Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 3:05 PM
Study NCT ID:
NCT04139356
Status:
UNKNOWN
Last Update Posted:
2019-10-25
First Post:
2019-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Spontaneous Respiration on Pulse-oximetry Measurements
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Clinical experimental trial of changes in pulse-oxymetry measurements with deep inspirations'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 45}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-23', 'studyFirstSubmitDate': '2019-10-23', 'studyFirstSubmitQcDate': '2019-10-23', 'lastUpdatePostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in O2 saturation', 'timeFrame': 'Lenght of experimental protocol: 6 minutes.', 'description': 'A Saturation change greater than 4% will be considered significant'}], 'secondaryOutcomes': [{'measure': 'Vd/VT', 'timeFrame': 'Lenght of experimental protocol: 6 minutes.', 'description': 'In a subset of 13 patients with the greater increase on O2Sat, Vd/Vt will be measured during the same protocol'}, {'measure': 'Cardiac output (CO)', 'timeFrame': 'Lenght of experimental protocol: 6 minutes.', 'description': 'In a subset of 13 patients with the greater increase on O2Sat, CO will be measured during the same protocol'}, {'measure': 'CT recruitment', 'timeFrame': 'Lenght of experimental protocol: 6 minutes.', 'description': 'In a subset of 13 patients with the greater increase on O2Sat, CT recruitment will be calculated using densitometry values during the same protocol'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulseoxymetry', 'capnography', 'Dead space', 'cardiac output', 'lung recruitment', 'deep breaths'], 'conditions': ['Chronic Respiratory Disease', 'COPD', 'Interstitial Lung Disease']}, 'descriptionModule': {'briefSummary': 'This is a study designed to measure, characterize and describe changes on pulse-oxymetry values produced as a result of deep breaths in patients with stable chronic hypoxemic respiratory failure.', 'detailedDescription': 'There is no standard way of measuring rest pulse-oxymetry in terms of depth of respiration. Rest pulse-oxymetry values are used in the clinical setting to make therapeutic decisions regarding the need of supplemental oxygen. The primary goal of this study is to measure the change of pulse-oxymetry values during an experimental protocol of 10 deep breaths during one minute in patients with chronic hypoxemia. 45 patients will be studied in this first phase. In a second phase, secondary goals will be to measure Vd/Vt vent, noninvasive cardiac output and CT densitometry during the same deep breaths protocol in a subset of 13 patients with the grater increase observed in the first phase of study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic lung disease causing rest hypoxemia, with rest SpO2 values equal or lower than 94% on room air\n* Ambulatory patients capable of performing 6 min walking test\n* Patients older than 18 years old.\n\nExclusion Criteria:\n\n* Patients with significant collagen disease causing Raynaud phenomenon.\n* Patients with hypothermia lower than 35 degrees Celsius\n* Patients with rest SpO2 values equal or lower than 80% on room air\n* Patients unable to perform PFTs\n* Patients unable to complete 6 min walking test without supp O2.\n* Patients unable to perform experimental deep breaths on CT scan'}, 'identificationModule': {'nctId': 'NCT04139356', 'briefTitle': 'The Effect of Spontaneous Respiration on Pulse-oximetry Measurements', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de Nuevo Leon'}, 'officialTitle': 'The Effect of Spontaneous Respiration on Pulse-oximetry Measurements and Analysis of Variability Mechanisms', 'orgStudyIdInfo': {'id': 'UAutonomaNL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with rest O2 desaturation', 'description': 'Patient will undergo an experimental protocol consisting of 10 deep inspirations to measure and characterize changes on pulse-oxymetry values', 'interventionNames': ['Procedure: Deep breaths']}], 'interventions': [{'name': 'Deep breaths', 'type': 'PROCEDURE', 'description': 'Patients will undergo a 6 minutes protocol. Baseline: 1 minute normal breaths. Intervention: 1 minute with 10 deep breaths, 1 each 6 secs. Pulse-oxymetry will be continuously recorded.', 'armGroupLabels': ['Patients with rest O2 desaturation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64630', 'city': 'Monterrey', 'state': 'Nuevo León', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Uriel Chavarria, MD', 'role': 'CONTACT', 'email': 'uriel_chavarria@hotmail.com', 'phone': '+528183482018'}], 'facility': 'Facultad de Medicina y Hospital Universitario UANL', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}], 'centralContacts': [{'name': 'Uriel Chavarria, MD', 'role': 'CONTACT', 'email': 'uriel_chavarria@hotmail.com', 'phone': '+528183482018'}], 'overallOfficials': [{'name': 'Uriel Chavarria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Facultad de Medicina y Hospital Universitario UANL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de Nuevo Leon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Internal Medicine Pulmonary and Critical Care', 'investigatorFullName': 'Uriel Chavarria-Martinez', 'investigatorAffiliation': 'Universidad Autonoma de Nuevo Leon'}}}}