protocolSection identificationModule nctId: NCT06350864, orgStudyIdInfo id: FMASU R11/2024, briefTitle: HFNC Versus Conventional Oxygen Therapy in Prolonged Upper Gastrointestinal Endoscopy in the ICU, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-20, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Conventional supplemental oxygen therapy (COT) during upper gastrointestinal (UGI) endoscopy via nasal catheter is considered the standard practice in maintenance of oxygenation and prevention of hypoxia. However, it is still unclear if this oxygen delivery method is optimal in a prolonged (more than 15 minutes) procedure in patients admitted to the ICU. Because of shortage of data in this concern, this prospective, randomized, controlled clinical trial study will aim to evaluate and compare the efficacy of high-flow nasal cannula (HFNC) oxygen therapy versus COT in patients who will undergo prolonged either diagnostic or therapeutic UGI endoscopy in the intensive care unit (ICU) ., conditionsModule conditions: Upper Gastrointestinal Bleeding, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A prospective, randomized, comparative, controlled clinical trial study, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The patients and anesthesiologists in charge of the case will be unmasked as High-flow nasal cannula HFNC) shape,setting and preparation are completely different from the Conventional nasal oxygen therapy (COT), so masking both of them is impossible., whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: High-flow nasal cannula (HFNC), interventions name: Conventional nasal oxygen therapy (COT), interventions name: Upper gastrointestinal endoscopy (UGE) including gastroscopy, interventions name: Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA), outcomesModule primaryOutcomes measure: Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure., secondaryOutcomes measure: The median lowest SpO2 -Any episode of hypoxia -Clinically significant hypoxia -Sedation and procedure related adverse effects -Endoscopy procedure time -Anesthetic time -Propofol total used doses, secondaryOutcomes measure: Any episode of hypoxia occurring less than 1 minute, from 1 to 5 minutes, or more than 5 minutes, secondaryOutcomes measure: Clinically significant hypoxia, secondaryOutcomes measure: Sedation related adverse effects (SRAEs), secondaryOutcomes measure: Procedure-related adverse events (PRAEs), otherOutcomes measure: Endoscopy procedure time, otherOutcomes measure: Anesthetic time, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Ain Shams University-Faculty of Medicine, status: RECRUITING, city: Cairo, country: Egypt, contacts name: Ahmed M Mohamed, MD, role: CONTACT, phone: 002 01121318459, email: drahmed.mostafa.mohamed@med.asu.edu.eg, contacts name: Wessam Z Selima, MD, role: CONTACT, phone: 002 01001958858, email: w.z.selima@med.asu.edu.eg, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False