed to health professionals.
C. Local opinion leaders:
Intervention through the participation of health professionals designated by their colleagues as "educationally influential" (health professionals staff of the ICU, nutritionist, gastroenterologist or others)
D. Reminders: any oral or visual intervention that encourages the health professional to perform a clinical action related to the protocol / bundle. The following interventions are included:
Organizational Interventions:
A. Structural interventions Incorporation of the protocol and bundles in each medical record of the patients included.
Stage 3
The patients included in phase 3 of the study corresponding to the implementation of the package will be patients of the ICU, whatever the applications during the statistics, the set of exclusive controls for each service unit (previously accepted as a package) focused on the prevention of a probable episode of constipation, as long as there is no contraindication (previously described). If a patient included in the corresponding phase of the study will present constipation, the pharmacological management for said health problem will be applied, as specified in their "pharmacological management protocol for constipation" developed and validated together with the package.
These protocol / package interventions will be presented to the health team during medical rounds by both the pharmaceutical chemist responsible for the investigation and by any other professional of the patient's health team in order to comply with the adherence to the protocol / package for each patient
Information from hospitalized patients in the ICU will be collected through a data collection form previously validated in Stage 1. In addition, the following information will be incorporated:
This data will be backed up in an EXCEL (office) format file for later analysis.
Sample size
The universe and the target population will be all admitted patients that meet the inclusion criteria in the period of time in which stage 1 (observational period) and stage 3 (period of implementation and evaluation) of the study are executed
Events to evaluate
In this research paper:
The effectiveness of the analysis of the following definitions shall be understood:
Safety shall be understood as the analysis of adverse events described in the following definitions:
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 66 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →University of Chile is the lead sponsor of 191 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The elaboration of the protocol according to the evidence-based approach, updated evidence found from both search engines such as MEDLINE, EMBASE, Cochrane Library, OVID and ScIELO will be used through the research question using the PICO method (Patient interest, Intervention, Comparation and Outcome). the ready-made protocol will be adjusted to the pharmacological options that are available in the hospital.
Procedure: Implementation of management pharmacological protocol of constipation · Procedure: Implementation of bundle of prevention and non-pharmacological management
first 48 hours: * polyethylene glycol 3350 (about 17 grams) 1 every 8 hours enterally. * Patients who have vomiting and / or gastric residue greater than 500 mL (in a timely measurement every 6 hours) will also be given domperidone 10 mg every 8 hours intravenously. * Patients who have excessive abdominal distension will be administered in addition, levosulpiride 25 mg every 8 hours intravenously. 48 hour evaluation: * Patients who do not have bowel movements will be administered lactulose or sodium phosphate enema. * For patients who do not have a bowel movement, administration of neostigmine intravenously or of naloxone enterally will be evaluated. * Every patient who uses one or more prokinetics will have an electrocardiogram. * Any patient who has bowel movements during management, doses of polyethylene glycol 3350 will be adjusted according to the daily goal of bowel movements, the days of treatment of the prokinetics will be adjusted, for a maximum of 5 consecutive days.
Bundle of prevention: * Start early enteral nutrition. * Optimize and / or decrease opioid doses. * Start early mobilization. Non-pharmacological management bundle * Select laxative and/or prokinetic/s to manage constipation. * Optimize and / or decrease doses of opioids and sedatives. * Start early mobilization. * Pharmacological reconciliation.
Adherence to protocol / bundle implementation.
The adherence for the protocol and for the bundle will be evaluated by being separated. Both will be evaluated by dichotomous evaluation (is adherent or not adherent). It is adherent for the bundle only if all the interventions for the bundle are fulfilled, likewise, it is adherent for the protocol if all the interventions for the protocol are fulfilled.
Time frame: 1 mounth
Difference in incidence of constipation between observational period group and protocol / bundle implementation period group.
Constipation is assessed using the described definition, every day.
Time frame: 1 mounths.
Intolerance to nutritional.
All presence of "gastric residue greater than 500mL in a measurement during the day, or to the presence of vomiting" will be recorded.
Time frame: 1 mounths
Liquid deposition.
all presence of a "deposition of liquid consistency quantified in an amount greater than 200 milliliters" will be recorded.
Time frame: 1 mounths.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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