Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-29 @ 11:31 PM
Study NCT ID:
NCT07391969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of SaCo VLMA for General Anesthesia for Laparoscopic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064346', 'term': 'Sagittal Abdominal Diameter'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D049628', 'term': 'Body Size'}, {'id': 'D001837', 'term': 'Body Weights and Measures'}, {'id': 'D001824', 'term': 'Body Constitution'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000886', 'term': 'Anthropometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'the collected data will be anonymized regarding used for airway control device'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-01-02', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effectiveness of use', 'timeFrame': 'immediately after the intervention', 'description': 'success ratio of insertion of SGA or ET in % of success insertion'}, {'measure': 'effectiveness of mechanical ventilation', 'timeFrame': 'perioperatively', 'description': 'adequate ventilation described as maintaining adequate minute ventilation with acceptable leak in Tidal Volume in ml'}, {'measure': 'safety of mechanical ventilation', 'timeFrame': 'perioperatively', 'description': 'providing adequate ventilation parameters - peak pressure in mmHg'}, {'measure': 'parameters of mechanical ventilation', 'timeFrame': 'perioperatively', 'description': 'measurement of lung compliance in ml/mmHg'}], 'secondaryOutcomes': [{'measure': 'safety of use of SaCo VLM', 'timeFrame': 'immediately after the surgery', 'description': 'complications ratio related to airway management in %'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopic Surgical Procedures', 'Airway Control', 'Anesthesia']}, 'descriptionModule': {'briefSummary': 'Evaluation of new supraglottic device SaCo VLMA for laparoscopic procedures under general anesthesia in comparison with other airway management methods including other supraglottic devices. The parameters noted will be: demographic data, time for placement of SGA counted from moment of grabbing device by operator to correct placement, subjective evaluation of ease of insertion of SGA in 5 step Borg scale, peak pressure, lung compliance, achieved tidal volume before creating pneumoperitoneum, after creating pneumoperitoneum, visualization of glottis on monitor of camera or fiberoptic scope.', 'detailedDescription': 'Evaluation of new supraglottic device SaCo VLMA for laparoscopic procedures under general anesthesia in comparison of other supraglottic devices and other methods of airway management for such procedures.\n\nThe airway management for laparoscopic surgery can be achieved by either endotracheal intubation (ET) or use of supraglottic devices (SGA). However, many anesthesiologist still prefer ET over use of SGA because of possible problems with adequate ventilation during pneumoperitoneum.\n\nNew SGA devices as video laryngeal mask offer important advantage which is continuous control of proper placement of SGA during anesthesia. In case of ventilation difficulties like leak, high peak pressure, low tidal volume SGA VLM allow to check if the problem is related to malposition or changed of position of SGA and allow for correction under control of vision.\n\nThe aim of this study is to evaluate the characteristics of the SaCo VLMA video laryngeal mask in the hands of experienced anesthesiologists.\n\nAll patients will be anesthetized following the same protocol: Intravenous induction with propofol, FNT, midazolam, rocuronium in standard doses. After achieving proper muscle relaxation SaCo VLMA was inserted following manufacturer recommendations. For maintaining anesthesia sevoflurane was used.\n\nAfter induction for anesthesia the airway of the patient will be secured by one randomly chosen device: SaCo VLMA or other SGA or ET.\n\nThe parameters noted will be: demographic data, time for placement of SGA counted from moment of grabbing device by operator to correct placement, subjective evaluation of ease of insertion of SGA in 5 step Borg scale, peak pressure, lung compliance, achieved tidal volume before creating pneumoperitoneum, after creating pneumoperitoneum, visualization of glottis on monitor of camera or fiberoptic scope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective surgery under general anesthesia for laparoscopic surgery of predicting lasting no longer than about 1 hour.\n* Age \\>18 years.\n* ASA I-III.\n* Present ordinary airway\n\nExclusion Criteria:\n\n* Not meeting the above criteria\n* Presenting 3 predictors of a difficult airway (Mallampatti class III or IV; thyromental distance \\<6 cm, sternomental distance \\<12.5 cm, distance between incisors \\<4.0 cm, bite test II or III, cervical mobility \\<90o).\n* Gestation\n* Allergy to any drug included in the protocol.\n* Present risk factors for bronchial aspiration\n\n \\- Presenting with preoperative sore throat\n* Present severe respiratory, coronary or cerebral vascular pathology.'}, 'identificationModule': {'nctId': 'NCT07391969', 'briefTitle': 'Evaluation of SaCo VLMA for General Anesthesia for Laparoscopic Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lodz'}, 'officialTitle': 'Evaluation of New Supraglottic Airway Device - SaCo VLMA for General Anesthesia for Laparoscopic Procedures', 'orgStudyIdInfo': {'id': 'RNN/120/23/KE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SaCo VLMA airway management', 'description': 'SaCo VLMA Supraglottic Airway Device for airway control in anesthetized patient for general anesthesia for laparoscopic surgery', 'interventionNames': ['Device: SaCo VLM or SAD or ET for airway control for laparoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Other device for airway management', 'description': 'Other Airway Device for airway control in anesthetized patient for general anesthesia for laparoscopic surgery', 'interventionNames': ['Device: SaCo VLM or SAD or ET for airway control for laparoscopy']}], 'interventions': [{'name': 'SaCo VLM or SAD or ET for airway control for laparoscopy', 'type': 'DEVICE', 'description': 'Evaluation of the new SGAs for airway control in anesthetized patients for laparoscopy procedures', 'armGroupLabels': ['Other device for airway management', 'SaCo VLMA airway management']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Tomasz Gaszynski', 'role': 'CONTACT', 'email': 'tomasz.gaszynski@umed.lodz.pl', 'phone': '693462098', 'phoneExt': '+48'}, {'name': 'Paweł Ratajczyk', 'role': 'CONTACT', 'email': 'pawel.ratajczyk@umed.lodz.pl', 'phone': '693462098', 'phoneExt': '+48'}], 'overallOfficials': [{'name': 'Tomasz Gaszynski', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Lodz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lodz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr hab.', 'investigatorFullName': 'Tomasz Gaszynski', 'investigatorAffiliation': 'Medical University of Lodz'}}}}