Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-31 @ 11:17 PM
Study NCT ID:
NCT05712135
Status:
UNKNOWN
Last Update Posted:
2023-02-03
First Post:
2022-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Endotracheal Cuff Pressure Changes According to Different Positions in Neurosurgery Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016683', 'term': 'Supine Position'}, {'id': 'D016684', 'term': 'Prone Position'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-06-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-25', 'studyFirstSubmitDate': '2022-11-27', 'studyFirstSubmitQcDate': '2023-01-25', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effect of cuff pressure on postoperative sore throat', 'timeFrame': '24 hours', 'description': 'The primary outcome of the study was intubated under general anesthesia, endotracheal cuff of patients in supine, prone, semi-fowler position is to observe the change of pressures according to the positions.'}], 'secondaryOutcomes': [{'measure': 'Comparison of cuff pressure changes with cuff time according to groups', 'timeFrame': '8 hours', 'description': 'Secondary outcome of the study, case length on endotracheal cuff pressure is to observe.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cuff pressure', 'postoperative dysphagia', 'different positions in neurosurgery'], 'conditions': ['The Effect of Cuff Pressure on Postoperative Dysphagia']}, 'descriptionModule': {'briefSummary': 'We aimed to measure the change in cuff pressure in different positions in neurosurgery cases and to investigate the effect of case length on cuff pressure.', 'detailedDescription': 'It is an observational study, the cuffs of the endotracheal tubes of the patients who were intubated under general anesthesia between February 2023 and May 2023 will be inflated at 25 cm H2O pressure, and then the pressure line and the pilot balloon will be connected to the anesthesia monitor. The cuff pressure of the patient will be measured from the pilot balloon throughout the case and recorded at half-hour intervals. Postoperative sore throat will be evaluated on the VAS scale. Postoperative cough, hoarseness, and dysphagia symptoms will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neurosurgery patients between the ages of 18-70 under general anesthesia in the operating room between February 2022 and April 2022.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neurosurgery patients between the ages of 18-70 ages\n* American Society of Anesthesiologist score I-II-III-IV\n\nExclusion Criteria:\n\n* Patients with previous tracheostomy\n* Patients with tracheal stenosis\n* Patients considered as difficult intubation\n* Patients who have had more than one intubation attempt\n* Patients with an ASA score greater than 4\n* Patient who has difficulty understanding visual analog scale (VAS) scores\n* Language / communication barrier\n* Patients younger than 18 years old'}, 'identificationModule': {'nctId': 'NCT05712135', 'briefTitle': 'Investigation of Endotracheal Cuff Pressure Changes According to Different Positions in Neurosurgery Cases', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Investigation of Endotracheal Cuff Pressure Changes According to Different Positions in Neurosurgery Cases', 'orgStudyIdInfo': {'id': 'E2-22-1369'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'supine', 'description': 'The patient group whose cuff pressure was measured in the supine position in neurosurgery', 'interventionNames': ['Other: supine position']}, {'label': 'prone', 'description': 'The patient group whose cuff pressure was measured in the prone position in neurosurgery', 'interventionNames': ['Other: prone position']}, {'label': 'semi-fowler', 'description': 'The patient group whose cuff pressure was measured in the semi-fowler position in neurosurgery', 'interventionNames': ['Other: semi-fowler position']}], 'interventions': [{'name': 'supine position', 'type': 'OTHER', 'description': 'The patient group whose cuff pressure was measured in the supine position', 'armGroupLabels': ['supine']}, {'name': 'prone position', 'type': 'OTHER', 'description': 'The patient group whose cuff pressure was measured in the prone position', 'armGroupLabels': ['prone']}, {'name': 'semi-fowler position', 'type': 'OTHER', 'description': 'The patient group whose cuff pressure was measured in the semi-fowler position', 'armGroupLabels': ['semi-fowler']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sena Sarıcaoglu Oktem, Resident', 'role': 'CONTACT', 'email': 'senasaricaoglu@gmail.com', 'phone': '+90 538 600 2190'}, {'name': 'Mehmet Sahap, Specialist', 'role': 'CONTACT', 'email': 'drsahap@gmail.com', 'phone': '+90 533 682 6254'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant doctor', 'investigatorFullName': 'sena sarıcaoğlu', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}