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

NCT05432661 | Unknown

• 1 other identifier: ytuncdemir
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Biliary Obstruction; Oddi's Sphincter Constriction; Biliary Stones

Keywords

nasal oxygen; high flow nasal oxygen; geriatric; endoskopic retrograde cholangiopancreatography

Outcome Measures

Primary Outcomes (1)

• Endotracheal intubation rate or complication

  proportion of endotracheal intubation or complication

  6 month

Secondary Outcomes (1)

• Length of hospital stay

  6 MONTH

Other Outcomes (1)

• Patient confort score

  6 month

Study Arms (2)

1 nasal kanul

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.

2 HİGH-FLOW NASAL OXYGEN

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)

Interventions

HİGH-FLOW NASAL OXYGEN USE (HFNO) DEVICE

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.

2 HİGH-FLOW NASAL OXYGEN

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yunus Emre: lead

Related Publications (3)

• 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.

  PMID: 32471494 RESULT

• 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.

  PMID: 28058020 RESULT

• 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.

  PMID: 33432035 RESULT

MeSH Terms

Conditions

Cholecystolithiasis

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: SPECIALIST DOCTOR

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 27, 2022
• Study Start: June 14, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 25, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06