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

Sponsor
Yunus Emre (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05432661
Collaborator
(none)
120
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HİGH-FLOW NASAL OXYGEN USE (HFNO)

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
120 participants
Observational Model:
Case-Only
Time Perspective:
Other
Official Title:
clınıcal Effects of High-flow Nasal Oxygen Use ın gerıatrıc patıents usıng Endoscopic Retrograde Cholangiopancreatography Under sedatıon
Anticipated Study Start Date :
Jun 14, 2022
Anticipated Primary Completion Date :
Jul 15, 2022
Anticipated Study Completion Date :
Jul 25, 2022

Arms and Interventions

Arm Intervention/Treatment
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)
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.

Outcome Measures

Primary Outcome Measures

  1. Endotracheal intubation rate or complication [6 month]

    proportion of endotracheal intubation or complication

Secondary Outcome Measures

  1. Length of hospital stay [6 MONTH]

    Time in hospital in days

Other Outcome Measures

  1. Patient confort score [6 month]

    Visual scale varying from 0 (no disconfort) to 4 (maximal disconfort)

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Yunus Emre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yunus Emre, SPECIALIST DOCTOR, Ankara Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05432661
Other Study ID Numbers:
  • ytuncdemir
First Posted:
Jun 27, 2022
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yunus Emre, SPECIALIST DOCTOR, Ankara Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022