Atmospheric Pressure; Adverse EffectNCT06515353
Gastrointestinal Bleeding and Atmospheric Pressure Relationship
An observational study of Atmospheric Pressure; Adverse Effect and GastroIntestinal Bleeding, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate whether atmospheric pressure has an effect on upper gastrointestinal bleeding (UGIB), which includes causes such as peptic ulcer disease, esophagitis, gastritis, gastrointestinal varices, Mallory-Weiss tears, and gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atmospheric Pressure; Adverse Effect, GastroIntestinal Bleeding
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2024to 5 Nov 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to emergency department with gastrointestinal bleeding
Who may be able to join
- Patients aged 18 and above Patients presenting to the emergency department with complaints of gastrointestinal bleeding, whether active or resolved Patients willing to participate in the study Patients from central districts of Ankara
Who cannot join
- Patients under the age of 18 Pregnant individuals Patients with a history of trauma at the time of admission Patients declaring 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
emre kagan unal, resident, +905443539793, emrekaganunal@hotmail.com
About this study
Official title: The Effect of Atmospheric Pressure on Patients Presenting to the Emergency Department With Gastrointestinal Bleeding
This study aims to investigate whether atmospheric pressure has an effect on upper gastrointestinal bleeding (UGIB), which includes causes such as peptic ulcer disease, esophagitis, gastritis, gastrointestinal varices, Mallory-Weiss tears, and gastric cancer. The goal is to determine the impact of atmospheric pressure and gather information on its role in high-risk UGIB.
Read the detailed description
ur study aims to investigate the potential effects of changes in atmospheric pressure on gastrointestinal bleeding, 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.
After initial evaluation upon presentation to the emergency department, patients will undergo routine emergency department monitoring for gastrointestinal bleeding, 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.
Obtained data from patients and atmospheric pressure data will be analyzed and evaluated. Results will be analyzed to determine any relation between gastrointestinal bleeding and atmospheric pressure changes
- Keywords
- atmospheric pressure, gastrointestinal bleeding, emergency department
- Medical subject headings
- Gastrointestinal Hemorrhage, Emergencies
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 |
|---|---|---|
| GI Bleeding | Patients administered to emergency department with GI bleeding will be scrrened and obtained retrospectively from hospital system. Atmospheric pressure data will be obtained from Meteorology Directorate. Patients' data will be evaluated according to atmospheric pressure values. |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastrointestinal bleeding
patients administered to emergency department with gastrointestinal bleeding
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 posted23 Jul 2024
- Study start5 Apr 2024
- Primary completion5 Nov 2024 (estimated)
- Study completion5 Nov 2024 (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 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
- Retrospective
- Enrolment
- 250 participants (estimated)
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
- NCT06515353
- Sponsor's protocol ID
- GIB and Atmospheric Pressure
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guo CG, Tian L, Zhang F, Cheung KS, Leung WK. Associations of seasonal variations and meteorological parameters with incidences of upper and lower gastrointestinal bleeding. J Gastroenterol Hepatol. 2021 Dec;36(12):3354-3362. doi: 10.1111/jgh.15632. Epub 2021 Jul 30.
PubMed 34289518Prechter F, Burger M, Lehmann T, Stallmach A, Schmidt C. A study on the correlation of gastrointestinal bleeding and meteorological factors - is there a weather condition for GI bleeding? Z Gastroenterol. 2019 Dec;57(12):1476-1480. doi: 10.1055/a-1008-9863. Epub 2019 Dec 11.
PubMed 31826278Lenzen H, Musmann E, Kottas M, Schonemeier B, Kohnlein T, Manns MP, Lankisch TO. Acute gastrointestinal bleeding cases presenting to the emergency department are associated with age, sex and seasonal and circadian factors. Eur J Gastroenterol Hepatol. 2017 Jan;29(1):78-83. doi: 10.1097/MEG.0000000000000752.
PubMed 27662496
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Atmospheric Pressure on Patients Presenting to the Emergency Department With Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT06515353
- Acronym / sponsor ID
- GIB and Atmospheric Pressure
- Keywords
- atmospheric pressure, gastrointestinal bleeding, emergency department
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 5 Nov 2024 (estimated)
- Study completion
- 5 Nov 2024 (estimated)
- First posted
- 23 Jul 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.
This study aims to investigate whether atmospheric pressure has an effect on upper gastrointestinal bleeding (UGIB), which includes causes such as peptic ulcer disease, esophagitis, gastritis, gastrointestinal varices, Mallory-Weiss tears, and gastric cancer. The goal is to determine the impact of atmospheric pressure and gather information on its role in high-risk UGIB.
Detailed description
ur study aims to investigate the potential effects of changes in atmospheric pressure on gastrointestinal bleeding, 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.
After initial evaluation upon presentation to the emergency department, patients will undergo routine emergency department monitoring for gastrointestinal bleeding, 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.
Obtained data from patients and atmospheric pressure data will be analyzed and evaluated. Results will be analyzed to determine any relation between gastrointestinal bleeding and atmospheric pressure changes
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GI Bleeding | – | –Patients administered to emergency department with GI bleeding will be scrrened and obtained retrospectively from hospital system. Atmospheric pressure data will be obtained from Meteorology Directorate. Patients' data will be evaluated according to atmospheric pressure values. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to emergency department with gastrointestinal bleeding
Key inclusion criteria (1 listed)
- Patients aged 18 and above Patients presenting to the emergency department with complaints of gastrointestinal bleeding, whether active or resolved Patients willing to participate in the study Patients from central districts of Ankara
Key exclusion criteria (1 listed)
- Patients under the age of 18 Pregnant individuals Patients with a history of trauma at the time of admission Patients declaring 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
gastrointestinal bleeding
Time frame: 24 hours
patients administered to emergency department with gastrointestinal bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Background: PubMed 34289518Guo CG, Tian L, Zhang F, Cheung KS, Leung WK. Associations of seasonal variations and meteorological parameters with incidences of upper and lower gastrointestinal bleeding. J Gastroenterol Hepatol. 2021 Dec;36(12):3354-3362. doi: 10.1111/jgh.15632. Epub 2021 Jul 30.
- Background: PubMed 31826278Prechter F, Burger M, Lehmann T, Stallmach A, Schmidt C. A study on the correlation of gastrointestinal bleeding and meteorological factors - is there a weather condition for GI bleeding? Z Gastroenterol. 2019 Dec;57(12):1476-1480. doi: 10.1055/a-1008-9863. Epub 2019 Dec 11.
- Background: PubMed 27662496Lenzen H, Musmann E, Kottas M, Schonemeier B, Kohnlein T, Manns MP, Lankisch TO. Acute gastrointestinal bleeding cases presenting to the emergency department are associated with age, sex and seasonal and circadian factors. Eur J Gastroenterol Hepatol. 2017 Jan;29(1):78-83. doi: 10.1097/MEG.0000000000000752.
- 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 GastroIntestinal Bleeding, 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 1 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 23 Jul 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?
gastrointestinal bleeding (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 NCT06515353, 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 23 Jul 2024.