ConstipationmotilityNCT04462211
Constipation Bundle/Protocol and the Effect of Adherence in the Incidence of Constipation in Critically Ill Patients
A study testing Implementation of management pharmacological protocol of constipation and Implementation of bundle of prevention and non-pharmacological management in people with Constipation and Critical Illness, run by University of Chile at 1 site in Chile.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation, Critical Illness, Constipation Drug Induced
- What is being tested?
- Implementation of management pharmacological protocol of constipation and Implementation of bundle of prevention and non-pharmacological management
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChile
- Study dates
- 1 Aug 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient admitted to the intensivo care unit.
- Hospitalization equal to or greater than 3 days.
Who cannot join
- Patient admitted after surgery for resection of the digestive tract.
- Patient with exclusive parenteral nutrition.
- Patient with total intestinal obstruction / ileus, documented during the stay at UPC.
- Patients admitted exclusively for "isolation measures".
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Preparation and Implementation of a Constipation Bundle & Management Protocol and the Effect of Adherence in Reducing the Incidence of Constipation in Critically Ill Patients of a University Hospital
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.
Read more
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.
Read the detailed description
Stages of the study
The project will be carried out in 5 phases distributed in 3 continuous periods of time.
- Stage 1 - 2 month period (observational period).
- Collection of patient information for bundle/protocol development.
- Stage 2 - 3 month period.
- Protocol / bundle development according to evidence-based approach
- Active dissemination of bundle/protocol.
- Stage 3 - 1 month period (implementation and evaluation period)
- Protocol / bundle implementation.
- Collection of patient information, measurement of adherence and evaluation of the effect of the bundle/protocol.
Description of the Phases of the Study
Stage 1
- Collection of patient information for the elaboration of the bundle/protocol.
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:
- Part I: Basic background record (Age, gender, anthropometric data, ICU service you enter, service from which it comes, chronic morbid history).
- Part II: Registration of factors in the patient that may be related to the presence of gastrointestinal motility disorders, as a risk or protective factor during the stay in ICU (type of mechanical ventilation, use of norepinephrine, medicines used in sedoanalgesia, degree of sedation according to SAS scale)
- Part III: Characterization of the nutrition administered to the patient during the stay in ICU (what type of enteral nutrition he is receiving, daily amount of nutrition, daily water balance, amount of bowel movements and if he has diarrhea).
- Part IV: Registry of Laxative/s and/or Prokinetic/s Treatment and its clinical evolution.
- Part V: Identification and Registration of adverse effects associated with the indicated treatment that are clinically evaluable and/or by registration in the nursing and medical record.
Stage 2
- Bundle/protocol development according to evidence-based approach
Protocol and bundle elaboration.
- Active dissemination of a constipation protocol / bundle.
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.
- 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.
- Educational Talks: Directed to health professionals.
- Active education: Session in groups of no more than 10 people, usually carried out in medical visits, as feedback in multidisciplinary reviews of a patient between different professionals of the medical team and/or interconsultores (professionals from other disciplines and/or units other than within the ICU), in order to engage and educate the health professional about the interventions of the protoco and the bundles, and also confirm learning by the professional.
- Passive education: Sessions intended to disseminate information to the prescribing doctors of the entire unit, and to solve doubts globally.
- 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)
- 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:
- Oral reminders (Aimed at both treating physician, medical staff, and nurse between medical visits when there is evidence of suboptimal care for patients included in the study, for example, when a patient is constipated and is not receiving treatment).
- Administrative support (graphics or reminder stickers attached to each patient's box).
Organizational Interventions:
- Structural interventions Incorporation of the protocol and bundles in each medical record of the patients included.
Stage 3
- Implementation of the bundle/protocol in patients admitted during this period, who meet the inclusion criteria and our treating doctors accepted informed consent (if necessary).
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
- Collection of patient information, adherence measurement and evaluation of the effect of the protocol / package.
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:
- Part I to Part V: Identical to the one previously validated.
- Part VI: Applicability of bundle in each of the elements.
- Part VII: Applicability of protocol.
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:
- Adhesion: It will be understood as adherence to the effective fulfillment of the interventions that will be prepared for the protocol and the bundle.
- Constipation: Constipation shall be understood as the presence of "three or more consecutive days without depositions" and prolonged constipation as "six or more consecutive days without depositions". For both definitions, it will be considered as zero day without depositions from the start of enteral nutrition, at most 96 hours after admission to the ICU.
Safety shall be understood as the analysis of adverse events described in the following definitions:
- Intolerance to nutritional support: It is understood as an intolerance to enteral nutritional support to the presence of "gastric residue greater than 500mL in a measurement during the day, or to the presence of vomiting", which will be taken into account in patients who are being given enteral nutrition.
- Liquid deposition: Liquid deposition shall be understood as the presence of a "deposition of liquid consistency quantified in an amount greater than 200 milliliters". It is also synonymous with a diarrheal deposition. *
- Mechanical fan day: A mechanical ventilator day will be considered when the patient requires mechanical ventilator support for more than 12 hours on the day of hospitalization analyzed.
- Conditions
- Constipation, Critical Illness, Constipation Drug Induced
- Being tested
- Implementation of management pharmacological protocol of constipation, Implementation of bundle of prevention and non-pharmacological management
- Medical subject headings
- Constipation, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation of management pharmacological protocol of constipationProcedure or surgery
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.
Implementation of bundle of prevention and non-pharmacological managementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Management pharmacological protocol and bundle's | Experimental | 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. Receives: Procedure: Implementation of management pharmacological protocol of constipation; Procedure: Implementation of bundle of prevention and non-pharmacological management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 mounth
Secondary outcomes (3)
Difference in incidence of constipation between observational period group and protocol / bundle implementation period group.
Constipation is assessed using the described definition, every day.
Measured: 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.
Measured: 1 mounths
Liquid deposition.
all presence of a "deposition of liquid consistency quantified in an amount greater than 200 milliliters" will be recorded.
Measured: 1 mounths.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Aug 2019
- Primary completion1 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Tobar, University of Chile
- Investigators
- José Ignacio JI Farías, Pharmacist, Principal investigator, University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462211
- Sponsor's protocol ID
- OAIC1055/19
- Acronym
- motility
- Status last verified
- Jun 2021
- First submitted
- 19 Dec 2019
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Reintam Blaser A, Malbrain ML, Starkopf J, Fruhwald S, Jakob SM, De Waele J, Braun JP, Poeze M, Spies C. Gastrointestinal function in intensive care patients: terminology, definitions and management. Recommendations of the ESICM Working Group on Abdominal Problems. Intensive Care Med. 2012 Mar;38(3):384-94. doi: 10.1007/s00134-011-2459-y. Epub 2012 Feb 7.
PubMed 22310869Rohm KD, Boldt J, Piper SN. Motility disorders in the ICU: recent therapeutic options and clinical practice. Curr Opin Clin Nutr Metab Care. 2009 Mar;12(2):161-7. doi: 10.1097/MCO.0b013e32832182c4.
PubMed 19202387Btaiche IF, Chan LN, Pleva M, Kraft MD. Critical illness, gastrointestinal complications, and medication therapy during enteral feeding in critically ill adult patients. Nutr Clin Pract. 2010 Feb;25(1):32-49. doi: 10.1177/0884533609357565.
PubMed 20130156Gacouin A, Camus C, Gros A, Isslame S, Marque S, Lavoue S, Chimot L, Donnio PY, Le Tulzo Y. Constipation in long-term ventilated patients: associated factors and impact on intensive care unit outcomes. Crit Care Med. 2010 Oct;38(10):1933-8. doi: 10.1097/CCM.0b013e3181eb9236.
PubMed 20639749Prat D, Messika J, Millereux M, Gouezel C, Hamzaoui O, Demars N, Jacobs F, Trouiller P, Ricard JD, Sztrymf B. Constipation in critical care patients: both timing and duration matter. Eur J Gastroenterol Hepatol. 2018 Sep;30(9):1003-1008. doi: 10.1097/MEG.0000000000001165.
PubMed 29794547Prat D, Messika J, Avenel A, Jacobs F, Fichet J, Lemeur M, Ricard JD, Sztrymf B. Constipation incidence and impact in medical critical care patients: importance of the definition criterion. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):290-6. doi: 10.1097/MEG.0000000000000543.
PubMed 26709885Taylor RW. Gut Motility Issues in Critical Illness. Crit Care Clin. 2016 Apr;32(2):191-201. doi: 10.1016/j.ccc.2015.11.003. Epub 2016 Feb 18.
PubMed 27016161Ukleja A. Altered GI motility in critically Ill patients: current understanding of pathophysiology, clinical impact, and diagnostic approach. Nutr Clin Pract. 2010 Feb;25(1):16-25. doi: 10.1177/0884533609357568.
PubMed 20130154Fruhwald S, Holzer P, Metzler H. Intestinal motility disturbances in intensive care patients pathogenesis and clinical impact. Intensive Care Med. 2007 Jan;33(1):36-44. doi: 10.1007/s00134-006-0452-7. Epub 2006 Nov 18.
PubMed 17115132Mostafa SM, Bhandari S, Ritchie G, Gratton N, Wenstone R. Constipation and its implications in the critically ill patient. Br J Anaesth. 2003 Dec;91(6):815-9. doi: 10.1093/bja/aeg275.
PubMed 14633751Nassar AP Jr, da Silva FM, de Cleva R. Constipation in intensive care unit: incidence and risk factors. J Crit Care. 2009 Dec;24(4):630.e9-12. doi: 10.1016/j.jcrc.2009.03.007. Epub 2009 Jul 9.
PubMed 19592200Patanwala AE, Abarca J, Huckleberry Y, Erstad BL. Pharmacologic management of constipation in the critically ill patient. Pharmacotherapy. 2006 Jul;26(7):896-902. doi: 10.1592/phco.26.7.896.
PubMed 16803421de Azevedo RP, Machado FR. Constipation in critically ill patients: much more than we imagine. Rev Bras Ter Intensiva. 2013 Apr-Jun;25(2):73-4. doi: 10.5935/0103-507X.20130014. No abstract available.
PubMed 23917968Farmer AD, Holt CB, Downes TJ, Ruggeri E, Del Vecchio S, De Giorgio R. Pathophysiology, diagnosis, and management of opioid-induced constipation. Lancet Gastroenterol Hepatol. 2018 Mar;3(3):203-212. doi: 10.1016/S2468-1253(18)30008-6.
PubMed 29870734McPeake J, Gilmour H, MacIntosh G. The implementation of a bowel management protocol in an adult intensive care unit. Nurs Crit Care. 2011 Sep-Oct;16(5):235-42. doi: 10.1111/j.1478-5153.2011.00451.x.
PubMed 21824228
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Preparation and Implementation of a Constipation Bundle & Management Protocol and the Effect of Adherence in Reducing the Incidence of Constipation in Critically Ill Patients of a University Hospital
- ClinicalTrials.gov ID
- NCT04462211
- Acronym / sponsor ID
- motility / OAIC1055/19
- Conditions
- Constipation, Critical Illness, Constipation Drug Induced
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Stages of the study
The project will be carried out in 5 phases distributed in 3 continuous periods of time.
- Stage 1 - 2 month period (observational period).
- Collection of patient information for bundle/protocol development.
- Stage 2 - 3 month period.
- Protocol / bundle development according to evidence-based approach
- Active dissemination of bundle/protocol.
- Stage 3 - 1 month period (implementation and evaluation period)
- Protocol / bundle implementation.
- Collection of patient information, measurement of adherence and evaluation of the effect of the bundle/protocol.
Description of the Phases of the Study
Stage 1
- Collection of patient information for the elaboration of the bundle/protocol.
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:
- Part I: Basic background record (Age, gender, anthropometric data, ICU service you enter, service from which it comes, chronic morbid history).
- Part II: Registration of factors in the patient that may be related to the presence of gastrointestinal motility disorders, as a risk or protective factor during the stay in ICU (type of mechanical ventilation, use of norepinephrine, medicines used in sedoanalgesia, degree of sedation according to SAS scale)
- Part III: Characterization of the nutrition administered to the patient during the stay in ICU (what type of enteral nutrition he is receiving, daily amount of nutrition, daily water balance, amount of bowel movements and if he has diarrhea).
- Part IV: Registry of Laxative/s and/or Prokinetic/s Treatment and its clinical evolution.
- Part V: Identification and Registration of adverse effects associated with the indicated treatment that are clinically evaluable and/or by registration in the nursing and medical record.
Stage 2
- Bundle/protocol development according to evidence-based approach
Protocol and bundle elaboration.
- Active dissemination of a constipation protocol / bundle.
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.
- 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.
- Educational Talks: Directed to health professionals.
- Active education: Session in groups of no more than 10 people, usually carried out in medical visits, as feedback in multidisciplinary reviews of a patient between different professionals of the medical team and/or interconsultores (professionals from other disciplines and/or units other than within the ICU), in order to engage and educate the health professional about the interventions of the protoco and the bundles, and also confirm learning by the professional.
- Passive education: Sessions intended to disseminate information to the prescribing doctors of the entire unit, and to solve doubts globally.
- 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)
- 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:
- Oral reminders (Aimed at both treating physician, medical staff, and nurse between medical visits when there is evidence of suboptimal care for patients included in the study, for example, when a patient is constipated and is not receiving treatment).
- Administrative support (graphics or reminder stickers attached to each patient's box).
Organizational Interventions:
- Structural interventions Incorporation of the protocol and bundles in each medical record of the patients included.
Stage 3
- Implementation of the bundle/protocol in patients admitted during this period, who meet the inclusion criteria and our treating doctors accepted informed consent (if necessary).
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
- Collection of patient information, adherence measurement and evaluation of the effect of the protocol / package.
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:
- Part I to Part V: Identical to the one previously validated.
- Part VI: Applicability of bundle in each of the elements.
- Part VII: Applicability of protocol.
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:
- Adhesion: It will be understood as adherence to the effective fulfillment of the interventions that will be prepared for the protocol and the bundle.
- Constipation: Constipation shall be understood as the presence of "three or more consecutive days without depositions" and prolonged constipation as "six or more consecutive days without depositions". For both definitions, it will be considered as zero day without depositions from the start of enteral nutrition, at most 96 hours after admission to the ICU.
Safety shall be understood as the analysis of adverse events described in the following definitions:
- Intolerance to nutritional support: It is understood as an intolerance to enteral nutritional support to the presence of "gastric residue greater than 500mL in a measurement during the day, or to the presence of vomiting", which will be taken into account in patients who are being given enteral nutrition.
- Liquid deposition: Liquid deposition shall be understood as the presence of a "deposition of liquid consistency quantified in an amount greater than 200 milliliters". It is also synonymous with a diarrheal deposition. *
- Mechanical fan day: A mechanical ventilator day will be considered when the patient requires mechanical ventilator support for more than 12 hours on the day of hospitalization analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Management pharmacological protocol and bundle's | Experimental | Procedure: Implementation of management pharmacological protocol of constipation, Procedure: Implementation of bundle of prevention and non-pharmacological managementThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient admitted to the intensivo care unit.
- Hospitalization equal to or greater than 3 days.
Key exclusion criteria (4 listed)
- Patient admitted after surgery for resection of the digestive tract.
- Patient with exclusive parenteral nutrition.
- Patient with total intestinal obstruction / ileus, documented during the stay at UPC.
- Patients admitted exclusively for "isolation measures".
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation of management pharmacological protocol of constipationfirst 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. | Procedure or surgery | Management pharmacological protocol and bundle's |
| Implementation of bundle of prevention and non-pharmacological managementBundle 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. | Procedure or surgery | Management pharmacological protocol and bundle's |
Primary outcome
Adherence to protocol / bundle implementation.
Time frame: 1 mounth
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.
3 secondary outcomes
Difference in incidence of constipation between observational period group and protocol / bundle implementation period group.
Time frame: 1 mounths.
Intolerance to nutritional.
Time frame: 1 mounths
Liquid deposition.
Time frame: 1 mounths.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Background: PubMed 22310869Reintam Blaser A, Malbrain ML, Starkopf J, Fruhwald S, Jakob SM, De Waele J, Braun JP, Poeze M, Spies C. Gastrointestinal function in intensive care patients: terminology, definitions and management. Recommendations of the ESICM Working Group on Abdominal Problems. Intensive Care Med. 2012 Mar;38(3):384-94. doi: 10.1007/s00134-011-2459-y. Epub 2012 Feb 7.
- Background: PubMed 19202387Rohm KD, Boldt J, Piper SN. Motility disorders in the ICU: recent therapeutic options and clinical practice. Curr Opin Clin Nutr Metab Care. 2009 Mar;12(2):161-7. doi: 10.1097/MCO.0b013e32832182c4.
- Background: PubMed 20130156Btaiche IF, Chan LN, Pleva M, Kraft MD. Critical illness, gastrointestinal complications, and medication therapy during enteral feeding in critically ill adult patients. Nutr Clin Pract. 2010 Feb;25(1):32-49. doi: 10.1177/0884533609357565.
- Background: PubMed 20639749Gacouin A, Camus C, Gros A, Isslame S, Marque S, Lavoue S, Chimot L, Donnio PY, Le Tulzo Y. Constipation in long-term ventilated patients: associated factors and impact on intensive care unit outcomes. Crit Care Med. 2010 Oct;38(10):1933-8. doi: 10.1097/CCM.0b013e3181eb9236.
- Background: PubMed 29794547Prat D, Messika J, Millereux M, Gouezel C, Hamzaoui O, Demars N, Jacobs F, Trouiller P, Ricard JD, Sztrymf B. Constipation in critical care patients: both timing and duration matter. Eur J Gastroenterol Hepatol. 2018 Sep;30(9):1003-1008. doi: 10.1097/MEG.0000000000001165.
- Background: PubMed 26709885Prat D, Messika J, Avenel A, Jacobs F, Fichet J, Lemeur M, Ricard JD, Sztrymf B. Constipation incidence and impact in medical critical care patients: importance of the definition criterion. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):290-6. doi: 10.1097/MEG.0000000000000543.
- Background: PubMed 27016161Taylor RW. Gut Motility Issues in Critical Illness. Crit Care Clin. 2016 Apr;32(2):191-201. doi: 10.1016/j.ccc.2015.11.003. Epub 2016 Feb 18.
- Background: PubMed 20130154Ukleja A. Altered GI motility in critically Ill patients: current understanding of pathophysiology, clinical impact, and diagnostic approach. Nutr Clin Pract. 2010 Feb;25(1):16-25. doi: 10.1177/0884533609357568.
- Background: PubMed 17115132Fruhwald S, Holzer P, Metzler H. Intestinal motility disturbances in intensive care patients pathogenesis and clinical impact. Intensive Care Med. 2007 Jan;33(1):36-44. doi: 10.1007/s00134-006-0452-7. Epub 2006 Nov 18.
- Background: PubMed 14633751Mostafa SM, Bhandari S, Ritchie G, Gratton N, Wenstone R. Constipation and its implications in the critically ill patient. Br J Anaesth. 2003 Dec;91(6):815-9. doi: 10.1093/bja/aeg275.
- Background: PubMed 19592200Nassar AP Jr, da Silva FM, de Cleva R. Constipation in intensive care unit: incidence and risk factors. J Crit Care. 2009 Dec;24(4):630.e9-12. doi: 10.1016/j.jcrc.2009.03.007. Epub 2009 Jul 9.
- Background: PubMed 16803421Patanwala AE, Abarca J, Huckleberry Y, Erstad BL. Pharmacologic management of constipation in the critically ill patient. Pharmacotherapy. 2006 Jul;26(7):896-902. doi: 10.1592/phco.26.7.896.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José Ignacio JI Farías, Pharmacist principal investigator
University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation of management pharmacological protocol of constipation and Implementation of bundle of prevention and non-pharmacological management in people with Constipation and Critical Illness, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to protocol / bundle implementation. (time frame: 1 mounth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04462211, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.