Critical IllnessNCT03488069
Sedation Practices and Preferences of Turkish Intensive Care Physicians: National Survey
An observational study of Critical Illness and Sedation, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Sedation is one of the most common practices applied in intensive care units (ICU) and the management of sedation, analgesia and delirium is a quality measure in ICUs. Several intensive care societies published guidelines regarding the use of sedatives and analgesics recently. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Critical Illness, Sedation
- What is being tested?
- Survey
- How many people
- 429 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Aug 2017to 1 Nov 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All intensive care physicians that are the member of Turkish Society of Intensive Care
Who may be able to join
- All physicians accepting to participate the survey
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa Medical School
Istanbul, 34098
About this study
Sedation is one of the most common practices applied in intensive care units (ICU) and the management of sedation, analgesia and delirium is a quality measure in ICUs. Several intensive care societies published guidelines regarding the use of sedatives and analgesics recently. In literature there are many survey studies investigating practices of sedation in ICUs of different countries, but knowledge of the sedation practices of intensive care physicians in Turkey is lacking. The aim of this study was to provide a baseline knowledge on this matter and to establish some points to be improved. An electronic survey form, consisting of 34 questions was generated with google forms, posted to 1700 email addresses and 429 returned (25%). The survey included questions about demographics and choices and routines of sedation, analgesia, neuromuscular blockers and delirium administration. Ninety-six percent of the respondents indicated that they practiced sedation in their ICUs and mechanical ventilation was checked as the primary indication (94%). On the question regarding drug choices for sedation, midazolam was the most preferred agent (90%). About pain questions, the most used evaluation tool was visual analogue scale (69.0%) and 83% of the respondents preferred to use tramadol for pain, followed by paracetamol (81.6%). Of the participants, 50.5% indicated that they routinely evaluated delirium and 56% of them used confussion assessment method for ICU. The awareness of 2013 American College of Critical Care Medicine (ACCM) guideline for the management of pain, agitation, and delirium was only 38%. The results of this survey have indicated some areas to be improved, such as low incidence of written sedation protocols, frequent use of benzodiazepines, and delirium screening. A national guideline should be prepared taking pain, agitation, and delirium in focus.
Read the detailed description
This national survey study and questionnaire was approved by the institutional ethics committee of Istanbul University, Cerrahpasa Medical School (approval nr. 261075, date 07.07.2017).
An electronic survey form consisting of 34 questions was generated with google forms (https://docs.google.com/forms) after a literature search with search words "sedation" and "practice" and "survey".
The first part of the form included questions about demographics, intensive care, and hospital characteristics. The second part contained questions on choices and routines of sedation administration, which multiple choices could be indicated.
The questions were first pilot tested for misunderstandings with the ICU physicians in two intensive care units, and the link for the survey was posted to all email addresses registered in the Turkish Society of Intensive Care member database (1700 members) on 2.8.2017. A second notification was sent to same email addresses on 16.10.2017 with a notice of not to reply the survey if it was replied after the first email. Participation in the survey was voluntary and anonymous, and there was no compensation for participation.
Accepting responses to the survey was stopped in 01/11/2017, and answers were downloaded from the web site.
Statistical Analysis The answers were analyzed using Excel spreadsheets (Microsoft Corporation, Redmond, WA, USA). The demographic data are expressed as mean (±SD) and counts and percentages. The answers regarding sedation practices are expressed as counts and percentages. No statistical comparisons had been made as this was a descriptive study.
- Conditions
- Critical Illness, Sedation
- Being tested
- Survey
- Keywords
- critical care, sedation, practice, survey
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Submission of survey answers
What is being measured
The primary outcome is the main question the study is designed to answer.
Practices and preferences of sedation
Collection of answers to the survey
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start2 Aug 2017
- Primary completion1 Nov 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seval urkmez, Istanbul University
- Investigators
- seval urkmez, MD, Principal investigator, IU, Cerrahpasa Medical School, Dept of Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488069
- Sponsor's protocol ID
- 261075
- Status last verified
- Apr 2018
- First submitted
- 28 Mar 2018
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Urkmez S, Erdogan E, Utku T, Dikmen Y. Sedation Practices and Preferences of Turkish Intensive Care Physicians: A National Survey. Turk J Anaesthesiol Reanim. 2019 Jun;47(3):220-227. doi: 10.5152/TJAR.2019.49799. Epub 2019 Feb 24.
PubMed 31183469
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Practices and Preferences of Turkish Intensive Care Physicians: National Survey
- ClinicalTrials.gov ID
- NCT03488069
- Acronym / sponsor ID
- 261075
- Conditions
- Critical Illness, Sedation
- Keywords
- critical care, sedation, practice, survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 4 Apr 2018 (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.
Sedation is one of the most common practices applied in intensive care units (ICU) and the management of sedation, analgesia and delirium is a quality measure in ICUs. Several intensive care societies published guidelines regarding the use of sedatives and analgesics recently. In literature there are many survey studies investigating practices of sedation in ICUs of different countries, but knowledge of the sedation practices of intensive care physicians in Turkey is lacking. The aim of this study was to provide a baseline knowledge on this matter and to establish some points to be improved. An electronic survey form, consisting of 34 questions was generated with google forms, posted to 1700 email addresses and 429 returned (25%). The survey included questions about demographics and choices and routines of sedation, analgesia, neuromuscular blockers and delirium administration. Ninety-six percent of the respondents indicated that they practiced sedation in their ICUs and mechanical ventilation was checked as the primary indication (94%). On the question regarding drug choices for sedation, midazolam was the most preferred agent (90%). About pain questions, the most used evaluation tool was visual analogue scale (69.0%) and 83% of the respondents preferred to use tramadol for pain, followed by paracetamol (81.6%). Of the participants, 50.5% indicated that they routinely evaluated delirium and 56% of them used confussion assessment method for ICU. The awareness of 2013 American College of Critical Care Medicine (ACCM) guideline for the management of pain, agitation, and delirium was only 38%. The results of this survey have indicated some areas to be improved, such as low incidence of written sedation protocols, frequent use of benzodiazepines, and delirium screening. A national guideline should be prepared taking pain, agitation, and delirium in focus.
Detailed description
This national survey study and questionnaire was approved by the institutional ethics committee of Istanbul University, Cerrahpasa Medical School (approval nr. 261075, date 07.07.2017).
An electronic survey form consisting of 34 questions was generated with google forms (https://docs.google.com/forms) after a literature search with search words "sedation" and "practice" and "survey".
The first part of the form included questions about demographics, intensive care, and hospital characteristics. The second part contained questions on choices and routines of sedation administration, which multiple choices could be indicated.
The questions were first pilot tested for misunderstandings with the ICU physicians in two intensive care units, and the link for the survey was posted to all email addresses registered in the Turkish Society of Intensive Care member database (1700 members) on 2.8.2017. A second notification was sent to same email addresses on 16.10.2017 with a notice of not to reply the survey if it was replied after the first email. Participation in the survey was voluntary and anonymous, and there was no compensation for participation.
Accepting responses to the survey was stopped in 01/11/2017, and answers were downloaded from the web site.
Statistical Analysis The answers were analyzed using Excel spreadsheets (Microsoft Corporation, Redmond, WA, USA). The demographic data are expressed as mean (±SD) and counts and percentages. The answers regarding sedation practices are expressed as counts and percentages. No statistical comparisons had been made as this was a descriptive study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All intensive care physicians that are the member of Turkish Society of Intensive Care
Key inclusion criteria (1 listed)
- All physicians accepting to participate the survey
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 |
|---|---|---|
| SurveySubmission of survey answers | Other | – |
Primary outcome
Practices and preferences of sedation
Time frame: 3 months
Collection of answers to the survey
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 9 Apr 2018.
- Derived from this study: PubMed 31183469Urkmez S, Erdogan E, Utku T, Dikmen Y. Sedation Practices and Preferences of Turkish Intensive Care Physicians: A National Survey. Turk J Anaesthesiol Reanim. 2019 Jun;47(3):220-227. doi: 10.5152/TJAR.2019.49799. Epub 2019 Feb 24.
- Individual participant dataSharing planned: Undecided
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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.
seval urkmez, MD principal investigator
IU, Cerrahpasa Medical School, Dept of Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Sedation, run by Istanbul University at 1 site in Turkey (Türkiye).
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: finished, as of the sponsor's last update on 9 Apr 2018. 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 Turkey (Türkiye). 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?
Practices and preferences of sedation (time frame: 3 months). 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 NCT03488069, which also lists 1 linked publication.
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 9 Apr 2018.