Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 9:14 PM
Study NCT ID:
NCT07489157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Real-Time End-Tidal Carbon Dioxide Monitoring for Early Warning of Hypoxemia in Painless Gastrointestinal Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 460}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-27', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-19', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of hypoxemia', 'timeFrame': 'During gastrointestinal endoscopy', 'description': 'Incidence of SpO₂ \\< 95%(%)'}, {'measure': 'Duration of hypoxemia', 'timeFrame': 'During gastrointestinal endoscopy', 'description': 'Duration of of SpO₂ \\< 95%(seconds)'}], 'secondaryOutcomes': [{'measure': 'Incidence of movement', 'timeFrame': 'during gastrointestinal endoscopy', 'description': 'Incidence of movement(%)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypoxemia', 'End-Tidal Carbon Dioxide Monitoring', 'Gastrointestinal Endoscopy', 'Painless'], 'conditions': ['Hypoxemia']}, 'referencesModule': {'references': [{'pmid': '32925318', 'type': 'RESULT', 'citation': 'Khanna AK, Bergese SD, Jungquist CR, Morimatsu H, Uezono S, Lee S, Ti LK, Urman RD, McIntyre R Jr, Tornero C, Dahan A, Saager L, Weingarten TN, Wittmann M, Auckley D, Brazzi L, Le Guen M, Soto R, Schramm F, Ayad S, Kaw R, Di Stefano P, Sessler DI, Uribe A, Moll V, Dempsey SJ, Buhre W, Overdyk FJ; PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY (PRODIGY) Group Collaborators. Prediction of Opioid-Induced Respiratory Depression on Inpatient Wards Using Continuous Capnography and Oximetry: An International Prospective, Observational Trial. Anesth Analg. 2020 Oct;131(4):1012-1024. doi: 10.1213/ANE.0000000000004788.'}, {'pmid': '33905213', 'type': 'RESULT', 'citation': 'Bisschops R, Saunders R, Dooms C, Hoffman I, van der Merwe S, Weissbrod R, Torres RT, Van Assche G, Demedts I. Implementing capnography to help improve patient safety during procedural sedation: quality improvement in a high-volume gastroenterology department. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e522-e528. doi: 10.1097/MEG.0000000000002144.'}]}, 'descriptionModule': {'briefSummary': "Using Capnography for Safer Sedation in Painless Gastrointestinal Endoscopy\n\nWhy is this study important? For procedures like painless gastroscopy and colonoscopy, patients receive sedation to ensure comfort. However, traditional monitoring (like checking heart rate and blood oxygen levels) can only detect breathing problems after they have already caused a drop in oxygen. This delay can be risky, especially for elderly patients whose breathing function is naturally weaker. This study looks at a better way to monitor patients.\n\nWhat is the new method? This study focuses on a technology called real-time end-tidal carbon dioxide (ETCO₂) monitoring, also known as capnography. It is a simple, non-invasive device that continuously measures the carbon dioxide a patient breathes out. This provides an early warning system for doctors, alerting them to breathing issues (like a pause in breathing or an airway blockage) much sooner than traditional monitors can.\n\nWhat did the study find?\n\nBased on extensive research and clinical experience both in China and internationally (including the US and Europe), integrating ETCO₂ monitoring into painless digestive endoscopy procedures leads to significant improvements in patient safety:\n\n* Reduces Risks: It can decrease the occurrence of hypoxemia (dangerously low oxygen levels) by up to 31%.\n* Early Detection: It detects breathing problems 17.6 times more often than relying on traditional observation alone, giving anesthesiologists crucial extra time (often seconds) to intervene before a patient's oxygen drops.\n* Safer for Everyone: It is particularly effective in protecting high-risk groups, such as elderly patients and those with mild obesity.\n* Better Outcomes: It helps reduce postoperative complications like nausea and vomiting, and can lead to faster recovery from anesthesia.\n\nValue for Patients, Families, and Providers:\n\n* For Patients \\& Families: This technology means a safer, more comfortable procedure with a lower risk of breathing complications. It provides peace of mind knowing your breathing is being watched continuously and carefully.\n* For Healthcare Providers: It offers a clear, real-time picture of a patient's breathing status. This supports quicker, more confident clinical decisions, reduces workload, and helps establish a standardized, quantifiable safety protocol for non-operating room anesthesia, aligning with the World Health Organization's goals for safer surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing gastroscopy and colonoscopy under intravenous anesthesia\n\nExclusion Criteria:\n\n* (Ⅰ) patients unable to wear the sampling device; (Ⅱ) patients with a pulse oximetry reading (SpO2) of less than 95% when breathing ambient air;(Ⅲ)central nervous system abnormalities; (Ⅳ)patients who do not consent to participate in the study;(Ⅴ)poor bowel preparation.'}, 'identificationModule': {'nctId': 'NCT07489157', 'briefTitle': 'Real-Time End-Tidal Carbon Dioxide Monitoring for Early Warning of Hypoxemia in Painless Gastrointestinal Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Application of Real-Time End-Tidal Carbon Dioxide Monitoring in Painless Gastrointestinal Endoscopy', 'orgStudyIdInfo': {'id': 'PLAGH-L04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group C', 'description': 'The patient was positioned in the left lateral decubitus position, with oxygen being administered via nasal cannula at a rate of 2 liters per minute(2L/min). End-tidal carbon dioxide (ETCO2) was collected using a microstream capnography nasal sampling tube. Both groups of patients wore nasal cannulas for end-tidal carbon dioxide monitoring. the control group (C group) had the capnograph monitor screen obscured and the machine sound muted.'}, {'type': 'EXPERIMENTAL', 'label': 'Group T', 'description': 'The patient was positioned in the left lateral decubitus position, with oxygen being administered via nasal cannula at a rate of 2 liters per minute(2L/min). End-tidal carbon dioxide (ETCO2) was collected using a microstream capnography nasal sampling tube. Both groups of patients wore nasal cannulas for end-tidal carbon dioxide monitoring. The observation group (T group) viewed the capnograph monitor (Capnostream 20P Patient Monitor, Medtronic Inc., Minnesota, Minneapolis, USA), screen and heard the initiation sound of the machine.', 'interventionNames': ['Device: a microstream capnography nasal end-tidal carbon dioxide sampling tube']}], 'interventions': [{'name': 'a microstream capnography nasal end-tidal carbon dioxide sampling tube', 'type': 'DEVICE', 'description': 'In addition to routine monitoring (ECG, NIBP, and SpO2), a microstream capnography nasal end-tidal carbon dioxide sampling tube is used for end-tidal carbon dioxide capnography monitoring.', 'armGroupLabels': ['Group T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Peiqi Wang, PhD', 'role': 'CONTACT', 'email': 'qiqi218@sina.com', 'phone': '86+13141307586'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Peiqi Wang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}