Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 11:12 PM
Study NCT ID:
NCT01120951
Status:
COMPLETED
Last Update Posted:
2010-05-18
First Post:
2010-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Assessment of the Use of the R8 Respiratory Rate Counter in Post-Operative Recovery in Adults and Adolescents
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': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-17', 'studyFirstSubmitDate': '2010-05-09', 'studyFirstSubmitQcDate': '2010-05-09', 'lastUpdatePostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Respiratory rate R8 Anaxsys'], 'conditions': ['Respiratory Rate Changes']}, 'descriptionModule': {'briefSummary': 'The study aims to to establish whether or not measurement of respiratory rate taken using the Anaxsys Technology Ltd Respiratory Counter (R8 Counter) are equivalent to manual respiratory rate counting methods in patients receiving oxygen via a face mask.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female patients aged 12 years and above following elective surgery under general anaesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged 12 years and above following elective surgery under general anaesthesia\n\nExclusion Criteria:\n\n* Patients admitted for emergency surgery\n* Patients having ASA rating of 3 or greater\n* Patients not receiving general anaesthesia\n* Patients expected to be in post-operative recovery for less than 15 minutes'}, 'identificationModule': {'nctId': 'NCT01120951', 'briefTitle': 'Clinical Assessment of the Use of the R8 Respiratory Rate Counter in Post-Operative Recovery in Adults and Adolescents', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anaxsys Technology Ltd'}, 'officialTitle': 'Clinical Assessment of the Use of the R8 Respiratory Rate Counter in Post-Operative Recovery in Adults and Adolescents', 'orgStudyIdInfo': {'id': 'ATL01009'}}, 'contactsLocationsModule': {'locations': [{'zip': 'CB23 3RE', 'city': 'Cambridge', 'state': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'Papworth Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'state': 'Staffordshire', 'country': 'United Kingdom', 'facility': 'University Hospital of North Staffordshire', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}, {'zip': 'KT16 0PZ', 'city': 'Guildford', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': "St. Peter's and Ashford Hospital NHS Trust", 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'DY1 2HQ', 'city': 'Dudley', 'state': 'West Midlands', 'country': 'United Kingdom', 'facility': 'Russells Hall Hospital', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anaxsys Technology Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Dr Ian Smith', 'oldOrganization': 'Directorate of Anaesthesia, University Hospital of North Staffordshire, UK'}}}}