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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05432661
Acronym
HFNO
Enrollment
120
Registered
2022-06-27
Start date
2022-06-14
Completion date
2022-07-25
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary Obstruction, Biliary Stones, Oddi's Sphincter Constriction

Keywords

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

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.

Interventions

DEVICEHİGH-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.

Sponsors

Yunus Emre
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Endotracheal intubation rate or complication6 monthproportion of endotracheal intubation or complication

Secondary

MeasureTime frameDescription
Length of hospital stay6 MONTHTime in hospital in days

Other

MeasureTime frameDescription
Patient confort score6 monthVisual scale varying from 0 (no disconfort) to 4 (maximal disconfort)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026