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

June 23, 2022 updated by: Yunus Emre

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years to 86 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endotracheal intubation rate or complication
Time Frame: 6 month
proportion of endotracheal intubation or complication
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: 6 MONTH
Time in hospital in days
6 MONTH

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient confort score
Time Frame: 6 month
Visual scale varying from 0 (no disconfort) to 4 (maximal disconfort)
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yunus Emre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 14, 2022

Primary Completion (Anticipated)

July 15, 2022

Study Completion (Anticipated)

July 25, 2022

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 23, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Actual)

June 27, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ytuncdemir

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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