Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT05384795
Status:
COMPLETED
Last Update Posted:
2023-04-05
First Post:
2022-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perioperative Atelectasis in Orthopaedic Surgery: a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-04', 'studyFirstSubmitDate': '2022-05-13', 'studyFirstSubmitQcDate': '2022-05-18', 'lastUpdatePostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung atelectasis score', 'timeFrame': 'immediately after the surgery', 'description': 'Atelectasis score based on validated ultrasound quantification (comparing different anesthesia techniques)'}], 'secondaryOutcomes': [{'measure': 'Lung atelectasis score', 'timeFrame': 'Four timepoints: at baseline, immediatly before surgery (after anesthesia induction), immediately after the surgery, and at the recovery room', 'description': 'Atelectasis score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atelectasis']}, 'descriptionModule': {'briefSummary': 'This study aims at comparing a perioperative pulmonary atelectasis score, measured by pulmonary ultrasound, in patients operated undergoing orthopedic surgery under general anesthesia, spinal anesthesia or peripheral nerve block. The association between the atelectasis score and previously identified risk factors will be studied.', 'detailedDescription': 'Atelectasis is one of the most common pulmonary complications in the perioperative period, occurring in 85% to 90% of patients under general anesthesia. It can be responsible for hypoxemia and be associated with postoperative pulmonary complications such as pneumonia. The consequences are a prolongation of the hospital stay and an increase in mortality.\n\nThe appearance of perioperative atelectasis is mainly secondary to the induction of general anesthesia with an incidence up to 90%. The different causes are, for example, the administration of muscle relaxants, mechanical ventilation and the position of the patient.\n\nIn orthopedic surgery, many procedures are performed under spinal anesthesia or under peripheral nerve block. At present, there are no studies measuring the incidence of atelectasis in patients operated under these two techniques of locoregional anesthesia, with the exception of parturients undergoing cesarean section.\n\nThis study aims at comparing a perioperative pulmonary atelectasis score, measured by pulmonary ultrasound, in patients operated undergoing orthopedic surgery under general anesthesia, spinal anesthesia or peripheral nerve block. The association between the atelectasis score and previously identified risk factors will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants will be patients scheduled for elective surgery at the Orthopedic Hospital from CHUV.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18;\n* Patients scheduled for an elective operation at the Orthopedic Hospital of CHUV;\n* Signature of the study consent\n\nExclusion Criteria:\n\n* Thoracic deformities preventing the performance of pulmonary ultrasound (dressings, drains, fractures, etc.);\n* Refusal to participate;\n* Patient does not speak French.\n* Inability to discern'}, 'identificationModule': {'nctId': 'NCT05384795', 'acronym': 'ATELHO', 'briefTitle': 'Perioperative Atelectasis in Orthopaedic Surgery: a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'Perioperative Atelectasis in Patients Undergoing Orthopaedic Surgery: Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'CER-VD 2022-00712'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'General anesthesia', 'interventionNames': ['Other: Lung ultrasound']}, {'label': 'Spinal anesthesia', 'interventionNames': ['Other: Lung ultrasound']}, {'label': 'Peripheral nerve block', 'interventionNames': ['Other: Lung ultrasound']}], 'interventions': [{'name': 'Lung ultrasound', 'type': 'OTHER', 'description': 'Lung atelectasis score', 'armGroupLabels': ['General anesthesia', 'Peripheral nerve block', 'Spinal anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1005', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Fully anonymised IPD will be shared upon reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eric Albrecht', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med', 'investigatorFullName': 'Eric Albrecht', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}