Gastro Intestinal BleedingNCT06345456
The Value of End-tidal Capnography in Gastrointestinal Bleeding
A study testing End-tidal capnography in people with Gastro Intestinal Bleeding, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Gastrointestinal bleeding is a condition that frequently presents to emergency departments and can be fatal if diagnosis and treatment are delayed. The working mechanism of end tidal capnography is simply to detect the respiratory carbon dioxide level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro Intestinal Bleeding
- What is being tested?
- End-tidal capnography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Jan 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patients presenting to the emergency department with symptoms and signs of gastrointestinal bleeding (hematochezia, melena, hematemesis).
- Patients with a presumptive diagnosis of gastrointestinal bleeding confirmed by endoscopy and colonoscopy.
- Patients who consent to participate in the study.
- Patients aged 18 and older.
Who cannot join
- Patients without symptoms and signs of gastrointestinal bleeding.
- Patients with a presumptive diagnosis of gastrointestinal bleeding ruled out by endoscopy and colonoscopy.
- Patients with respiratory pathologies that increase CO2 levels (such as asthma, COPD, pneumonia, etc.).
- Patients referred from external centers and underwent ERT replacement.
- Patients with heart failure.
- Patients who refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of End-Tidal CO2 Levels in Patients Presenting to the Emergency Department With Gastrointestinal Bleeding
Gastrointestinal bleeding is a condition that frequently presents to emergency departments and can be fatal if diagnosis and treatment are delayed. The working mechanism of end tidal capnography is simply to detect the respiratory carbon dioxide level.
In our study, the investigators aimed to determine the severity of gastrointestinal bleeding by using the Glaskow Blachford Score and AIMS65 score in cases presenting with gastrointestinal bleeding, to determine the end tidal carbon dioxide value by capnography in these cases and to determine its effectiveness in evaluating mortality and morbidity in gastrointestinal bleeding.
Read the detailed description
Gastrointestinal (GI) bleeding is a condition that frequently presents to emergency departments and has a mortal course in case of delayed diagnosis and treatment. Upper GI bleeding accounts for 5% of emergency department admissions. Mortality rates vary between 2% and 15%. Mostly, GI bleeding stops spontaneously and does not require endoscopic intervention, blood transfusion or surgery. However, among patients with life-threatening bleeding, timely intervention is very important. For this purpose, there are widely used and validated risk stratification tools such as the Glasgow Blatchford Score (GBS) and the AIMS65 score.
Capnography involves the noninvasive measurement of CO2 partial pressure during the respiratory cycle. It provides information on ventilation (efficiency of carbon dioxide elimination), perfusion (vascular CO2 transport) and metabolism (CO2 production through cellular metabolism). The principle of end-tidal capnography (ETCO2) is to detect the level of carbon dioxide in the expiratory breath.ETCO2 waveform changes provide information to physicians in various situations such as assessment of disease severity, cardiac arrest (quality of compression, return of spontaneous circulation, endotracheal tube placement, prognosis) procedural sedation and prediction of critical illness.
In our study, the investigators aimed to determine the relationship of ETCO2 value with GBS and AIMS65 scores and its effectiveness on the evaluation of morbidity and mortality in patients admitted to the emergency department with GI bleeding.
- Conditions
- Gastro Intestinal Bleeding
- Being tested
- End-tidal capnography
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End-tidal capnographyDevice
The value of end-tidal capnography
| Study group | Role | What they receive |
|---|---|---|
| Capnography device | Experimental | Not described Receives: Device: End-tidal capnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between ETCO2 value and mortality in patients with gastrointestinal bleeding will be investigated.
The correlation between ETCO2 value and mortality in patients with gastrointestinal bleeding will be investigated.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start1 Jun 2020
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Gastro Intestinal BleedingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Kilinc, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345456
- Sponsor's protocol ID
- izmirkatip
- Status last verified
- Apr 2024
- First submitted
- 22 Feb 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hearnshaw SA, Logan RF, Lowe D, Travis SP, Murphy MF, Palmer KR. Acute upper gastrointestinal bleeding in the UK: patient characteristics, diagnoses and outcomes in the 2007 UK audit. Gut. 2011 Oct;60(10):1327-35. doi: 10.1136/gut.2010.228437. Epub 2011 Apr 13.
PubMed 21490373van Leerdam ME, Vreeburg EM, Rauws EA, Geraedts AA, Tijssen JG, Reitsma JB, Tytgat GN. Acute upper GI bleeding: did anything change? Time trend analysis of incidence and outcome of acute upper GI bleeding between 1993/1994 and 2000. Am J Gastroenterol. 2003 Jul;98(7):1494-9. doi: 10.1111/j.1572-0241.2003.07517.x.
PubMed 12873568Sugawa C, Steffes CP, Nakamura R, Sferra JJ, Sferra CS, Sugimura Y, Fromm D. Upper GI bleeding in an urban hospital. Etiology, recurrence, and prognosis. Ann Surg. 1990 Oct;212(4):521-6; discussion 526-7. doi: 10.1097/00000658-199010000-00014.
PubMed 2222017Chen IC, Hung MS, Chiu TF, Chen JC, Hsiao CT. Risk scoring systems to predict need for clinical intervention for patients with nonvariceal upper gastrointestinal tract bleeding. Am J Emerg Med. 2007 Sep;25(7):774-9. doi: 10.1016/j.ajem.2006.12.024.
PubMed 17870480Pang SH, Ching JY, Lau JY, Sung JJ, Graham DY, Chan FK. Comparing the Blatchford and pre-endoscopic Rockall score in predicting the need for endoscopic therapy in patients with upper GI hemorrhage. Gastrointest Endosc. 2010 Jun;71(7):1134-40. doi: 10.1016/j.gie.2010.01.028.
PubMed 20598244Dicu D, Pop F, Ionescu D, Dicu T. Comparison of risk scoring systems in predicting clinical outcome at upper gastrointestinal bleeding patients in an emergency unit. Am J Emerg Med. 2013 Jan;31(1):94-9. doi: 10.1016/j.ajem.2012.06.009. Epub 2012 Sep 20.
PubMed 23000328Yang HM, Jeon SW, Jung JT, Lee DW, Ha CY, Park KS, Lee SH, Yang CH, Park JH, Park YS; Daegu-Gyeongbuk Gastrointestinal Study Group (DGSG). Comparison of scoring systems for nonvariceal upper gastrointestinal bleeding: a multicenter prospective cohort study. J Gastroenterol Hepatol. 2016 Jan;31(1):119-25. doi: 10.1111/jgh.13057.
PubMed 26211939Saltzman JR, Tabak YP, Hyett BH, Sun X, Travis AC, Johannes RS. A simple risk score accurately predicts in-hospital mortality, length of stay, and cost in acute upper GI bleeding. Gastrointest Endosc. 2011 Dec;74(6):1215-24. doi: 10.1016/j.gie.2011.06.024. Epub 2011 Sep 10.
PubMed 21907980Hyett BH, Abougergi MS, Charpentier JP, Kumar NL, Brozovic S, Claggett BL, Travis AC, Saltzman JR. The AIMS65 score compared with the Glasgow-Blatchford score in predicting outcomes in upper GI bleeding. Gastrointest Endosc. 2013 Apr;77(4):551-7. doi: 10.1016/j.gie.2012.11.022. Epub 2013 Jan 26.
PubMed 23357496Tang Y, Shen J, Zhang F, Zhou X, Tang Z, You T. Scoring systems used to predict mortality in patients with acute upper gastrointestinal bleeding in the ED. Am J Emerg Med. 2018 Jan;36(1):27-32. doi: 10.1016/j.ajem.2017.06.053. Epub 2017 Jun 27.
PubMed 28673695Whitaker DK. Time for capnography - everywhere. Anaesthesia. 2011 Jul;66(7):544-9. doi: 10.1111/j.1365-2044.2011.06793.x. Epub 2011 May 31. No abstract available.
PubMed 21627625Kodali BS. Capnography outside the operating rooms. Anesthesiology. 2013 Jan;118(1):192-201. doi: 10.1097/ALN.0b013e318278c8b6. No abstract available.
PubMed 23221867Nassar BS, Schmidt GA. Capnography During Critical Illness. Chest. 2016 Feb;149(2):576-585. doi: 10.1378/chest.15-1369. Epub 2016 Jan 12.
PubMed 26447854
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of End-Tidal CO2 Levels in Patients Presenting to the Emergency Department With Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT06345456
- Acronym / sponsor ID
- izmirkatip
- Conditions
- Gastro Intestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 3 Apr 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.
Gastrointestinal bleeding is a condition that frequently presents to emergency departments and can be fatal if diagnosis and treatment are delayed. The working mechanism of end tidal capnography is simply to detect the respiratory carbon dioxide level.
In our study, the investigators aimed to determine the severity of gastrointestinal bleeding by using the Glaskow Blachford Score and AIMS65 score in cases presenting with gastrointestinal bleeding, to determine the end tidal carbon dioxide value by capnography in these cases and to determine its effectiveness in evaluating mortality and morbidity in gastrointestinal bleeding.
Detailed description
Gastrointestinal (GI) bleeding is a condition that frequently presents to emergency departments and has a mortal course in case of delayed diagnosis and treatment. Upper GI bleeding accounts for 5% of emergency department admissions. Mortality rates vary between 2% and 15%. Mostly, GI bleeding stops spontaneously and does not require endoscopic intervention, blood transfusion or surgery. However, among patients with life-threatening bleeding, timely intervention is very important. For this purpose, there are widely used and validated risk stratification tools such as the Glasgow Blatchford Score (GBS) and the AIMS65 score.
Capnography involves the noninvasive measurement of CO2 partial pressure during the respiratory cycle. It provides information on ventilation (efficiency of carbon dioxide elimination), perfusion (vascular CO2 transport) and metabolism (CO2 production through cellular metabolism). The principle of end-tidal capnography (ETCO2) is to detect the level of carbon dioxide in the expiratory breath.ETCO2 waveform changes provide information to physicians in various situations such as assessment of disease severity, cardiac arrest (quality of compression, return of spontaneous circulation, endotracheal tube placement, prognosis) procedural sedation and prediction of critical illness.
In our study, the investigators aimed to determine the relationship of ETCO2 value with GBS and AIMS65 scores and its effectiveness on the evaluation of morbidity and mortality in patients admitted to the emergency department with GI bleeding.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Capnography device | Experimental | Device: End-tidal capnography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients presenting to the emergency department with symptoms and signs of gastrointestinal bleeding (hematochezia, melena, hematemesis).
- Patients with a presumptive diagnosis of gastrointestinal bleeding confirmed by endoscopy and colonoscopy.
- Patients who consent to participate in the study.
- Patients aged 18 and older.
Key exclusion criteria (6 listed)
- Patients without symptoms and signs of gastrointestinal bleeding.
- Patients with a presumptive diagnosis of gastrointestinal bleeding ruled out by endoscopy and colonoscopy.
- Patients with respiratory pathologies that increase CO2 levels (such as asthma, COPD, pneumonia, etc.).
- Patients referred from external centers and underwent ERT replacement.
- Patients with heart failure.
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 |
|---|---|---|
| End-tidal capnographyThe value of end-tidal capnography | Device | Capnography device |
Primary outcome
The correlation between ETCO2 value and mortality in patients with gastrointestinal bleeding will be investigated.
Time frame: six months
The correlation between ETCO2 value and mortality in patients with gastrointestinal bleeding will be investigated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Background: PubMed 21490373Hearnshaw SA, Logan RF, Lowe D, Travis SP, Murphy MF, Palmer KR. Acute upper gastrointestinal bleeding in the UK: patient characteristics, diagnoses and outcomes in the 2007 UK audit. Gut. 2011 Oct;60(10):1327-35. doi: 10.1136/gut.2010.228437. Epub 2011 Apr 13.
- Background: PubMed 12873568van Leerdam ME, Vreeburg EM, Rauws EA, Geraedts AA, Tijssen JG, Reitsma JB, Tytgat GN. Acute upper GI bleeding: did anything change? Time trend analysis of incidence and outcome of acute upper GI bleeding between 1993/1994 and 2000. Am J Gastroenterol. 2003 Jul;98(7):1494-9. doi: 10.1111/j.1572-0241.2003.07517.x.
- Background: PubMed 2222017Sugawa C, Steffes CP, Nakamura R, Sferra JJ, Sferra CS, Sugimura Y, Fromm D. Upper GI bleeding in an urban hospital. Etiology, recurrence, and prognosis. Ann Surg. 1990 Oct;212(4):521-6; discussion 526-7. doi: 10.1097/00000658-199010000-00014.
- Background: PubMed 17870480Chen IC, Hung MS, Chiu TF, Chen JC, Hsiao CT. Risk scoring systems to predict need for clinical intervention for patients with nonvariceal upper gastrointestinal tract bleeding. Am J Emerg Med. 2007 Sep;25(7):774-9. doi: 10.1016/j.ajem.2006.12.024.
- Background: PubMed 20598244Pang SH, Ching JY, Lau JY, Sung JJ, Graham DY, Chan FK. Comparing the Blatchford and pre-endoscopic Rockall score in predicting the need for endoscopic therapy in patients with upper GI hemorrhage. Gastrointest Endosc. 2010 Jun;71(7):1134-40. doi: 10.1016/j.gie.2010.01.028.
- Background: PubMed 23000328Dicu D, Pop F, Ionescu D, Dicu T. Comparison of risk scoring systems in predicting clinical outcome at upper gastrointestinal bleeding patients in an emergency unit. Am J Emerg Med. 2013 Jan;31(1):94-9. doi: 10.1016/j.ajem.2012.06.009. Epub 2012 Sep 20.
- Background: PubMed 26211939Yang HM, Jeon SW, Jung JT, Lee DW, Ha CY, Park KS, Lee SH, Yang CH, Park JH, Park YS; Daegu-Gyeongbuk Gastrointestinal Study Group (DGSG). Comparison of scoring systems for nonvariceal upper gastrointestinal bleeding: a multicenter prospective cohort study. J Gastroenterol Hepatol. 2016 Jan;31(1):119-25. doi: 10.1111/jgh.13057.
- Background: PubMed 21907980Saltzman JR, Tabak YP, Hyett BH, Sun X, Travis AC, Johannes RS. A simple risk score accurately predicts in-hospital mortality, length of stay, and cost in acute upper GI bleeding. Gastrointest Endosc. 2011 Dec;74(6):1215-24. doi: 10.1016/j.gie.2011.06.024. Epub 2011 Sep 10.
- Background: PubMed 23357496Hyett BH, Abougergi MS, Charpentier JP, Kumar NL, Brozovic S, Claggett BL, Travis AC, Saltzman JR. The AIMS65 score compared with the Glasgow-Blatchford score in predicting outcomes in upper GI bleeding. Gastrointest Endosc. 2013 Apr;77(4):551-7. doi: 10.1016/j.gie.2012.11.022. Epub 2013 Jan 26.
- Background: PubMed 28673695Tang Y, Shen J, Zhang F, Zhou X, Tang Z, You T. Scoring systems used to predict mortality in patients with acute upper gastrointestinal bleeding in the ED. Am J Emerg Med. 2018 Jan;36(1):27-32. doi: 10.1016/j.ajem.2017.06.053. Epub 2017 Jun 27.
- Background: PubMed 21627625Whitaker DK. Time for capnography - everywhere. Anaesthesia. 2011 Jul;66(7):544-9. doi: 10.1111/j.1365-2044.2011.06793.x. Epub 2011 May 31. No abstract available.
- Background: PubMed 23221867Kodali BS. Capnography outside the operating rooms. Anesthesiology. 2013 Jan;118(1):192-201. doi: 10.1097/ALN.0b013e318278c8b6. No abstract available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End-tidal capnography in people with Gastro Intestinal Bleeding, run by Izmir Katip Celebi University 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 8 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The correlation between ETCO2 value and mortality in patients with gastrointestinal bleeding will be investigated. (time frame: six months). 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 NCT06345456, which also lists 13 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 8 Apr 2024.