Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-29 @ 7:07 PM
Study NCT ID:
NCT01191528
Status:
COMPLETED
Last Update Posted:
2010-12-13
First Post:
2010-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index (IPI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004892', 'term': 'Erythema Multiforme'}], 'ancestors': [{'id': 'D004890', 'term': 'Erythema'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-10', 'studyFirstSubmitDate': '2010-08-30', 'studyFirstSubmitQcDate': '2010-08-30', 'lastUpdatePostDateStruct': {'date': '2010-12-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adult', 'Post', 'operative', 'oximetry', 'capnometry', 'Integrated', 'Pulmonary', 'Index', 'End-tidal', 'Monitoring Respiratory status', 'post-operative'], 'conditions': ['Postoperative Care']}, 'descriptionModule': {'briefSummary': 'To compare two ways to test breathing after surgery in acute care setting. One method tests oxygen level of the blood, and one method will test oxygen and the carbon dioxide that is breathed out.', 'detailedDescription': 'A simple comparison design will be used to compare pulse SpO2 monitoring of respiratory status to a combination of pulse SpO2 monitoring and EtCO2 nasal cannula monitoring with Integrated Pulmonary Index (IPI). Using combination monitor, each subject will serve as their own control with repeated measurements of respiratory rate, SpO2, EtCO2 and IPI at 5 second intervals. Patients will be monitored for a minimum of 8 hours after admission to the acute care unit and through the first night.\n\nSubjects for this study will be a convenience sample post-operative in-patients admitted to 2 East after surgery at Allenmore Hospital/Multicare Health System a 75 bed community facility.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Convenience sample post-operative in-patients admitted to 2 East at Allenmore Hospital/multicare Health system a 75 bed community facility.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age greater than 18\n* Increased Body Mass Index (BMI) \\> 31\n* History of chronic obstructive pulmonary disease (COPD)\n* History of Sleep Apnea\n\nExclusion criteria:\n\n* Respiratory failure\n* Isolation requirements\n* Surgical patients admitted to 2 West or ICU'}, 'identificationModule': {'nctId': 'NCT01191528', 'briefTitle': 'The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index (IPI)', 'organization': {'class': 'OTHER', 'fullName': 'Allenmore Hospital'}, 'officialTitle': 'The Comparison of Pulse Oximetry, End-tidal Capnometry, and Integrated Pulmonary Index in Adult Post-operative Patients', 'orgStudyIdInfo': {'id': 'AH2ESCAP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'capnostream 20, Oridian Medical 1987 ltd, Needham MA', 'type': 'DEVICE', 'otherNames': ['OxiMax Nellcor, Covidien, Capnoline, Oridion Medical'], 'description': 'Oxygen blood saturation measured by a s sensor that reflects infrared light on oxygenated and deoxygenated arterial blood via a noninvasive, clip on digit sensor connected to a combination capnometer and pulse oximeter monitor.\n\nEnd-tidal Carbon dioxide (EtCO2) is measured with a noninvasive nasal cannula sampling line which calculates the EtCO2 from exhaled air. Measurements recorded at 5 second intervals.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98411', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Allenmore Hospital', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Julie M Northrup, ADN, BC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multicare Health System-Allenmore Hospital'}, {'name': 'Jennifer Spotted-Horse, MS,BSN,OCN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multicare Health System-Allenmore Hospital'}, {'name': 'Dawn Fox, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multicare Health System-Allenmore Hosptial'}, {'name': 'David Lechich, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multicare Health System-Allenmore Hospital'}, {'name': 'Joan Fortune, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multicare Health System Allenmore Hospital'}, {'name': 'Katy Rogers, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multicare Health System, Allenmore Hospital'}, {'name': 'Lynn Arnold, RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multicare Health System Allenmore Hospital'}, {'name': 'Lisa Ettlin-Porter, BSN,RN,CCRN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multicare Health System Allenmore Hospital'}, {'name': 'Dee Harris, BS,RRT,RPFT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Multicare Health System Allenmore Hospital'}, {'name': 'Colleen Doherty, PhD(c),RN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Consultant-Multicare Health System Allenmore Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allenmore Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Julie Northrup RN, BC', 'oldOrganization': 'Multicare Health System Allenmore Hospital'}}}}