Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-18 @ 1:24 PM
Study NCT ID:
NCT05224895
Status:
UNKNOWN
Last Update Posted:
2022-02-15
First Post:
2021-12-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Trendelenburg Position on the Ultrasonographic Airway Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}, {'id': 'D018475', 'term': 'Head-Down Tilt'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-14', 'studyFirstSubmitDate': '2021-12-26', 'studyFirstSubmitQcDate': '2022-02-03', 'lastUpdatePostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preoperative Tongue thickness', 'timeFrame': 'Baseline, preoperative', 'description': 'When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness'}, {'measure': 'postoperative Tongue thickness1', 'timeFrame': 'immediately postextubation', 'description': 'When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness'}, {'measure': 'postoperative Tongue thickness2', 'timeFrame': 'postoperative 2. hour', 'description': 'When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness'}, {'measure': 'preoperative Tongue volume', 'timeFrame': 'Baseline, preoperative', 'description': 'Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width'}, {'measure': 'postoperative Tongue volume1', 'timeFrame': 'immediately postextubation', 'description': 'Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width'}, {'measure': 'postoperativeTongue volume2', 'timeFrame': 'postoperative 2. hour', 'description': 'Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width'}, {'measure': 'Preoperative Lateral parapharyngeal wall thickness', 'timeFrame': 'Baseline, preoperative', 'description': 'The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured'}, {'measure': 'postoperative Lateral parapharyngeal wall thickness1', 'timeFrame': 'immediately postextubation', 'description': 'The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured'}, {'measure': 'postoperative Lateral parapharyngeal wall thickness2', 'timeFrame': 'postoperative 2. hour', 'description': 'The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured'}, {'measure': 'Number of participants with Critical respiratory events', 'timeFrame': 'Within postoperative 2 hours', 'description': 'A PACU critical respiratory event (CRE), any unexpected hypoxemia (hemoglobin oxygen saturation \\< 90%), hypoventilation (respiratory rate \\< 8 bpm or arterial carbon dioxide tension \\> 50 mmHg), or upper airway obstruction (stridor or laryngospasm) will be considered as requiring active and specific intervention (ventilation, tracheal intubation, opioid or muscle relaxant antagonism, oral/nasal airway or airway manipulation).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Airway edema', 'ultrasonography', 'Robotic surgical procedures', 'Postoperative Respiratory Complication'], 'conditions': ['Airway Edema', 'Ultrasonography', 'Robotic Surgical Procedures', 'Postoperative Respiratory Complication']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the changes in upper airway edema with the preoperative and postoperative ultrasonographic measurements of patients who undergo pobotic prostatectomy in the trendelenburg position.\n\nThe secondary aim is to investigate the correlation between OSAS risk levels determined by the STOP-BANG score in the preoperative period of the patients participating in the study airway ultrasound measurements and postoperative critical respiratory events in the preoperative and postoperative period.', 'detailedDescription': 'In the preoperative period, age, body weight, height, neck circumference, comorbidities (Charlson comorbidity index), ASA score, Modified mallampati classification, STOP-BANG risk score will be recorded.Intraoperative monitorization data will be recorded.\n\nFollowing ultrasonographic airway measurements will be performed preoperatively and postoperatively.\n\nA low frequency convex probe will be used for ultrasonography. To achieve a fixed position of the tongue, patients will be placed supine without a pillow, with their head fully tilted back, and asked to hold their tongue loosely, without phonation, with their mouth closed and tongue tips lightly touching the incisors. The probe will be placed under the chin in the median sagittal plane and adjusted to obtain a clear median sagittal tongue view.\n\nTongue thickness: When the ultrasound probe is placed under the chin on the median sagittal plane, with the mouth closed in the supine position, the tongue is in a natural position and the patient is silent, and the tongue root is displayed on the screen, the maximal vertical diameter from the tongue surface to the submental skin will be measured and recorded as tongue thickness .\n\nMedian sagittal tongue cross-sectional area: The sagittal cross-sectional area of the tongue will then be measured by tracing the circumference of the tongue on the ultrasound machine.\n\nTongue width: The tongue width will then be obtained by measuring the distance between the probe placed transversely under the chin and the furthest points in the middle of the tongue in order to obtain as complete a tongue contour as possible.\n\nTongue volume: Tongue volume will then be obtained by multiplying the mid-sagittal tongue cross-sectional area by the tongue width, as described in previous studies .\n\nLateral parapharyngeal wall thickness: The lateral parapharyngeal wall thickness will be measured with a linear probe placed laterally into the cervical region in the direction of the external auditory canal to visualize the branching of the carotid artery. The lateral edge of the pharynx will be visualized as a hyperechoic line. Vibration artifacts and pharyngeal position will be confirmed by swallowing the patient. The distance between the arteria carotid interna and the echogenic surface of the pharynx and the distance between the skin and the lateral wall of the pharynx will be measured .\n\nPatients will be monitorized for critical respiratory events (CRE) postoperatively A PACU CRE is defined as, any unexpected hypoxemia (hemoglobin oxygen saturation \\< 90%), hypoventilation (respiratory rate \\< 8 bpm or arterial carbon dioxide tension \\> 50 mmHg), or upper airway obstruction (stridor or laryngospasm) will be considered as requiring active and specific intervention (ventilation, tracheal intubation, opioid or muscle relaxant antagonism, oral/nasal airway or airway manipulation).\n\n1. Upper airway obstruction requiring intervention (jaw thrust, oral airway);\n2. Mild to moderate hypoxemia (SpO2=93%-90%) that does not improve after active interventions in 3 L nasal cannula oxygen (increasing O2 flows to \\>3 L/min, high-flow surface application mask O2, verbal requests to breathe deeply, tactile stimulation);\n3. Severe hypoxemia (SpO2\\<90%) on 3 L nasal cannula O2, hypoxemia that does not improve after treatment (increased O2 flows \\>3 L/min, high-flow face mask O2 application, verbal requests deep breathing, tactile stimulation);\n4. Respiratory distress or signs of impending respiratory failure (respiratory rate \\>20/min, use of accessory muscles, tracheal tugging);\n5. Inability to take deep breaths when requested by the PACU nurse;\n6. The patient complains of symptoms of respiratory or upper airway muscle weakness (difficulty breathing, swallowing or speaking);\n7. Patient requiring reintubation in the PACU;\n8. Clinical evidence or suspected pulmonary aspiration after tracheal extubation (gastric contents and hypoxemia observed in the oropharynx)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'participants who undergo robotic prostatectomy in Ankara City Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Robotic Laparoscopic Prostatectomy\n2. ASA I-II-III-IV risk group -\n\nExclusion Criteria:\n\n1. contraindication of trendelenburg position,\n2. history of maxillofacial deformity, tumor or trauma,\n3. history of difficult airway,\n4. decompensated cardiac, respiratory, hepatic, renal disease,\n5. with cervical spine fracture\n6. patient refusal -'}, 'identificationModule': {'nctId': 'NCT05224895', 'briefTitle': 'The Effect of Trendelenburg Position on the Ultrasonographic Airway Measurements', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Evaluation of the Effect of Trendelenburg Position on the Ultrasonographic Airway Measurements and Critical Respiratory Events', 'orgStudyIdInfo': {'id': 'E1-21-2231'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General Anesthesia in Trendelenburg position for robotic prostatectomy', 'interventionNames': ['Procedure: General Anesthesia in Trendelenburg position for robotic prostatectomy']}], 'interventions': [{'name': 'General Anesthesia in Trendelenburg position for robotic prostatectomy', 'type': 'PROCEDURE', 'description': 'in this arm, changes in preoperative and postoperative airway measurements and correlation with postoperative critical airway events will be monitored.', 'armGroupLabels': ['General Anesthesia in Trendelenburg position for robotic prostatectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06800', 'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'İsmail Aytac', 'role': 'CONTACT', 'email': 'aytacismail1972@gmail.com', 'phone': '+905056340369'}], 'facility': 'Ankara City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'ismail aytac', 'role': 'CONTACT', 'email': 'aytacismail1972@gmail.com', 'phone': '+905056340369'}, {'name': 'betül güven aytaç', 'role': 'CONTACT', 'email': 'drbguven@hotmail.com', 'phone': '+905073578351'}], 'overallOfficials': [{'name': 'betül güven aytaç', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ankara ch bilkent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'ismail aytaç', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}