Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT06107751
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ramped and Sniffing Position for Cesarean Section Intubation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'Due to the nature of the study, patients and care providers will be blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "There are two group;\n\n1. Experimental Group: Group R; Ramped Group; Pillows will be placed under the patient's upper body and head, with the external auditory canal and sternal notch horizontal.\n2. Sham Comparator: Group S; Sniffing Group; A 7 cm high pillow will be placed under the occiput while the patient is in the supine position."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-13', 'studyFirstSubmitDate': '2023-10-20', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Total intubation time', 'timeFrame': '5 minutes after induction of general anesthesia', 'description': 'Total intubation time will be calculated by adding up the laryngoscopy time and tube insertion time.'}], 'secondaryOutcomes': [{'measure': 'Incidence of difficult intubation', 'timeFrame': '5 minutes after induction of general anesthesia', 'description': 'The Intubation Difficulty Scale (IDS) will be used to define the intubation difficulty. Intubation is considered easy if IDS=0, slight difficulty if 0 \\< IDS \\< 5, Moderate to Major Difficulty if 5 \\< IDS, impossible if IDS = ∞.'}, {'measure': 'Incidence of difficult mask ventilation', 'timeFrame': '5 minutes after induction of general anesthesia', 'description': 'The Warters Scale will be used to define the mask ventilation difficulty. Difficult mask ventilation is defined as a score ≥ 4 on the Warters scale'}, {'measure': 'Laryngoscopy time', 'timeFrame': '5 minutes after induction of general anesthesia', 'description': 'The timing measurements will begin when the videolaryngoscope blade first passes between the teeth and will end when the best glottic view is obtained on the videolaryngoscopy monitor.'}, {'measure': 'Tube insertion time', 'timeFrame': '5 minutes after induction of general anesthesia', 'description': 'The timing measurements will begin when the endotracheal tube first passes between the teeth and ended when the tube passes through the glottis.'}, {'measure': 'Complications related to intubation', 'timeFrame': 'postoperative 4th hour', 'description': 'A postoperative follow-up assessment will be performed approximately 4 hr after surgery by a co-investigator blinded to the intubation position to evaluate the presence and severity of sore throat, any changes in voice, trauma to the lip, tongue, palate, or teeth.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean section', 'Intubation', 'Videolaryngoscopy'], 'conditions': ['Intubation; Difficult or Failed']}, 'descriptionModule': {'briefSummary': 'This study will include pregnants who preferred to undergo general anesthesia for elective cesarean section. Ramped and sniffing positions of pregnant women during ventilation and intubation will be compared. The aim of this study is to investigate which position provides easier and faster intubation in pregnant women for cesarean section.', 'detailedDescription': 'Estimates of the frequency of difficult and failed intubation in the obstetric population vary within a wide range of percentiles. Several times higher than those reported for the general surgery population. Functional Residual Capacity decreases by 10% - 25% in Pregnant women. Pregnant women are more susceptible to hypoxia as a result of this decline, which also encourages intubation to occur more rapidly. Intubation success and shortening of intubation time have improved positively with videolaryngoscopes. On the other hand, the position of the patient during intubation contributes to the speed and success of intubation. It has been shown that intubation is faster and first-pass success is higher in the ramped position in morbidly obese patients.This study will compare the effectiveness of ramp and sniffing positions on intubation time and success in obese patients and pregnant women with similar physical changes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Since intubation time for cesarean section will be evaluated, only female patients will be studied.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with American Society of Anesthesiologists physical status classification of II-III, who are planned for elective cesarean section, who are between the ages of 18 and 40, and who prefer general anesthesia will be included.\n\nExclusion Criteria:\n\n* Patients who refuse to participate in the study, have orientation and cooperation disorders, have undergone head and neck surgery, have a history of difficult intubation, have a cervical spine defect, and have a risk of pulmonary aspiration will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06107751', 'briefTitle': 'Ramped and Sniffing Position for Cesarean Section Intubation.', 'organization': {'class': 'OTHER', 'fullName': 'Karaman Training and Research Hospital'}, 'officialTitle': 'Comparison of Ramped and Sniffing Positions in Video-laryngoscopy-guided Tracheal Intubation for Elective Cesarean Section: a Prospective Randomized Study.', 'orgStudyIdInfo': {'id': '05-2023/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ramped position group', 'description': 'This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus', 'interventionNames': ['Other: Ramped position group']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sniffing position group', 'description': 'This position will be achieved by placing a 7 cm pillow under the occiput.', 'interventionNames': ['Other: Sniffing position group']}], 'interventions': [{'name': 'Ramped position group', 'type': 'OTHER', 'otherNames': ['Ramped position'], 'description': 'This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus', 'armGroupLabels': ['Ramped position group']}, {'name': 'Sniffing position group', 'type': 'OTHER', 'otherNames': ['Sniffing group'], 'description': 'This position will be achieved by placing a 7 cm pillow under the occiput.', 'armGroupLabels': ['Sniffing position group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70200', 'city': 'Karaman', 'country': 'Turkey (Türkiye)', 'facility': 'Karaman Training and Research Hospital', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'overallOfficials': [{'name': 'Muhammet Korkusuz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karamanoğlu Mehmetbey University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karaman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD', 'investigatorFullName': 'muhammet korkusuz', 'investigatorAffiliation': 'Karaman Training and Research Hospital'}}}}