Biliary ObstructionHFNONCT05432661
clınıcal Effects of High-flow Nasal Oxygen Use ın gerıatrıc patıents
An observational study of Biliary Obstruction and Oddi's Sphincter Constriction, run by Yunus Emre.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Biliary Obstruction, Oddi's Sphincter Constriction, Biliary Stones
- What is being tested?
- HİGH-FLOW NASAL OXYGEN USE (HFNO)
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 14 Jun 2022to 25 Jul 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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,
Who cannot join
- Coagulation disorder, nasopharyngeal obstruction,
- bleeding tendency,
- mental status disorder,
- dementia,
- cognitive impairment,
- intubation,
Show all 11Show fewer
- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- HİGH-FLOW NASAL OXYGEN USE (HFNO)
- Keywords
- nasal oxygen, high flow nasal oxygen, geriatric, endoskopic retrograde cholangiopancreatography
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HİGH-FLOW NASAL OXYGEN USE (HFNO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotracheal intubation rate or complication
proportion of endotracheal intubation or complication
Measured: 6 month
Secondary outcomes (1)
Length of hospital stay
Time in hospital in days
Measured: 6 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start14 Jun 2022 (estimated)
- Primary completion15 Jul 2022 (estimated)
- Study completion25 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Biliary ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Yunus Emre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yunus Emre, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432661
- Sponsor's protocol ID
- ytuncdemir
- Acronym
- HFNO
- Status last verified
- Jun 2022
- First submitted
- 13 Jun 2022
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32471494Schumann 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.
PubMed 28058020Cha 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.
PubMed 33432035
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- clınıcal Effects of High-flow Nasal Oxygen Use ın gerıatrıc patıents usıng Endoscopic Retrograde Cholangiopancreatography Under sedatıon
- ClinicalTrials.gov ID
- NCT05432661
- Acronym / sponsor ID
- HFNO / ytuncdemir
- Keywords
- nasal oxygen, high flow nasal oxygen, geriatric, endoskopic retrograde cholangiopancreatography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yunus EmreUniversity, hospital or other
- Study start
- 14 Jun 2022 (estimated)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 25 Jul 2022 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: HİGH-FLOW NASAL OXYGEN USE (HFNO)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. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- 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,
Key exclusion criteria (11 listed)
- Coagulation disorder, nasopharyngeal obstruction,
- bleeding tendency,
- mental status disorder,
- dementia,
- cognitive impairment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | 2 HİGH-FLOW NASAL OXYGEN |
Primary outcome
Endotracheal intubation rate or complication
Time frame: 6 month
proportion of endotracheal intubation or complication
1 secondary outcome
Length of hospital stay
Time frame: 6 MONTH
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Results publication: PubMed 32471494Thiruvenkatarajan 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.
- Results publication: PubMed 28058020Schumann 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.
- Results publication: PubMed 33432035Cha 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Obstruction and Oddi's Sphincter Constriction, run by Yunus Emre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endotracheal intubation rate or complication (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05432661, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.