Clinical trial NCT05432661: clınıcal Effects of High-flow Nasal Oxygen Use ın gerıatrıc patıents
Official title: clınıcal Effects of High-flow Nasal Oxygen Use ın gerıatrıc patıents usıng Endoscopic Retrograde Cholangiopancreatography Under sedatıon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Biliary Obstruction
Oddi's Sphincter Constriction
Biliary Stones
Keywords: nasal oxygen
high flow nasal oxygen
geriatric
endoskopic retrograde cholangiopancreatography
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Endotracheal intubation rate or complication
timeFrame: 6 month
Secondary outcomes:
measure: Length of hospital stay
timeFrame: 6 MONTH
Other outcomes:
measure: Patient confort score
timeFrame: 6 month
Locations:
Study officials:
References:
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 in high risk cases (OTHER): study protocol of a randomised multicentric trial. Trials. 2020 May 29;21(1):444. doi: 10.1186/s13063-020-04378-z.
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. World J Gastroenterol. 2016 Dec 21;22(47):10398-10405. doi: 10.3748/wjg.v22.i47.10398.
citation: 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.