Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-04 @ 6:12 PM
Study NCT ID:
NCT06627660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-04
First Post:
2024-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055092', 'term': 'Laryngomalacia'}, {'id': 'D007826', 'term': 'Laryngismus'}], 'ancestors': [{'id': 'D002357', 'term': 'Cartilage Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D064706', 'term': 'Vocal Cord Dysfunction'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014636', 'term': 'Valsalva Maneuver'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'INTERVENTIONAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2024-10-03', 'studyFirstSubmitQcDate': '2024-10-03', 'lastUpdatePostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of laryngospasm', 'timeFrame': '24 HOURS'}], 'secondaryOutcomes': [{'measure': 'incidence of reintubation', 'timeFrame': '24 HOURS'}, {'measure': 'Postoperative oxygen saturation measurement', 'timeFrame': '1 HOUR', 'description': 'Oxygen saturation (%) is recorded every 5 minutes'}, {'measure': 'Incidence of postoperative nausea and vomiting', 'timeFrame': '24 HOURS'}, {'measure': 'Duration of postoperative hospital stay', 'timeFrame': '24 HOURS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VALSALVA MANEUVER', 'Postoperative Laryngospasm', 'Supraglottoplasty'], 'conditions': ['Laryngomalacia', 'Laryngospasm']}, 'referencesModule': {'references': [{'pmid': '29368315', 'type': 'BACKGROUND', 'citation': 'Kumar CM, Van Zundert AAJ. Intraoperative Valsalva maneuver: a narrative review. Can J Anaesth. 2018 May;65(5):578-585. doi: 10.1007/s12630-018-1074-6. Epub 2018 Jan 24.'}, {'pmid': '27260594', 'type': 'BACKGROUND', 'citation': 'Ramprasad VH, Ryan MA, Farjat AE, Eapen RJ, Raynor EM. Practice patterns in supraglottoplasty and perioperative care. Int J Pediatr Otorhinolaryngol. 2016 Jul;86:118-23. doi: 10.1016/j.ijporl.2016.04.039. Epub 2016 May 3.'}, {'pmid': '18315632', 'type': 'BACKGROUND', 'citation': 'Alalami AA, Ayoub CM, Baraka AS. Laryngospasm: review of different prevention and treatment modalities. Paediatr Anaesth. 2008 Apr;18(4):281-8. doi: 10.1111/j.1460-9592.2008.02448.x.'}, {'type': 'BACKGROUND', 'citation': 'Hernández-Cortez E. Update on the management of laryngospasm. J Anesth Crit Care Open Access. 2018;8(2):1-6.'}, {'pmid': '32411216', 'type': 'BACKGROUND', 'citation': 'Birlie Chekol W, Yaregal Melesse D. Incidence and Associated Factors of Laryngospasm among Pediatric Patients Who Underwent Surgery under General Anesthesia, in University of Gondar Compressive Specialized Hospital, Northwest Ethiopia, 2019: A Cross-Sectional Study. Anesthesiol Res Pract. 2020 Jan 24;2020:3706106. doi: 10.1155/2020/3706106. eCollection 2020.'}, {'type': 'BACKGROUND', 'citation': 'Oshan V and Robert WM. Anesthesia for complex airway surgery in children. Continuing Education in Anesthesia, Critical care and Pain 2013;13:47-51'}]}, 'descriptionModule': {'briefSummary': 'We hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia.\n\nPrimary outcome: Incidence of postoperative stridor and laryngospasm Secondary outcome: incidence of reintubation, postoperative hemodynamics, duration of postoperative ICU and hospital stay', 'detailedDescription': 'Congenital Laryngomalacia is the main cause of stridor in newborns and infants, affecting 45-75% of all infants with congenital stridor. Short aryepiglottic folds, redundant arytenoid, omega-shaped epiglottis, and inspiratory stridor are features of laryngomalacia. Pediatric laryngospasm is a glottic closure due to reflex constriction of the laryngeal muscles that produce partial or complete obstruction of the larynx. When complete and sustained, laryngospasm is considered an anesthetic Emergency.\n\nThe valsalva maneuver involves expiratory effort against a closed glottis in the sitting or supine position with the intraoral and intrathoracic pressures raised to 40 mmHg for 15-20 sec, after which the pressure is suddenly released and the breathing restored to normal.\n\nWe hypothesized that manual valsalva maneuver prevent incidence of postoperative laryngospasm after supraglottoplasty for cases of congenital laryngomalacia.\n\nAfter approval of IRB, Mansoura University, this study will be conducted on infants and children ASA I or II aging from 1 month age- 6 years undergoing supraglottoplasty in Mansoura university hospitals. After obtaining a written informed consent from patients parents, random number generator with closed envelope technique will randomize patients into two groups \\[control\\] group ( C group ), Valsalva group ( V group)\\].\n\nAnesthesia will be induced by inhalational induction using sevoflurane at concentration (6:8%). After that, a proper sized cannula will be introduced with giving atropine 0,01mg/kg and hydrocortisone 4mg/ kg. Then, patients will be seen by fiberoptic endoscopy by the surgeon to detect the stage of laryngomalacia and the supraglottic pathology. After that, proper sized ETT will be inserted using succinylcholine 1mg\\\\kg IV and fixed in place after confirmation of correct positioning , with maintenance of anesthesia with isoflurane. All patients will be given 0.5-1mic /kg fentanyl and 15 mg /kg paracetamol.\n\nA pilot study will be done including 5 patients in each study group. The Incidence of postoperative stridor will be used as the primary variable with difference between studied groups was 40% (50% in group C versus 10% in group V). G\\*power software version 3.1.9.2 will be utilized to detect the required sample size for a study power of 90% and alpha error of 0.05. Cases involved in the pilot study will not be included in the total sample size of the study. Then total sample size will be 26 in each group and by adding 10% to compensate for possible drop out then total sample size per group will be 29 cases in each group. Perioperative data will be tabulated and analyzed using IBM SPSS software version 26.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Month', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants and children ASA I or II aging from 1 month age - 6 years undergoing supraglottoplasty\n\nExclusion Criteria:\n\n* Parents refusal.\n* Patients with increased ICP\n* Patients with increased IOP'}, 'identificationModule': {'nctId': 'NCT06627660', 'briefTitle': 'Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Manual Valsalva Maneuver As a Preventive Measure of Postoperative Laryngospasm in Laryngomalacia Cases Undergoing Supraglottoplasty', 'orgStudyIdInfo': {'id': 'Valsalva for laryngospasm'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group C', 'description': 'Control group'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group V', 'description': 'Repeated Valsalva maneuver will be done after recovery from anesthesia', 'interventionNames': ['Procedure: Valsalva maneuver']}], 'interventions': [{'name': 'Valsalva maneuver', 'type': 'PROCEDURE', 'description': 'Closure of the nose and mouth during expiration for 20 sec', 'armGroupLabels': ['Group V']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'SAMEH FATHY ELSHERBINY, DOCTORAL DEGREE (MD)', 'role': 'CONTACT', 'email': 'SMFSHERBINY@YAHOO.COM', 'phone': '002-0100-6500748'}], 'overallOfficials': [{'name': 'Ahmed Elshahat Aboelfoutouh, DOCTORAL DEGREE (MD)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Anesthesia and Surgical Intensive Care - Faculty of medicine - Mansoura university'}, {'name': 'Rania Elmohamady Elbadrawy, DOCTORAL DEGREE (MD)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Anesthesia and Surgical Intensive Care- Faculty of medicine - Mansoura university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sameh Fathy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sameh Mohamed Fathy El-Sherbiny, MD, Assistant Professor at Mansoura Faculty of Medicine', 'investigatorFullName': 'Sameh Fathy', 'investigatorAffiliation': 'Mansoura University'}}}}