Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-28 @ 3:58 AM
Study NCT ID:
NCT05839756
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2023-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Post Extubation Stridor After Maxillomandibular Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D007819', 'term': 'Laryngeal Edema'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The preoperative aerosolized drug will be applied by an anesthetist who is not involved in further patient care'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly allocated into two equal groups via opaque coded envelopes'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-05', 'studyFirstSubmitDate': '2023-04-21', 'studyFirstSubmitQcDate': '2023-05-01', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Expiratory tidal volume immediate after intubation with the cuff deflated', 'timeFrame': 'immediately after intubation', 'description': 'ml'}, {'measure': 'Expiratory tidal volume immediate before extubation with the cuff inflated', 'timeFrame': 'immediately before extubation', 'description': 'ml'}, {'measure': 'Expiratory tidal volume immediate before extubation with the cuff deflated', 'timeFrame': 'immediately before extubation', 'description': 'ml'}, {'measure': 'cuff leak volume', 'timeFrame': 'immediate after intubation and immediate before extubation', 'description': 'ml'}, {'measure': 'Laryngeal air column width', 'timeFrame': 'before intubation', 'description': 'mm'}, {'measure': 'Laryngeal air column width', 'timeFrame': 'immediate after intubation during the balloon-cuff inflation and during balloon-cuff deflation', 'description': 'mm'}, {'measure': 'Laryngeal air column width', 'timeFrame': 'immediate before extubation during the balloon-cuff inflation and during balloon-cuff deflation', 'description': 'mm'}, {'measure': 'Laryngeal air column width difference', 'timeFrame': 'immediate after intubation and immediate before extubation', 'description': 'mm'}, {'measure': 'incidence of postoperative sore throat, dysphonia, swallowing disorders or PES.', 'timeFrame': 'First postoperative day', 'description': '4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)'}], 'primaryOutcomes': [{'measure': 'Laryngeal air column width ratio', 'timeFrame': 'immediately before extubation'}], 'secondaryOutcomes': [{'measure': 'The duration of nasal endotracheal intubation', 'timeFrame': 'Procedure (from nasal endotracheal intubation till extubation)', 'description': 'min'}, {'measure': 'endotracheal tube insertion depth', 'timeFrame': 'immediately after intubation', 'description': 'cm'}, {'measure': 'The incidence of epistasis occurrence during nasotracheal intubation', 'timeFrame': 'immediately after intubation', 'description': '4-point verbal descriptor scale (0=no symptoms, 1=mild, 2=moderate, 3=severe)'}, {'measure': 'Expiratory tidal volume immediate after intubation with the cuff inflated', 'timeFrame': 'immediately after intubation', 'description': 'ml'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stridor', 'Larynx Edema']}, 'descriptionModule': {'briefSummary': 'Endotracheal intubation can induce laryngotracheal injury which results in narrowing of the airway due to edema of the glottis. This can increase the risk of development of post-extubation stridor (PES)', 'detailedDescription': 'Ultrasound (US) is a useful and non-invasive tool for the evaluation of vocal cords and laryngeal morphology in intubated patients. The laryngeal air-column width (LACW), Laryngeal air column width difference (LACWD), and laryngeal air-column width ratio (LACWR) measured by ultrasound can potentially identify patients at risk of post-extubation stridor, in whom caution should be taken after extubation.\n\nThe cuff-leak test can predict successful extubation through using the difference between the expired tidal volume with the cuff inflated and with the cuff deflated; the higher the leak, the lower the likelihood that post-extubation stridor will occur.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients (\\>18 years)\n* American Society of Anesthesiologists status I and II\n* undergoing elective maxillomandibular fixation surgeries under general anesthesia with nasal endotracheal intubation\n\nExclusion Criteria:\n\n* patients' refusal\n* pregnant females\n* patients with body mass index \\<18.5 or ≥ 35 kg/m2\n* risk of aspiration\n* cardiorespiratory disorder\n* neuromuscular disease\n* uncontrolled diabetes mellitus\n* gastrointestinal bleeding\n* on chronic steroid therapy\n* intubated patients or were intubated or had upper airway infection within 1 week prior to surgery\n* history of any pathology, radiotherapy or surgery in the neck\n* had difficult laryngeal US plane (as neck wound)"}, 'identificationModule': {'nctId': 'NCT05839756', 'acronym': 'airway', 'briefTitle': 'Predicting Post Extubation Stridor After Maxillomandibular Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Predicting Post Extubation Stridor in Patients With Intermaxillary Fixation', 'orgStudyIdInfo': {'id': 'Post Extubation Stridor'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control (C) group', 'description': 'normal saline will be nebulized', 'interventionNames': ['Drug: normal saline']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Budesonide (B) group', 'description': 'budesonide will be nebulized', 'interventionNames': ['Drug: budesonide']}], 'interventions': [{'name': 'budesonide', 'type': 'DRUG', 'description': '2 ml nebulized budesonide (containing 1 mg) diluted in 3 ml of normal saline will be nebulized preoperatively', 'armGroupLabels': ['Budesonide (B) group']}, {'name': 'normal saline', 'type': 'DRUG', 'description': '5 ml normal saline will be nebulized preoperatively', 'armGroupLabels': ['control (C) group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35511', 'city': 'Al Mansurah', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Maha A AboZeid', 'role': 'CONTACT', 'email': 'mahazed@yahoo.com'}], 'facility': 'Maha Ahmed AboZeid', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Maha A AboZeid, MD', 'role': 'CONTACT', 'email': 'mahazed@yahoo.com', 'phone': '02-01019216192'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia and Surgical Intensive Care', 'investigatorFullName': 'maha abou-zeid', 'investigatorAffiliation': 'Mansoura University'}}}}