Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-26 @ 2:19 AM
Study NCT ID:
NCT04507594
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2020-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Diaphragmatic Dysfunction After Thoracic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-31', 'studyFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2020-08-09', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in excursion of the diaphragm', 'timeFrame': 'Prior to surgery to 14 days after surgery', 'description': 'Ultrasonographic measure with M-mode of Diaphragmatic Excursion on right hemidiaphragm'}], 'secondaryOutcomes': [{'measure': 'Ultrasonographic measure of the difference in Intrathoracic Area', 'timeFrame': 'Prior to surgery to 14 days after surgery', 'description': 'Intrathoracic Area is measured at inspiration and expiration to calculate the difference in Intrathoracic Area during breathing'}, {'measure': 'Change in Diaphragmatic Thickening Fraction', 'timeFrame': 'Prior to surgery to 14 days after surgery', 'description': 'Ultrasonographic measurement'}, {'measure': 'Change in Intercostal Muscle Thickening Fraction', 'timeFrame': 'Prior to surgery to 14 days after surgery', 'description': 'Ultrasonographic measurement'}, {'measure': 'Change in forced expired volume within the first second (FEV1)', 'timeFrame': 'Prior to surgery to 14 days after surgery', 'description': 'Spirometry'}, {'measure': 'Change in forced vital capacity (FEV)', 'timeFrame': 'Prior to surgery to 14 days after surgery', 'description': 'Spirometry'}, {'measure': 'Change in peak flow', 'timeFrame': 'Prior to surgery to 14 days after surgery', 'description': 'Spirometry'}, {'measure': 'Change in Electromyographic measure of Maximal Diaphragmatic Response after stimulating the phrenic nerve', 'timeFrame': 'Prior to surgery to 14 days after surgery'}, {'measure': 'Change in Electromyographic measure of Latency of Diaphragmatic Response after stimulating the phrenic nerve', 'timeFrame': 'Prior to surgery to 14 days after surgery'}, {'measure': 'Change in 6 Minutes Walk Test', 'timeFrame': 'Prior to surgery to 14 days after surgery', 'description': 'Maximum Walking Distance within 6 minutes'}, {'measure': 'Change in visual analogue scale score', 'timeFrame': 'Prior to surgery to 14 days after surgery', 'description': 'Scoring system for subjective sensation of pain ranging from 0 to 10. Higher numbers signify higher pain sensations'}, {'measure': 'Accumulated Opiod Use after Surgery', 'timeFrame': 'Prior to surgery to 14 days after surgery', 'description': 'Morphine equivalents'}, {'measure': 'Postoperative Pulmonary Complications', 'timeFrame': 'Prior to surgery to 30 days after surgery', 'description': 'Comprising:\n\n1. Pneumonia\n2. Atelectasis\n3. Bronchospasm\n4. Hypoxemia\n5. Severe Hypoxemia\n6. Pleural Effusion 1 \\> cm\n7. Pneumothorax\n8. CPAP or NIV required after 1. postoperative day'}, {'measure': 'Admission days at the Intensive Care Unit after Surgery', 'timeFrame': 'Prior to surgery to 60 days after surgery'}, {'measure': 'Number of Admissions after Discharge from the Surgical Department', 'timeFrame': 'Prior to surgery to 60 days after surgery'}, {'measure': 'Accumulated Admission Days at any Hospital', 'timeFrame': 'Prior to surgery to 60 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diaphragm Injury', 'Phrenic Nerve Paralysis', 'Thoracic Cancer', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '38546897', 'type': 'DERIVED', 'citation': 'Norskov J, Skaarup SH, Bendixen M, Tankisi H, Morkved AL, Juhl-Olsen P. Diaphragmatic dysfunction is associated with postoperative pulmonary complications and phrenic nerve paresis in patients undergoing thoracic surgery. J Anesth. 2024 Jun;38(3):386-397. doi: 10.1007/s00540-024-03325-5. Epub 2024 Mar 28.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to measure diaphragmatic dysfunction with ultrasonography and nerve stimulation of the phrenicus nerve, in patients undergoing thoracic surgery for lung and esophageal cancer, and correlate measures of diaphramatic function to clinical postoperative endpoints.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients scheduled for resection surgeries for either lung or esophagus cancer.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled thoracic resection Surgery for lung- or esophagus cancer. For lung cancer patients, at least one lung lobe has to scheduled for resection\n\nExclusion Criteria:\n\n* Known Diaphragmatic Dysfunction\n* Neuromuscular Disease\n* Pleural Effusion \\> 1cm\n* Pneumothorax\n* Known Phrenic Nerve Palsy'}, 'identificationModule': {'nctId': 'NCT04507594', 'briefTitle': 'Measurement of Diaphragmatic Dysfunction After Thoracic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Measurement of Diaphragmatic Dysfunction in Patients Undergoing Thoracic Resection Surgery for Lung- or Esophageal Cancer', 'orgStudyIdInfo': {'id': 'DiaphragmaticDysfunction'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing Thoracic Surgery', 'interventionNames': ['Procedure: Lung lobectomy OR esophagus cancer resection']}], 'interventions': [{'name': 'Lung lobectomy OR esophagus cancer resection', 'type': 'PROCEDURE', 'description': 'Lunge lobectomy (total) Resection of esophagus cancer', 'armGroupLabels': ['Patients undergoing Thoracic Surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Department of Anaesthesiology and Intensive Care East Section, Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aarhus University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Peter Juhl-Olsen', 'investigatorAffiliation': 'Aarhus University Hospital'}}}}