Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05793658
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2023-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Respiratory Rate Derived From Capnography in Sedated Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2023-02-28', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoxemia', 'timeFrame': '1 hours', 'description': 'Detected by pulse oximeter'}], 'secondaryOutcomes': [{'measure': 'Patient movements during the procedure', 'timeFrame': '1 hour', 'description': 'Measured by questionnaire to the gastroenterologist (scale from 1 to 5)'}, {'measure': 'Effort exerted by the anesthesiologist ( the provider)', 'timeFrame': '1 hour', 'description': 'Measured by questionnaire ( scale from 1 to 5 )'}, {'measure': 'Patient satisfaction', 'timeFrame': '1 hour', 'description': 'Measured by questionnaire ( scale from 1 to 5 )'}, {'measure': 'Gastroenterologist satisfaction', 'timeFrame': '1 hour', 'description': 'Measured by questionnaire ( scale from 1 to 5 )'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sedation', 'capnography', 'Respiratory rate', 'colonoscopy'], 'conditions': ['Sedation Problems']}, 'descriptionModule': {'briefSummary': 'Although appropriate sedation is recommended during colonoscopy, patients are at risk for adverse events e.g hypoventilation and hypoxemia due to inadvertent oversedation. The aim of this study was to evaluate the benefit of additional quantitative capnography monitoring ( respiratory rate )in management of patient undergoing colonoscopy under sedation in preventing or reducing the incidence of adverse events and also determine when to start the procedure and when to give and not to give increments of sedative drugs during the procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA 1 and 2 adult patients\n* Age from 20 to 50 years old\n* elective colonoscopy\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) above Class II\n* History of psychiatric or neurological disease'}, 'identificationModule': {'nctId': 'NCT05793658', 'briefTitle': 'Role of Respiratory Rate Derived From Capnography in Sedated Patients', 'organization': {'class': 'OTHER', 'fullName': 'Al Jedaani Hospital'}, 'officialTitle': 'Is Respiratory Rate Derived From Capnography Can Prevent Adverse Events Occurred in Sedated Patients.', 'orgStudyIdInfo': {'id': '1/5/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sedation with standard capnography', 'description': '37 patient Sedation using midazolam + propofol for colonoscopy', 'interventionNames': ['Procedure: Standard capnography']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sedation with modified capnography', 'description': '37 patients in Sedation using midazolam + fentanyl + propofol for colonoscopy', 'interventionNames': ['Procedure: Modified capnography']}], 'interventions': [{'name': 'Standard capnography', 'type': 'PROCEDURE', 'otherNames': ['Qualitative capnograpyhy'], 'description': 'Patients undergoing colonoscopy under sedation were randomly assigned to receive standard capnography monitoring or modified capnography monitoring which can be achieved by tucking capnography probe under the face mask.74 patients were enrolled. Patient characteristics were well balanced between the two groups 37 patients in each group.', 'armGroupLabels': ['Sedation with standard capnography']}, {'name': 'Modified capnography', 'type': 'PROCEDURE', 'otherNames': ['Quantitative capnography'], 'description': "If Respiratory rate below 14 b/m: more sedation isn't not advised and the patient may develop airway obstruction and needs airway intervention ( like jaw thrust or oral airway) If respiratory rate more than 20 b/m it means this patient is prone to awake or to move and this patient in need for incremental dose of sedative drug ( e.g 20 to 30 mg propofol) Also roughly speaking respiratory rate from 16 to 18 b/m is the target", 'armGroupLabels': ['Sedation with modified capnography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21462/7500', 'city': 'Jeddah', 'state': 'Meccah', 'country': 'Saudi Arabia', 'facility': 'Al Jedaani group of hospitals', 'geoPoint': {'lat': 21.49012, 'lon': 39.18624}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al Jedaani Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}