Atmospheric Pressure; Adverse EffectNCT06531577
Atmospheric Pressure and Epistaxis Relationship
An observational study of Atmospheric Pressure; Adverse Effect and Epistaxis Nosebleed, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
In this study, investigators aim to understand the relationship between changes in atmospheric pressure and blood pressure, and to investigate whether these changes have an impact on the etiology of epistaxis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atmospheric Pressure; Adverse Effect, Epistaxis Nosebleed
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Apr 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients over the age of 18 presenting to emergency department with epistaxis
Who may be able to join
- Patients aged 18 and above Presenting to the emergency department with complaints of epistaxis, whether active or resolved.
- Willing volunteers consenting to participate in the study. Residing in central districts of Ankara
Who cannot join
- Patients under the age of 18. Pregnant individuals. Those with a history of maxillofacial surgery. Patients reporting a history of trauma at the time of admission. Patients stating they are from a city other than Ankara.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara, Yenimahalle, 06170
gulsen akcay, ass. prof., +905052874949, gulakcay@yahoo.com.tr
mehmet ceylan, resident, +905073046839, mhmtcyln71mtf@gmail.com
About this study
Official title: Influence of Atmospheric Pressure on Patients Presenting to the Emergency Department With Epistaxis
In this study, investigators aim to understand the relationship between changes in atmospheric pressure and blood pressure, and to investigate whether these changes have an impact on the etiology of epistaxis.
Read the detailed description
This study aims to investigate the potential effects of changes in atmospheric pressure on epistaxis and, if such effects exist, to review treatment adjustments based on weather forecasts for hypertensive patients to prevent potential hypertensive emergencies and enhance patient comfort. This research poses no risk to patients and is purely observational and clinical in nature.
The study will be conducted prospectively over a period of 6 months at the Emergency Department of Ankara Etlik City Hospital, focusing on patients presenting with epistaxis.After initial evaluation upon presentation to the emergency department, patients will undergo routine emergency department monitoring for epistaxis, including physical examination, vital sign monitoring, evaluation of coagulation parameters, and hemoglobin levels. Apart from routine tests, no additional invasive or non-invasive procedures will be performed by us.
Data obtained from patients and daily atmospheric pressure parameters will be evaluated and analyzed.
- Keywords
- atmospheric pressure, epistaxis, blood pressure
- Medical subject headings
- Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| epistaxis group | patients presenting to emergency department with epistaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
epistaxis
number of the patients with epistaxis will be evaluated accoridng to atmospheric preesure and wheather conditions on daily basis
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Apr 2024
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atmospheric Pressure; Adverse EffectStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Responsible party
- Sponsor
- Investigators
- gulsen akcay, ass. prof., Study director, ass. prof. of organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531577
- Sponsor's protocol ID
- atmospheric pressure
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jelavic B, Majstorovic Z, Kordic M, Leventic M, Grgic MV, Baudoin T. Idiopathic epistaxis and meteorological factors: case-control study. B-ENT. 2015;11(4):267-73.
PubMed 26891538Min SJ, Kang H, Kim KS, Min HJ. Minimal temperature, mean wind speed, and mean relative humidity are associated with spontaneous epistaxis in Seoul, Korea. Auris Nasus Larynx. 2021 Feb;48(1):98-103. doi: 10.1016/j.anl.2020.07.012. Epub 2020 Jul 25.
PubMed 32718810
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Atmospheric Pressure on Patients Presenting to the Emergency Department With Epistaxis
- ClinicalTrials.gov ID
- NCT06531577
- Acronym / sponsor ID
- atmospheric pressure
- Keywords
- atmospheric pressure, epistaxis, blood pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 1 Aug 2024 (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.
In this study, investigators aim to understand the relationship between changes in atmospheric pressure and blood pressure, and to investigate whether these changes have an impact on the etiology of epistaxis.
Detailed description
This study aims to investigate the potential effects of changes in atmospheric pressure on epistaxis and, if such effects exist, to review treatment adjustments based on weather forecasts for hypertensive patients to prevent potential hypertensive emergencies and enhance patient comfort. This research poses no risk to patients and is purely observational and clinical in nature.
The study will be conducted prospectively over a period of 6 months at the Emergency Department of Ankara Etlik City Hospital, focusing on patients presenting with epistaxis.After initial evaluation upon presentation to the emergency department, patients will undergo routine emergency department monitoring for epistaxis, including physical examination, vital sign monitoring, evaluation of coagulation parameters, and hemoglobin levels. Apart from routine tests, no additional invasive or non-invasive procedures will be performed by us.
Data obtained from patients and daily atmospheric pressure parameters will be evaluated and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epistaxis group | – | –patients presenting to emergency department with epistaxis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients over the age of 18 presenting to emergency department with epistaxis
Key inclusion criteria (2 listed)
- Patients aged 18 and above Presenting to the emergency department with complaints of epistaxis, whether active or resolved.
- Willing volunteers consenting to participate in the study. Residing in central districts of Ankara
Key exclusion criteria (1 listed)
- Patients under the age of 18. Pregnant individuals. Those with a history of maxillofacial surgery. Patients reporting a history of trauma at the time of admission. Patients stating they are from a city other than Ankara.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
epistaxis
Time frame: 24 hours
number of the patients with epistaxis will be evaluated accoridng to atmospheric preesure and wheather conditions on daily basis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 26891538Jelavic B, Majstorovic Z, Kordic M, Leventic M, Grgic MV, Baudoin T. Idiopathic epistaxis and meteorological factors: case-control study. B-ENT. 2015;11(4):267-73.
- Background: PubMed 32718810Min SJ, Kang H, Kim KS, Min HJ. Minimal temperature, mean wind speed, and mean relative humidity are associated with spontaneous epistaxis in Seoul, Korea. Auris Nasus Larynx. 2021 Feb;48(1):98-103. doi: 10.1016/j.anl.2020.07.012. Epub 2020 Jul 25.
- Individual participant dataSharing planned: No
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.
gulsen akcay, ass. prof. study director
ass. prof. of organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atmospheric Pressure; Adverse Effect and Epistaxis Nosebleed, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 1 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 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact gulsen akcay, ass. prof. (+905052874949, gulakcay@yahoo.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epistaxis (time frame: 24 hours). 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 NCT06531577, which also lists 2 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 1 Aug 2024.