The Frequency of Anesthesia-related Critical EventsNCT06426940
Anesthesia-Related Peroperative Critical Events
An observational study of The Frequency of Anesthesia-related Critical Events and Anesthesia-related Intraoperative Critical Events, run by Gamze Küçükosman at 1 site in Turkey (Türkiye).
Trial summary
Peroperative anesthesia-related critical events (CE) lead to adverse health outcomes in patients. To minimize recurrence of these outcomes, identifying problems causing CEs and obtaining information about their frequency and severity are important. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- The Frequency of Anesthesia-related Critical Events, Anesthesia-related Intraoperative Critical Events, Anesthesia-related Postoperative Critical Events
- What is being tested?
- anesthesia-related critical events
- How many people
- 1,904 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2020to 1 Sep 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Age, gender, ASA (the American Society of Anesthesiologists) risk, surgical clinic, anesthesia method (general/regional/local/sedation/local+sedation), anesthesia and surgery duration of the patients, and anesthesia-related CEs occurring within intraoperative and postoperative 1 h were recorded.
Who may be able to join
- All patients
Who cannot join
- intubated outside the operating room
- taken into operation from the intensive care unit (ICU).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gamze Küçükosman
Zonguldak, Zonguldak Province
About this study
Official title: Prospective Analysis of Anesthesia-Related Peroperative Critical Events in a Tertiary Care Hospital
Peroperative anesthesia-related critical events (CE) lead to adverse health outcomes in patients. To minimize recurrence of these outcomes, identifying problems causing CEs and obtaining information about their frequency and severity are important. This study aims to determine the frequency of anesthesia-related CEs occurring within intraoperative and postoperative 1 hour (h) in surgical patients at our tertiary care hospital, by system.
- Conditions
- The Frequency of Anesthesia-related Critical Events, Anesthesia-related Intraoperative Critical Events, Anesthesia-related Postoperative Critical Events
- Being tested
- anesthesia-related critical events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia-related critical eventsOther
anesthesia-related critical events
| Study group | Role | What they receive |
|---|---|---|
| intraoperative anesthesia-related critical events | Not described Receives: Other: anesthesia-related critical events | |
| postoperative 1 hour (h)anesthesia-related critical events | Not described Receives: Other: anesthesia-related critical events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospective Analysis of Anesthesia-Related Peroperative Critical Events in a Tertiary Care Hospital
This study aims to determine the frequency of anesthesia-related CEs occurring within intraoperative and postoperative 1 hour (h) in surgical patients at our tertiary care hospital, by system.
Measured: anesthesia-related intraoperative and within postoperative 1 hour critical events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start1 Mar 2020
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Frequency of Anesthesia-related Critical EventsStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,904 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gamze Küçükosman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gamze Küçükosman, Zonguldak Bulent Ecevit University
- Investigators
- gamze küçükosman, Principal investigator, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426940
- Sponsor's protocol ID
- SBÜTrabzon
- Status last verified
- May 2024
- First submitted
- 19 May 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Anesthesia-Related Peroperative Critical Events in a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT06426940
- Acronym / sponsor ID
- SBÜTrabzon
- Conditions
- The Frequency of Anesthesia-related Critical Events, Anesthesia-related Intraoperative Critical Events, Anesthesia-related Postoperative Critical Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,904 participants (actual)
- Lead sponsor
- Gamze KüçükosmanUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 23 May 2024 (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.
Peroperative anesthesia-related critical events (CE) lead to adverse health outcomes in patients. To minimize recurrence of these outcomes, identifying problems causing CEs and obtaining information about their frequency and severity are important. This study aims to determine the frequency of anesthesia-related CEs occurring within intraoperative and postoperative 1 hour (h) in surgical patients at our tertiary care hospital, by system.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraoperative anesthesia-related critical events | – | Other: anesthesia-related critical events |
| postoperative 1 hour (h)anesthesia-related critical events | – | Other: anesthesia-related critical events |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Age, gender, ASA (the American Society of Anesthesiologists) risk, surgical clinic, anesthesia method (general/regional/local/sedation/local+sedation), anesthesia and surgery duration of the patients, and anesthesia-related CEs occurring within intraoperative and postoperative 1 h were recorded.
Key inclusion criteria (1 listed)
- All patients
Key exclusion criteria (2 listed)
- intubated outside the operating room
- taken into operation from the intensive care unit (ICU).
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 |
|---|---|---|
| anesthesia-related critical eventsanesthesia-related critical events | Other | intraoperative anesthesia-related critical events, postoperative 1 hour (h)anesthesia-related critical events |
Primary outcome
Prospective Analysis of Anesthesia-Related Peroperative Critical Events in a Tertiary Care Hospital
Time frame: anesthesia-related intraoperative and within postoperative 1 hour critical events
This study aims to determine the frequency of anesthesia-related CEs occurring within intraoperative and postoperative 1 hour (h) in surgical patients at our tertiary care hospital, by system.
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 27 Jan 2025.
- Individual participant dataSharing planned: Undecided
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.
gamze küçükosman principal investigator
Zonguldak Bulent Ecevit University
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 The Frequency of Anesthesia-related Critical Events and Anesthesia-related Intraoperative Critical Events, run by Gamze Küçükosman 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 2 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 27 Jan 2025. 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?
Prospective Analysis of Anesthesia-Related Peroperative Critical Events in a Tertiary Care Hospital (time frame: anesthesia-related intraoperative and within postoperative 1 hour critical events). 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 27 Jan 2025.