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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05432661
Other study ID # ytuncdemir
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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