Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-04-17 @ 11:11 PM
Study NCT ID:
NCT02036034
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2011-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-11', 'studyFirstSubmitDate': '2011-08-15', 'studyFirstSubmitQcDate': '2014-01-11', 'lastUpdatePostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'transcutaneous CO2 level in mmHg under surgical drape with forced air warmer', 'timeFrame': '10 minutes, 15 minutes, 30 minutes', 'description': 'baseline transcutanoeus CO2 level will be taken before surgical draping. After draping, CO2 level will be measured with transcutaneous CO2 frome earlobe at 10 minutes, 15 minutes, and 30 minutes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['To Prevent Hypercarbia Under the Opthalmology Drape During Surgery.', 'To Prevent Hypothermia During Opthalmology Surgery.']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that this modified ophthalmic draping will reduce the accumulation and rebreathing of carbon dioxide during eye surgery.', 'detailedDescription': "Majority of eye surgery has been widely done under local anesthesia provided by the ophthalmologist with or without sedation.The surgical drapes used often covers the patients face and beyond in order to maintain sterility of the surgical field. This can lead to accumulation of carbon dioxide under ophthalmic drapes due to the exhaled carbon dioxide escapes incompletely through the drapes;hence results in an increase of carbon dioxide in the ambient air surrounding the patient's head.This causes an increase in arterial carbon dioxide partial pressure and thus hyperventilation and patient discomfort with restlessness and unable to stay still during the surgery.\n\nIn recent years,several types of ophthalmic drapes have been produced.This study is look for possible difference in accumulation of carbon dioxide under the standard ophthalmic drapes compared to the modified draping."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- ASA physical status I,II OR III,adult aged 40 to 80 years old,scheduled to undergo elective eye surgery under local anaesthetic at UMMC will be enrolled in this study.\n\nExclusion Criteria:\n\n* Pre-existing pulmonary disease,psychological disorders,neurological disorder and patient required sedation.'}, 'identificationModule': {'nctId': 'NCT02036034', 'briefTitle': 'Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Effectiveness of Modified Ophthalmic Draping Method in Preventing Carbon Dioxide Accumulation in Patient Undergoing Eye Surgery Under Local Anesthesia', 'orgStudyIdInfo': {'id': 'eyedrapCO2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'drape with forced air warmer', 'description': 'forced air warmer placed under the chin before draping, inflated after draping completed.', 'interventionNames': ['Device: forced air warmer (Bair Hugger)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'drape with warming blanket', 'description': 'warming blanket placed on torso of patient under the drape.', 'interventionNames': ['Device: warming blanket']}], 'interventions': [{'name': 'forced air warmer (Bair Hugger)', 'type': 'DEVICE', 'otherNames': ['Forced air warmer brand - Bair Hugger'], 'description': 'forced air warmer placed under the chin before draping, forced air warmer inflated after draping is completed.', 'armGroupLabels': ['drape with forced air warmer']}, {'name': 'warming blanket', 'type': 'DEVICE', 'otherNames': ['warming blanket brand - Thermamed warming system'], 'description': 'warming blanket placed on torso of patient under the drape.', 'armGroupLabels': ['drape with warming blanket']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'state': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Center', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'overallOfficials': [{'name': 'Siaw Boon Tan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Malaya'}, {'name': 'sukhcharanjit S Singh', 'role': 'STUDY_CHAIR', 'affiliation': 'Universiti Malaya'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Alvin Tan Siaw Boon', 'investigatorAffiliation': 'University of Malaya'}}}}