An observational study in Biliary Obstruction, Oddi's Sphincter Constriction and Biliary Stones, sponsored by Yunus Emre. Status unknown. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-06-27.
Sponsored by Yunus Emre · Observational
It is designed to monitor the efficacy of nasal cannula or hıgh-flow nasal oxygen in geriatric patients for endoscopıc retrograde cholangıopancreatography procedures. The aim of the study is to evaluate the efficacy and safety of oxygen support obtained with low-flow nasal cannula and hıgh-flow nasal oxygen during endoscopıc retrograde cholangıopancreatography in the patient group at risk for adverse respiratory events. We hypothesized that high-flow nasal oxygen administration can prevent adverse respiratory events such as deep sedation and patient position that may endanger the airway safety of patients, and reduce the problems in cardiac and hemodynamic parameters that may develop.
In this retroprospective study, it was aimed to compare the effects of high flow nasal oxygen and standard nasal cannula use on hypoxia and oxygenation in geriatric endoscopic retrograde cholangiopancreatography cases performed under sedation in the prone position. Data belonging to the nasal cannula group will be obtained by scanning the forms and files retrospectively. Data in the high flow nasal oxygen group will be prospectively recorded during the procedure.
After the general anesthesia approval of the patients who will be applied ERCP, they are taken to the application room in the endoscopy unit. Here, standard monitoring (pulse oximetry, electrocardiography (ECG), non-invasive blood pressure measurement) is performed according to the criteria of the American Society of Anesthesiologists (ASA). in sedated patients for endoscopic retrograde cholangiopancreatography intervention, starting 5 minutes before sedation at 5-minute intervals; During the application, blood pressure, pulse, SpO2, presence of arrhythmia, interruptions due to airway interventions are monitored by the anesthesiologist and recorded in the case report form.
After the standard monitoring is established, preoxygenation is performed for 3 minutes. Then, 5 L/min of oxygen is given through the nasal cannula throughout the procedure. Patients who will receive oxygen support with high flow nasal oxygen (Inspired O2 FLO High Flow Oxygen Therapy) will be given 40 L/min oxygen with a high flow nasal oxygen system after preoxygenation. Patients will be followed for at least 15 minutes after the procedure or until the patient recovers.
286 studies on the registry are indexed under Cholelithiasis; 48 are open to participants now.
This study's planned enrollment of 120 is below the median of 200 across 83 observational studies indexed under Cholelithiasis.
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GRUP N:(nasal grup: n=60) retrospektif =Patient data will be recorded from the retrospective patient file and archive.
GRUP H:( high flow grup: n=60)= The patient group with prospective HFNO will be included in the study and their data will be recorded.
Exclusion Criteria:
Coagulation disorder, nasopharyngeal obstruction,
The data of a total of 60 patients in the group will be recorded. Those with saturation below 92% will be included in the study. The data of the nasal cannula group will be obtained from retrospective file and archive scanning. After providing standard monitoring, preoxygenation was performed for 3 minutes. After preoxygenation, 2-4 L/min oxygen was given to the patients who would receive oxygen support by nasal cannula. Patients were followed for at least 15 minutes after the procedure or until the patient recovered. Our aim is the early recovery of patients without complications.
The data of a total of 60 patients in the group will be recorded. Those with saturation below 92% will be included in the study. After the standard monitoring is established, preoxygenation will be performed for 3 minutes. . After preoxygenation, 40 L/min oxygen will be administered through a HFNO system to patients who will receive oxygen support with HFNO ( Inspired O2 FLO High Flow Oxygen Therapy ). Patients will be followed for a minimum of 15 minutes after the procedure or until the patient recovers.
Device: HİGH-FLOW NASAL OXYGEN USE (HFNO)
It is aimed to show that the use of HFNO can improve oxygenation compared to the use of nasal cannula in ERCP procedures performed under sedation in the prone position.
Endotracheal intubation rate or complication
proportion of endotracheal intubation or complication
Time frame: 6 month
Length of hospital stay
Time in hospital in days
Time frame: 6 MONTH
Patient confort score
Visual scale varying from 0 (no disconfort) to 4 (maximal disconfort)
Time frame: 6 month
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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