Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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) .
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional nasal oxygen therapy (COT) group (35 patients) | Active Comparator | Who will receive 5 L/min oxygen flow through standard nasal cannula (gives FiO2 of about 0.4). The allocated flow rates will be maintained throughout the procedure unless intervention will be required at the discretion of the anesthesiologist in charge of the case. |
|
| High-flow nasal cannula (HFNC) group (35 patients) | Active Comparator | Who will receive 30 L/min oxygen flow through VapothermR Precision Flow HFNC. The fraction of inspired Oxygen (FiO2) will be adjusted at 0.4, temperature at 37â—¦C with 100% humidity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-flow nasal cannula (HFNC) | Device | high flow cartridge and adult size nasal cannula: (flow range: 5-40L/minute, oxygen concentration (FiO2): 21-100%, temperature range: 33-39â—¦ C, humidity minimum of 12mg/liter) |
| Measure | Description | Time Frame |
|---|---|---|
| Any occurrence of at least moderate hypoxemia of any duration measured by pulse oximetry during the procedure. | moderate hypoxemia, defined as SpO2 < 90% | During the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| The median lowest SpO2 | Measured by pulse oximetry during the procedure | During the procedure |
| Any episode of hypoxia occurring less than 1 minute, from 1 to 5 minutes, or more than 5 minutes | Hypoxemia may be: mild (SpO2 90%-94%), moderate (SpO2 76%-89%), severe (SpO2 ≤ 75%) |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopy procedure time | The duration of time the endoscope entered until exited the oral orifice. | During the procedure |
| Anesthetic time | The duration of time during which intravenous sedation with propofol will be administered. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ahmed M Mohamed, MD | Ain Shames University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University-Faculty of Medicine | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40110237 | Derived | Mohamed AM, Selima WZ. HFNC Oxygen Therapy vs COT in Prolonged Upper Gastrointestinal Endoscopy Inside the ICU: A Prospective, Randomized, Controlled Clinical Study. Indian J Crit Care Med. 2025 Mar;29(3):223-229. doi: 10.5005/jp-journals-10071-24919. Epub 2025 Feb 28. |
Not provided
Not provided
The statistics methods and results data will be shared after completing the study
Not provided
Not provided
Not provided
Not provided
Not provided
A prospective, randomized, comparative, controlled clinical trial study
Not provided
Not provided
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.
|
| Conventional nasal oxygen therapy (COT) | Device | Adult size, single use nasal cannula |
|
|
| Upper gastrointestinal endoscopy (UGE) including gastroscopy | Device | 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. |
|
|
| Upper gastrointestinal endoscopy (UGE) including Endoscopic ultrasound (EUA) | Device | Upper gastrointestinal endoscopy (UGE) will be diagnostic |
|
|
| During the procedure |
| Clinically significant hypoxia | 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 | During the procedure |
| Sedation related adverse effects (SRAEs) | They include hypotension, bradycardia, tachycardia, dysrhythmia, seizure, cardiac arrest, nausea or vomiting, recovery agitation, and delayed recovery | During the procedure and immediately after the procedure for 6 hours |
| Procedure-related adverse events (PRAEs) | 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. 2. Post-procedure adverse events as abdominal pain, bloating or bleeding, throat dryness, headache,gastrointestinal bleeding requiring intervention or perforation. | During the procedure and immediately after the procedure for 24 hours |
| Propofol total used doses in milligrams (mgs) | Propofol total used doses during sedation | During the procedure |
| During the procedure |
| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| D019160 | Endosonography |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
Not provided
Not provided