Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-29 @ 11:15 AM
Study NCT ID:
NCT04506203
Status:
COMPLETED
Last Update Posted:
2023-08-14
First Post:
2020-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001261', 'term': 'Pulmonary Atelectasis'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Lung Collapse will be diagnosed by a blind researcher that does not know the air test results'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-07', 'studyFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2020-08-06', 'lastUpdatePostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atelectasis incidence', 'timeFrame': '5 minutes', 'description': 'Assess incidence of SpO2 \\< 97% 15 minutes after anesthesia induction during a 5 minutes long air test (FiO2 \\< 0.25).'}, {'measure': 'Accuracy of Pediatric Air test trial', 'timeFrame': '5 minutes', 'description': 'Assess incidence of lung collapse (hence atelectasis incidence) 15 minutes after anesthesia induction using an air test (FiO2 \\< 0.25). Collapse blind validation using lung US'}], 'secondaryOutcomes': [{'measure': 'Atelectasis risk factors assessment', 'timeFrame': '5 minutes', 'description': 'Determine if there occurs higher atelectasis incidence depending on age, sex, medical records, body weight index or type of surgery'}, {'measure': 'Atelectasis severity', 'timeFrame': '5 minutes', 'description': 'Determine if there is any correlation between SpO2 values during air test and lung collapse, graded upon a validated severity lung collapse image score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['air test', 'atelectasis', 'pediatric', 'non-invasive', 'lung collapse'], 'conditions': ['Lung Collapse', 'Lung Diseases', 'Atelectasis', 'Atelectasis Without Respiratory Distress Syndrome', 'Atelectases, Resorption', 'Air Test', 'Pediatric Disorder']}, 'descriptionModule': {'briefSummary': 'HYPOTHESIS:\n\nDuring anesthetic pre-oxygenation with high FiO2, pulmonary atelectasis occur, especially in patients \\< 6 years old, where FRC and pulmonary closing volume may overlap. New borns and children \\<1 year old are especially vulnerable.\n\nOBJECTIVES:\n\n1. Validate "air test" as a individualized and non-invasive diagnostic method of clinically significant atelectasis in pediatrics.\n2. Determine what other factors contribute to atelectasis development in pediatrics\n\nMETHODS:\n\n30 pediatric patients will be studied with ages ranged between 45 postconceptional weeks and16 years old.\n\nBaseline SpO2 and lung ultrasound will be performed for each patient upon arrival at the operating theatre before preoxygenation with FiO2 of 1.0 SpO2 will be measured 15 min after intubation during a 5 min long "air test" trial (FiO2 0.25). lung collapse will be verified by lung ultrasound at the end of the 15 min trial. Lung collapse will be eventually granted upon lung US verification by a blind researcher.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General anesthesia\n* Perioperative risk classification (ASA) I, II, III\n* Newborns (postconceptional age\\> 45 weeks) to 16 years\n* Need for oral / nasotracheal intubation\n\nExclusion Criteria:\n\n* ASA \\> III\n* Basal SpO2 \\< 97% on air in supine position\n* Preoperative need for oxygen therapy and / or high-flow nasal cannulas\n* Expected Difficult airway\n* Presence of craniofacial disorders that may compromise ventilation\n* Hemodynamic instability and / or need for inotropics\n* History of untreated heart disease\n* Presence or history of pneumothorax\n* Presence of untreated congenital pulmonary disorders\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT04506203', 'briefTitle': 'The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario La Paz'}, 'officialTitle': 'The Accuracy of Pediatric Air Test as a Non-invasive Atelectasis Diagnostic Tool: a Multi-centre Prospective Double-blind Study', 'orgStudyIdInfo': {'id': 'HULaPaz'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Air test', 'interventionNames': ['Diagnostic Test: Air test']}], 'interventions': [{'name': 'Air test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients will breathe 0.21 \\< FiO2 \\< 0.25 during 5 min and have a lung ultrasound perfomed at the end of the 5 min trial.', 'armGroupLabels': ['Air test']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital Privado de Comunidad', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Upon publishment in journal', 'ipdSharing': 'YES', 'description': 'IPD will be published in a peer reviewed journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario La Paz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Universitario La Princesa', 'class': 'UNKNOWN'}, {'name': 'Hospital Privado de Comunidad', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Patricio Gonzalez Pizarro', 'investigatorAffiliation': 'Hospital Universitario La Paz'}}}}