Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT05972304
Status:
COMPLETED
Last Update Posted:
2023-08-02
First Post:
2022-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006935', 'term': 'Hypercapnia'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-01', 'studyFirstSubmitDate': '2022-12-29', 'studyFirstSubmitQcDate': '2023-08-01', 'lastUpdatePostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Hypoxia ( SpO2 < 90%, lasting longer than 10 seconds) during the endoscopic procedure', 'timeFrame': 'During endoscopic procedure'}, {'measure': 'Incidence of severe Hypoxia ( SpO2 < 80%, lasting longer than 10 seconds) during the endoscopic procedure', 'timeFrame': 'During endoscopic procedure'}], 'secondaryOutcomes': [{'measure': 'Difference of delta tcpCO2 (transcutaneous pCO2) levels between two groups', 'timeFrame': 'During endoscopic procedure', 'description': 'Delta tcpCO2 is the difference of tpCO2 values from the beginning of the intervention to the mean tpCO2 levels observed throughout the procedure, between two groups'}, {'measure': 'Number of desaturation episodes (SpO2 < 90%)', 'timeFrame': 'During endoscopic procedure'}, {'measure': 'Interception of the intervention due to insufficient oxygenation', 'timeFrame': 'During endoscopic procedure'}, {'measure': 'The emmergence of serious adverse events', 'timeFrame': 'During endoscopic procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypercapnia', 'Hypoxia']}, 'descriptionModule': {'briefSummary': 'Goal of our study is to investigate whether the implication of nasal positive airway pressure (nPAP) system on patients with high periprocedural risk could significantly lower the incidence of severe hypoxia and hypercarbia. Furthermore, we have set up goals to assess key components and factors, which lead to development of hypercarbia during endoscopy.', 'detailedDescription': 'Sedation of high-risk patients resemble a relevant issue in interventional endoscopy.\n\nThis especially because standard oximetric monitoring displays only hypoxia and not the preceding hypercapnia. Therefore, the question arises whether the implication of a nasal positive airway pressure (nPAP) system can decrease the rate of sedation associated events.\n\nThe Null Hypothesis: The incidence of hypoxia in interventional group, using nasal positive airway pressure system, in comparison to control group with conventional oxygen supplementation canula is not significant.\n\nAlternative Hypothesis: The incidence of hypoxia in interventional group, using nasal positive airway pressure system is significantly lower, than in a control group with conventional oxygen supplementation canula'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA III (poorly controlled Diabetes Melitus (DM) or arterial hypertension (HTN), Chronic obstructive Pulmonary Disease (COPD), morbid obesity (BMI≥40), active hepatitis, alcohol dependence or abuse, implanted pacemaker, moderate reduction of ejection fraction, End Stage Renal Disease (ESRD), Advanced Liver Disease ( ACLD) ; history (\\>3 months) of Myocardial Infarction, coronary artery disease (CAD) , transient ischemic attack (TIA), or CAD/stents)\n* ASA IV (recent (\\<3 months MI, CVA, TIA, or CAD/stents, ongoing cardiac ischemia or severe valve dysfunction, severe reduction of ejection fraction, sepsis, ARD or ESRD not undergoing regularly scheduled dialysis\n* Active Malignancy (ECOG Performance \\>2)\n\nExclusion Criteria:\n\n* Patients with tracheotomy\n* Pregnancy\n* Intubation assisted endoscopy\n* Procedure without sedation'}, 'identificationModule': {'nctId': 'NCT05972304', 'acronym': 'Endo-Breath', 'briefTitle': 'Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Efficiency and Safety of Nasal Positive Airway Pressure Systems During Endoscopic Procedures in High Risk Patients. Endo-Breath-Study', 'orgStudyIdInfo': {'id': 'EndoBreath'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'Patients undergoing endoscopic procedures receiving oxygen supplementation through nasal positive airway pressure system ( 10 litters/minute).', 'interventionNames': ['Device: Nasal positive airway System by Vyaire Medical']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Patients undergoing endoscopic procedures receiving conventional oxygen supplementation through nasal cannula (6 litters/minute).'}], 'interventions': [{'name': 'Nasal positive airway System by Vyaire Medical', 'type': 'DEVICE', 'otherNames': ['Superno2Va', 'Radiometer TCM 5'], 'description': 'Incidence of Hypercarbia and Hypoxia in interventional group and its monitoring using transcutaneous (SpO2) and (tCO2) Sensor', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Benjamin Walter', 'investigatorFullName': 'Thomas Seufferlein', 'investigatorAffiliation': 'University of Ulm'}}}}