Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-03-29 @ 5:50 PM
Study NCT ID:
NCT06712732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-10
First Post:
2024-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Evaluation of Laryngeal Mask Airway (LMA) Placement in Pediatric Patients and Its Relationship to Postoperative Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-11-26', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation between PRAE incidence and correlation with ultrasound score', 'timeFrame': 'From enrollment to the discharge from the recovery room', 'description': 'The aim of this observational study is to evaluate whether there is a correlation between ultrasonographic data and the incidence of postoperative complications in pediatric patients undergoing general anesthesia for surgery, in order to evaluate the possible predictive power on complications of this diagnostic technique. Postoperative complications or PRAE (Perioperative Respiratory Adverse Events) are: major complications (bronchospasm and laryngospasm) and minor complications (desaturation \\<95%, signs of airway obstruction with increased effort of accessory respiratory muscles and/or snoring, severe cough for more than 10s continuously, postoperative stridor, presence of blood traces at removal of the LMA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paediatric Airway']}, 'descriptionModule': {'briefSummary': 'This study was designed to improve understanding of some respiratory reactions that can occur after surgery, such as difficulty breathing or persistent cough. These events, technically called PRAE (postoperative respiratory complications), are common reactions in children who have undergone surgery, and our aim is to find out if there are signs that can help us predict them, reducing their incidence in the future.\n\nDuring surgery, the child will receive general anesthesia, which will put him or her to sleep and not feel pain. In this context, a laryngeal mask airway (LMA) will be used to help the child breathe. The laryngeal mask airway is a soft device that is placed in the throat and allows the airway to be kept open, making breathing possible. This is a standard tool that will be used during surgery regardless of participation in the study.\n\nThe aim of this study is to better understand the relationship between the correct positioning of the laryngeal mask airway, measured by a specific ultrasound score, and the frequency of postoperative respiratory events in pediatric patients. As previously stated, these complications are common and well known in pediatric anesthesia practice, and the study aims to explore whether adequate ultrasound assessment can help predict and prevent them in the future. The study aims to observe the position of the laryngeal mask airway through a simple ultrasound and verify whether there is a relationship between the way the mask is positioned and the possibility of postoperative respiratory events. This type of ultrasound is non-invasive and does not add risk to the child.\n\nThis ultrasound check will take place without affecting the normal treatment of the patient and does not involve any additional risk or discomfort.\n\nThe study is purely observational: this means that we will collect information without modifying in any way the care already foreseen for the child.\n\nThe laryngeal mask airway and neck ultrasound are already part of standard medical practice, and the study does not present any additional risks. In this case, it is only a matter of reporting in all children who will participate in the study the "results" of ecological story of the neck (which we will process according to a score) and to evaluate whether there is a relationship between this score and the occurrence of respiratory adverse events upon awakening.\n\nThe overall duration of the study is 24 months. In total, we expect to include about 340 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients undergoing surgery under general anesthesia with laryngeal mask airway placement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing surgery under general anesthesia with laryngeal mask airway placement.\n\nExclusion Criteria:\n\n* Patients without the need for invasive airway management or undergoing surgery requiring orotracheal intubation.\n* Patients with known craniofacial malformations.\n* Patients undergoing neck surgery.'}, 'identificationModule': {'nctId': 'NCT06712732', 'acronym': 'LMAUSPED', 'briefTitle': 'Ultrasound Evaluation of Laryngeal Mask Airway (LMA) Placement in Pediatric Patients and Its Relationship to Postoperative Complications', 'organization': {'class': 'OTHER', 'fullName': 'University Of Perugia'}, 'officialTitle': 'Valutazione Ultrasonografica Del Corretto Posizionamento Della Maschera Laringea Nel Paziente Pediatrico', 'orgStudyIdInfo': {'id': 'LMAUSPED'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rachele Simonte', 'role': 'CONTACT', 'email': 'rachele.simonte@gmail.com', 'phone': '+39 075578 2420'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Of Perugia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Researcher', 'investigatorFullName': 'Rachele Simonte', 'investigatorAffiliation': 'University Of Perugia'}}}}