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

Biliary Obstruction Clinical Trial

— HFNO  

Official title:

clınıcal Effects of High-flow Nasal Oxygen Use ın gerıatrıc patıents usıng Endoscopic Retrograde Cholangiopancreatography Under sedatıon

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05432661
• Other study ID #: ytuncdemir
• Status: Not yet recruiting
• Start date: June 14, 2022
• Est. completion date: July 25, 2022

Study information

• Verified date: June 2022
• Source: Ankara Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 25, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Obstruction
• Biliary Stones
• Cholecystolithiasis
• Cholelithiasis
• Constriction, Pathologic
• Gallstones

Intervention

Device:
• HIGH-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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yunus Emre

References & Publications (3)

Cha B, Lee MJ, Park JS, Jeong S, Lee DH, Park TG. Clinical efficacy of high-flow nasal oxygen in patients undergoing ERCP under sedation. Sci Rep. 2021 Jan 11;11(1):350. doi: 10.1038/s41598-020-79798-7. — View Citation

Schumann R, Natov NS, Rocuts-Martinez KA, Finkelman MD, Phan TV, Hegde SR, Knapp RM. High-flow nasal oxygen availability for sedation decreases the use of general anesthesia during endoscopic retrograde cholangiopancreatography and endoscopic ultrasound. — View Citation

Thiruvenkatarajan V, Dharmalingam A, Arenas G, Wahba M, Steiner R, Kadam VR, Tran A, Currie J, Van Wijk R, Quail A, Ludbrook G. High-flow nasal cannula versus standard oxygen therapy assisting sedation during endoscopic retrograde cholangiopancreatography — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient confort score	Visual scale varying from 0 (no disconfort) to 4 (maximal disconfort)	6 month
Primary	Endotracheal intubation rate or complication	proportion of endotracheal intubation or complication	6 month
Secondary	Length of hospital stay	Time in hospital in days	6 MONTH