Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT01371903
Status:
COMPLETED
Last Update Posted:
2014-03-24
First Post:
2011-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Patient Features on Opioid Induced End-Tidal CO2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-20', 'studyFirstSubmitDate': '2011-06-10', 'studyFirstSubmitQcDate': '2011-06-10', 'lastUpdatePostDateStruct': {'date': '2014-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'end tidal carbon dioxide', 'timeFrame': 'study start, 30 minutes, 60 minutes, 90 minutes, 120 minutes', 'description': 'measured through small nasal cannula (plastic tube at base of nares)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['morphine', 'fentanyl', 'dilaudid', 'opioid', 'capnography'], 'conditions': ['Opioid Use During Medical Care']}, 'descriptionModule': {'briefSummary': 'Emergency department patients receiving opioid pain medicine such as morphine, fentanyl or Dilaudid are eligible. After medication exhaled carbon dioxide is measured. and recorded.', 'detailedDescription': 'Emergency department patients receiving opioid pain medicine such as morphine, fentanyl, or Dilaudid are eligible. After receiving the pain medication, a small soft plastic tube will be placed between the upper lip and nose. This tube is used to measure the amount of carbon dioxide the patient is breathing out. It can also be used to deliver oxygen if the provider feels the patient needs it. The carbon dioxide breathed out is measured and collected. Other information collected are height, weight, and vital signs. Patient participation time is approximately 2 hours during the emergency department visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving opioid such as morphine, fentanyl, or dilaudid during their emergency department visit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non intubated patients receiving intravenous opioid medications\n\nExclusion Criteria:\n\n* mechanically ventilated patients\n* patients with physiologic shock'}, 'identificationModule': {'nctId': 'NCT01371903', 'acronym': 'Capno', 'briefTitle': 'The Effects of Patient Features on Opioid Induced End-Tidal CO2', 'organization': {'class': 'OTHER', 'fullName': 'Albany Medical College'}, 'officialTitle': 'The Effect of Patient Features on Opioid Induced End-Tidal CO2', 'orgStudyIdInfo': {'id': '2792'}}, 'contactsLocationsModule': {'locations': [{'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center Emergency Department', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albany Medical College', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Emergency Medicine', 'investigatorFullName': 'Wayne Triner', 'investigatorAffiliation': 'Albany Medical College'}}}}