NCT06345456

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 22, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 3, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

7 months

First QC Date

February 22, 2024

Last Update Submit

April 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    six months

Study Arms (1)

Capnography device

EXPERIMENTAL
Device: End-tidal capnography

Interventions

The value of end-tidal capnography

Capnography device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Katip Çelebi Üniversitesi

Izmir, Turkey (Türkiye)

Location

Related Publications (13)

  • 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.

    PMID: 21490373BACKGROUND
  • van 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.

    PMID: 12873568BACKGROUND
  • Sugawa 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.

    PMID: 2222017BACKGROUND
  • Chen 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.

    PMID: 17870480BACKGROUND
  • Pang 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.

    PMID: 20598244BACKGROUND
  • Dicu 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.

    PMID: 23000328BACKGROUND
  • Yang 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.

    PMID: 26211939BACKGROUND
  • Saltzman 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.

    PMID: 21907980BACKGROUND
  • Hyett 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.

    PMID: 23357496BACKGROUND
  • Tang 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.

    PMID: 28673695BACKGROUND
  • Whitaker 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.

    PMID: 21627625BACKGROUND
  • Kodali BS. Capnography outside the operating rooms. Anesthesiology. 2013 Jan;118(1):192-201. doi: 10.1097/ALN.0b013e318278c8b6. No abstract available.

    PMID: 23221867BACKGROUND
  • Nassar BS, Schmidt GA. Capnography During Critical Illness. Chest. 2016 Feb;149(2):576-585. doi: 10.1378/chest.15-1369. Epub 2016 Jan 12.

    PMID: 26447854BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medicine doctor

Study Record Dates

First Submitted

February 22, 2024

First Posted

April 3, 2024

Study Start

June 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

April 8, 2024

Record last verified: 2024-04

Locations