The Individual Must be 18 Years of Age or OlderNCT07382895
The Relationship Between the ASA Score Determined by Operating Room Nurses and Intubation Duration
An observational study of The Individual Must be 18 Years of Age or Older and The Individual Must be Willing to Participate in the Study, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study is to The objective of this study was to ascertain the extent to which operating room nurses assign ASA scores and to assess the reliability of these scores in predicting significant risk factors, including the necessity for mechanical ventilation in patients. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- The Individual Must be 18 Years of Age or Older, The Individual Must be Willing to Participate in the Study
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 1 Jul 2025
- How long will I take part?
- 3 Months
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study was conducted at Zonguldak Atatürk State Hospital between 1 April and 1 July 2025. The operating room was staffed by 36 nurses, 36 anesthesiologists (across 12 operating tables) and 80 patients. A review of extant research on the subject was conducted, and a G Power analysis was subsequently performed. This analysis indicated that, in order to achieve 80% power within a 95% confidence interval for an effect size of d=0.8, it is necessary to include 80 individuals meeting the inclusion criteria in the study.
Who may be able to join
- The person must be 18 years of age or older,
- Must volunteer to participate in the research.
Who cannot join
- The person must be 18 years of age or younger,
- Not willing to participate in the study,
- The person must be in ASA VI class,
- Death must have been considered during surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Atatürk State Hospital
Zonguldak, Zonguldak Province, 67100
About this study
The objective of this study is to The objective of this study was to ascertain the extent to which operating room nurses assign ASA scores and to assess the reliability of these scores in predicting significant risk factors, including the necessity for mechanical ventilation in patients.
Read the detailed description
The present research is to be conducted as a prospective observational study. The present prospective observational study is to be conducted over a 3-month period between April 1, 2025, and July 1, 2025, at a single centre, with the involvement of 36 nurses, 36 anesthesiologists (12 operating tables), and 80 patients working in the operating room of Zonguldak Atatürk State Hospital, who evaluate patients in a pre- and post-operative assessment clinic. The sociodemographic information of the nurses and anesthesiologists will be recorded using "Personal Information Form 1" and "Personal Information Form 2". Prior to undergoing surgery, patients' ASA scores and sociodemographic information will be evaluated by operating room nurses and anesthesiologists, who will record this data using "Personal Information Form 3". Patients will be followed up until they are discharged from the clinic, and their mechanical ventilation needs will be recorded. The ASA scores assigned by operating room nurses and anesthesiologists will be analysed in relation to the necessity for mechanical ventilation.
- Conditions
- The Individual Must be 18 Years of Age or Older, The Individual Must be Willing to Participate in the Study
- Keywords
- ASA Physical Status Classification System, preoperative assessment, operating room nurse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Inclusion Criteria for Volunteers in the Study: * The person must be 18 years of age or older, * The person must be willing to participate in the study. Exclusion Criteria for Volunteers in the Study: * The person must be 18 years of age or younger, * The person must not be a volunteer to participate in the study, * The person must be classified as ASA VI, * The person must have died during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining the sociodemographic information of the nurse using "Personal Information Form 1"
The nurse's assessment is a nine-item form that includes information such as age, gender, professional work experience, experience working in an operating room, work style, average weekly working hours, income level, and whether or not they have received ASA Physical Status Classification training.
Measured: From April 2025 to June 2025
Determining the sociodemographic information of anesthesiologists using "Personal Information Form 3"
This is an 8-item form that includes the anesthesiologist's age, gender, professional work experience, operating room experience, work style, average weekly working hours, income level, and whether they have received ASA Physical Status Classification training.
Measured: From April 2025 to June 2025
Determining the sociodemographic information of the patient's using "Personal Information Form 3"
This is an 8-item form that includes the patient's age, gender, chronic diseases, previous surgical procedures, Glasgow Coma Scale score, ASA class score, need for mechanical ventilation, and number of days the patient has been intubated.
Measured: From April 2025 to June 2025
Secondary outcomes (1)
Comparing patients' ASA scores with their need for mechanical ventilation
The ASA scores given to patients by operating room nurses and anesthesiologists will be compared with the likelihood of them needing mechanical ventilation. For analyzing the differences between two independent groups with a normal distribution, an independent t-test will be applied; for analyzing the differences between more than two independent groups, an ANOVA test will be applied.
Measured: From April 2025 to June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Apr 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Individual Must be 18 Years of Age or OlderStudies 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
- Cross-sectional
- Enrolment
- 80 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Collaborators
- Zonguldak Ataturk State Hospital
- Responsible party
- Principal investigator, Tülin KURT ALKAN, Zonguldak Bulent Ecevit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382895
- Sponsor's protocol ID
- 2025-SBB-0079
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patients' personal information was not included in the study and will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the ASA Score Determined by Operating Room Nurses and Intubation Duration
- ClinicalTrials.gov ID
- NCT07382895
- Acronym / sponsor ID
- 2025-SBB-0079
- Conditions
- The Individual Must be 18 Years of Age or Older, The Individual Must be Willing to Participate in the Study
- Keywords
- ASA Physical Status Classification System, preoperative assessment, operating room nurse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Collaborators
- Zonguldak Ataturk State Hospital
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 3 Feb 2026 (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.
The objective of this study is to The objective of this study was to ascertain the extent to which operating room nurses assign ASA scores and to assess the reliability of these scores in predicting significant risk factors, including the necessity for mechanical ventilation in patients.
Detailed description
The present research is to be conducted as a prospective observational study. The present prospective observational study is to be conducted over a 3-month period between April 1, 2025, and July 1, 2025, at a single centre, with the involvement of 36 nurses, 36 anesthesiologists (12 operating tables), and 80 patients working in the operating room of Zonguldak Atatürk State Hospital, who evaluate patients in a pre- and post-operative assessment clinic. The sociodemographic information of the nurses and anesthesiologists will be recorded using "Personal Information Form 1" and "Personal Information Form 2". Prior to undergoing surgery, patients' ASA scores and sociodemographic information will be evaluated by operating room nurses and anesthesiologists, who will record this data using "Personal Information Form 3". Patients will be followed up until they are discharged from the clinic, and their mechanical ventilation needs will be recorded. The ASA scores assigned by operating room nurses and anesthesiologists will be analysed in relation to the necessity for mechanical ventilation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Inclusion Criteria for Volunteers in the Study: * The person must be 18 years of age or older, * The person must be willing to participate in the study. Exclusion Criteria for Volunteers in the Study: * The person must be 18 years of age or younger, * The person must not be a volunteer to participate in the study, * The person must be classified as ASA VI, * The person must have died during surgery. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study was conducted at Zonguldak Atatürk State Hospital between 1 April and 1 July 2025. The operating room was staffed by 36 nurses, 36 anesthesiologists (across 12 operating tables) and 80 patients. A review of extant research on the subject was conducted, and a G Power analysis was subsequently performed. This analysis indicated that, in order to achieve 80% power within a 95% confidence interval for an effect size of d=0.8, it is necessary to include 80 individuals meeting the inclusion criteria in the study.
Key inclusion criteria (2 listed)
- The person must be 18 years of age or older,
- Must volunteer to participate in the research.
Key exclusion criteria (4 listed)
- The person must be 18 years of age or younger,
- Not willing to participate in the study,
- The person must be in ASA VI class,
- Death must have been considered during surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determining the sociodemographic information of the nurse using "Personal Information Form 1"
Time frame: From April 2025 to June 2025
The nurse's assessment is a nine-item form that includes information such as age, gender, professional work experience, experience working in an operating room, work style, average weekly working hours, income level, and whether or not they have received ASA Physical Status Classification training.
Determining the sociodemographic information of anesthesiologists using "Personal Information Form 3"
Time frame: From April 2025 to June 2025
This is an 8-item form that includes the anesthesiologist's age, gender, professional work experience, operating room experience, work style, average weekly working hours, income level, and whether they have received ASA Physical Status Classification training.
Determining the sociodemographic information of the patient's using "Personal Information Form 3"
Time frame: From April 2025 to June 2025
This is an 8-item form that includes the patient's age, gender, chronic diseases, previous surgical procedures, Glasgow Coma Scale score, ASA class score, need for mechanical ventilation, and number of days the patient has been intubated.
1 secondary outcome
Comparing patients' ASA scores with their need for mechanical ventilation
Time frame: From April 2025 to June 2025
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 26 Aug 2026.
- Individual participant dataSharing planned: No. Patients' personal information was not included in the study and will not be shared.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Individual Must be 18 Years of Age or Older and The Individual Must be Willing to Participate in the Study, run by Zonguldak Bulent Ecevit 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 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 26 Aug 2026. 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?
Determining the sociodemographic information of the nurse using "Personal Information Form 1" (time frame: From April 2025 to June 2025). The study lists 3 primary outcomes in all. 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 26 Aug 2026.