clınıcal Effects of High-flow Nasal Oxygen Use ın gerıatrıc patıents

• Conditions: Biliary Stones; Oddi's Sphincter Constriction; Biliary Obstruction
• Interventions: Device: HİGH-FLOW NASAL OXYGEN USE (HFNO)

• Registration Number: NCT05432661
• Lead Sponsor: Yunus Emre

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-13
• Study Start: 2022-06-14
• Study First Submitted QC: 2022-06-23
• Last Update Submitted: 2022-06-23
• Study First Posted: 2022-06-27
• Last Update Posted: 2022-06-27
• Primary Completion: 2022-07-15
• Study Completion: 2022-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with physical condition class II-III of the American Society of Anesthesiologists, ----aged 65-90,
• with Spo2 of 92% and/or below in room air,

Exclusion Criteria

Coagulation disorder, nasopharyngeal obstruction,

• bleeding tendency,
• mental status disorder,
• dementia,
• cognitive impairment,
• intubation,
• tracheostomy,
• need for oxygen therapy due to pre-existing disease,
• patients on home oxygen or ventilator,
• pregnancy,
• recent history of epistaxis or allergy to propofol patients will be excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2 HİGH-FLOW NASAL OXYGEN	HİGH-FLOW NASAL OXYGEN USE (HFNO)	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.

Primary Outcome Measures

Name	Time	Method
Endotracheal intubation rate or complication	6 month	proportion of endotracheal intubation or complication

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	6 MONTH	Time in hospital in days