Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 5:44 PM
Study NCT ID:
NCT07382895
Status:
COMPLETED
Last Update Posted:
2026-02-03
First Post:
2026-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Relationship Between the ASA Score Determined by Operating Room Nurses and Intubation Duration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-25', 'studyFirstSubmitDate': '2026-01-12', 'studyFirstSubmitQcDate': '2026-01-25', 'lastUpdatePostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determining the sociodemographic information of the nurse using "Personal Information Form 1"', 'timeFrame': 'From April 2025 to June 2025', 'description': "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."}, {'measure': 'Determining the sociodemographic information of anesthesiologists using "Personal Information Form 3"', 'timeFrame': 'From April 2025 to June 2025', 'description': "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."}, {'measure': 'Determining the sociodemographic information of the patient\'s using "Personal Information Form 3"', 'timeFrame': 'From April 2025 to June 2025', 'description': "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."}], 'secondaryOutcomes': [{'measure': "Comparing patients' ASA scores with their need for mechanical ventilation", 'timeFrame': 'From April 2025 to June 2025', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ASA Physical Status Classification System', 'preoperative assessment', 'operating room nurse'], 'conditions': ['The Individual Must be 18 Years of Age or Older', 'The Individual Must be Willing to Participate in the Study']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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, 12 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study was conducted at Zonguldak Atatürk State Hospital between 1 April and 1 July 2025. The operating room was staffed by 36 nurses, 12 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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The person must be 18 years of age or older,\n* Must volunteer to participate in the research.\n\nExclusion Criteria:\n\n* The person must be 18 years of age or younger,\n* Not willing to participate in the study,\n* The person must be in ASA VI class,\n* Death must have been considered during surgery.'}, 'identificationModule': {'nctId': 'NCT07382895', 'briefTitle': 'The Relationship Between the ASA Score Determined by Operating Room Nurses and Intubation Duration', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'The Relationship Between the ASA Score Determined by Operating Room Nurses and Intubation Duration', 'orgStudyIdInfo': {'id': '2025-SBB-0079'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Inclusion Criteria for Volunteers in the Study:\n\n* The person must be 18 years of age or older,\n* The person must be willing to participate in the study.\n\nExclusion Criteria for Volunteers in the Study:\n\n* The person must be 18 years of age or younger,\n* The person must not be a volunteer to participate in the study,\n* The person must be classified as ASA VI,\n* The person must have died during surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '67100', 'city': 'Zonguldak', 'state': 'Zonguldak Province', 'country': 'Turkey (Türkiye)', 'facility': 'Zonguldak Atatürk State Hospital', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Patients' personal information was not included in the study and will not be shared."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Zonguldak Ataturk State Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tülin KURT ALKAN', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}