Postoperative DeliriumPODinPOLNCT04250610
Survey Assessing the Level of Knowledge of Postoperative Delirium in Poland.
An observational study of Postoperative Delirium, run by Pomeranian Medical University Szczecin at 2 sites in Poland.
Trial summary
Postoperative Delirium (POD) is one of the most common complications occurring after surgery with an incidence ranging from 4 to 53%. It may lead to increased postoperative morbidity and mortality, with loss of independence and cognitive dysfunction in certain groups of patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Survey
- How many people
- 460 participants
- Where
- 2 sitesPoland
- Study dates
- 27 Feb 2020to 31 Mar 2021
- Phase
- Observational
- 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
Study population: Specialists and residents working in the field of anesthesiology and intensive therapy, members of the Polish Society of Anesthesiology and Intensive Therapy (PTAiIT).
Who may be able to join
- Specialists and residents working in the field of anesthesiology and intensive therapy, anesthesiology nurses who respond to an invitation to an on-line survey of the Polish Society of Anesthesiology and Intensive Therapy (PTAiIT)
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Krzysztof Kusza, MD, PhD contact
Poland2 sites, 2 recruiting
- Recruiting
Medical University in Lublin
Lublin
Wojciech Dąbrowski, MD, PhD, w.dabrowski5@gmail.com
- Recruiting
Pomeranian Medical University
Szczecin, 70-204
Katarzyna Kotfis, MD, PhD
About this study
Official title: Postoperative Delirium in Poland - a Survey Assessing the Level of Knowledge of the POD Problem Among the Staff of Anaesthesiology and Intensive Care Departments.
Postoperative Delirium (POD) is one of the most common complications occurring after surgery with an incidence ranging from 4 to 53%. It may lead to increased postoperative morbidity and mortality, with loss of independence and cognitive dysfunction in certain groups of patients. Aiming to reduce the incidence of POD and improve the outcome of patients diagnosed with POD, it is necessary to raise awareness regarding POD. The most important issue are: identification of risk factors, improved monitoring, necessary prevention and adequate treatment. The Polish Society of Anaesthesiology and Intensive Therapy (PTAiIT) has made an attempt to improve the situation in Poland by testing the implementation of official POD guidelines published by the European Society of Anesthesiology in year 2017. While the guidelines provide recommendations for daily practice it is necessary to identify the degree of their implementation in each country. Therefore survey has been prepared regarding postoperative delirium in Poland. This Survey has been submitted to the Bioethical Committee of the Pomeranian Medical University in Szczecin (Poland) and received a waiver due to the non-interventional, observational character of the study (decision no. KB-0012/06/01/2020/Z).
- Conditions
- Postoperative Delirium
- Being tested
- Survey
- Keywords
- Postoperative delirium, POD, Anesthetics, Neurocognitive Disorders, Central Nervous System, Confusion, Neurologic Manifestations
- Medical subject headings
- Emergence Delirium, Neurocognitive Disorders, Confusion, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
On-line survey.
What is being measured
The primary outcome is the main question the study is designed to answer.
Status of diagnosis of postoperative delirium
Answers of PTAiIT-members regarding instruments used to diagnose postoperative delirium. Anonymous on-line survey including Multiple Choice Questions, Closed and Open Questions.
Measured: Up to 2 months
Secondary outcomes (3)
Identification of postoperative delirium risk factors
Answers of PTAiIT-members regarding risk factors of postoperative delirium. Anonymous on-line survey including Multiple Choice Questions, Closed and Open Questions.
Measured: Up to 2 months
Status of prevention of postoperative delirium
Answers of PTAiIT-members regarding measures of postoperative delirium prevention. Anonymous on-line survey including Multiple Choice Questions, Closed and Open Questions.
Measured: Up to 2 months
Status of treatment of postoperative delirium
Answers of PTAiIT-members regarding measures of postoperative delirium treatment. Anonymous on-line survey including Multiple Choice Questions, Closed and Open Questions.
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start27 Feb 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Kotfis, Pomeranian Medical University Szczecin
- Investigators
- Krzysztof L Kusza, MD, PhD, Study chair, Medical University in Poznań
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250610
- Sponsor's protocol ID
- KB-0012/06/01/2020/Z
- Acronym
- PODinPOL
- Status last verified
- Sep 2020
- First submitted
- 30 Jan 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Delirium in Poland - a Survey Assessing the Level of Knowledge of the POD Problem Among the Staff of Anaesthesiology and Intensive Care Departments.
- ClinicalTrials.gov ID
- NCT04250610
- Acronym / sponsor ID
- PODinPOL / KB-0012/06/01/2020/Z
- Conditions
- Postoperative Delirium
- Keywords
- Postoperative delirium, POD, Anesthetics, Neurocognitive Disorders, Central Nervous System, Confusion, Neurologic Manifestations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 31 Jan 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.
Postoperative Delirium (POD) is one of the most common complications occurring after surgery with an incidence ranging from 4 to 53%. It may lead to increased postoperative morbidity and mortality, with loss of independence and cognitive dysfunction in certain groups of patients. Aiming to reduce the incidence of POD and improve the outcome of patients diagnosed with POD, it is necessary to raise awareness regarding POD. The most important issue are: identification of risk factors, improved monitoring, necessary prevention and adequate treatment. The Polish Society of Anaesthesiology and Intensive Therapy (PTAiIT) has made an attempt to improve the situation in Poland by testing the implementation of official POD guidelines published by the European Society of Anesthesiology in year 2017. While the guidelines provide recommendations for daily practice it is necessary to identify the degree of their implementation in each country. Therefore survey has been prepared regarding postoperative delirium in Poland. This Survey has been submitted to the Bioethical Committee of the Pomeranian Medical University in Szczecin (Poland) and received a waiver due to the non-interventional, observational character of the study (decision no. KB-0012/06/01/2020/Z).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Specialists and residents working in the field of anesthesiology and intensive therapy, members of the Polish Society of Anesthesiology and Intensive Therapy (PTAiIT).
Key inclusion criteria (1 listed)
- Specialists and residents working in the field of anesthesiology and intensive therapy, anesthesiology nurses who respond to an invitation to an on-line survey of the Polish Society of Anesthesiology and Intensive Therapy (PTAiIT)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| SurveyOn-line survey. | Other | – |
Primary outcome
Status of diagnosis of postoperative delirium
Time frame: Up to 2 months
Answers of PTAiIT-members regarding instruments used to diagnose postoperative delirium. Anonymous on-line survey including Multiple Choice Questions, Closed and Open Questions.
3 secondary outcomes
Identification of postoperative delirium risk factors
Time frame: Up to 2 months
Status of prevention of postoperative delirium
Time frame: Up to 2 months
Status of treatment of postoperative delirium
Time frame: Up to 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Individual participant dataSharing planned: No
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Dementia, Postoperative Delirium (POD)
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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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.
Krzysztof Kusza, MD, PhD contact
Krzysztof L Kusza, MD, PhD study chair
Medical University in Poznań
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Delirium, run by Pomeranian Medical University Szczecin at 2 sites in Poland.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna L Kotfis, MD, PhD (+48 91 466 1144, katarzyna.kotfis@pum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Status of diagnosis of postoperative delirium (time frame: Up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2020.