Ain Shams University-Faculty of Medicine
Cairo, Egypt
NCT Number: NCT06350864
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) .
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Notify Me20 year–60 year
All sexes
Interventional
Not applicable
Cairo, Egypt
Study will be conducted in the intensive care units (ICU) of Ain Shams University Hospitals, Cairo, Egypt. Consented and enrolled seventy patients will be randomly assigned to one of the following two groups:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
high flow cartridge and adult size nasal cannula: (flow range: 5-40L/minute, oxygen concentration (FiO2): 21-100%, temperature range: 33-39◦ C, humidity minimum of 12mg/liter)
Other names: Vapotherm Precision Flow HI-VNI Technology device
Adult size, single use nasal cannula
Other names: Ultramed
Upper gastrointestinal endoscopy (UGE) will be either diagnostic and/or therapeutic including variceal band ligation, endoscopic hemostasis as injection of bleeding peptic ulcers with adrenaline or bleeders control via either argon plasma coagulation (APC) or heater probe coagulation.
Other names: Pentax Medical 90k series gastroscopy with EPK-P High Resolution Video Process with endoscopic ultrasound (EUS).
Upper gastrointestinal endoscopy (UGE) will be diagnostic
Other names: Pentax Medical 90k series gastroscopy with EPK-P High Resolution Video Process with endoscopic ultrasound (EUS).
Time frame: During the procedure.
moderate hypoxemia, defined as SpO2 < 90%
Time frame: During the procedure
Measured by pulse oximetry during the procedure
Time frame: During the procedure
Hypoxemia may be: mild (SpO2 90%-94%), moderate (SpO2 76%-89%), severe (SpO2 ≤ 75%)
Time frame: During the procedure
The need to maneuver the upper airway or to change the flow, Fio2 and/or method of oxygen delivery in response to an episode of hypoxia
Time frame: During the procedure and immediately after the procedure for 6 hours
They include hypotension, bradycardia, tachycardia, dysrhythmia, seizure, cardiac arrest, nausea or vomiting, recovery agitation, and delayed recovery
Time frame: During the procedure and immediately after the procedure for 24 hours
They include :1. Intra-procedural adverse events: The need to pause or stop the procedure because of an episode of hypoxia, gastrointestinal bleeding requiring intervention or perforation.
Time frame: During the procedure
Propofol total used doses during sedation
Time frame: During the procedure
The duration of time the endoscope entered until exited the oral orifice.
Time frame: During the procedure
The duration of time during which intravenous sedation with propofol will be administered.
Ain Shams University
Other
High-flow Nasal Cannula (HFNC) Oxygen Therapy Versus Conventional Nasal Oxygen Therapy (COT) in Prolonged Upper Gastrointestinal (UGI) Endoscopy Inside the Intensive Care Unit (ICU): a Prospective, Randomized, Controlled Clinical Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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