Upper Gastrointestinal BleedingNCT03944148
Thoracic Ultrasound on Upper Gastrointestinal Bleeding (ECOBLEDSTUDY)
An observational study of Upper Gastrointestinal Bleeding, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Upper Gastrointestinal bleeding (UGIB) is a medical emergency and the most common cause of hospitalization associated with digestive disease. Proper initial resuscitation is the first step in the management of UGIB patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- How many people
- 110 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jul 2019to 30 Dec 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with variceal and non-variceal UGIB, who arrive to the emergency department of the University Hospital, "Dr. José E. González" Universidad Autónoma de Nuevo León.
Who may be able to join
- Age, more than 17 years old.
- Patients diagnosed with UGIB.
- Any etiology of the UGIB.
Who cannot join
- Patients with UGIB previously treated in other hospitals.
- Patients with UGIB with Blatchford scale less than 2 points.
- Pregnant women.
- Refusal to participate in the protocol.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. Jose E. Gonzalez, Universidad Autónoma de Nuevo León
Monterrey, Nuevo León, 64460
About this study
Official title: Thoracic Point of Care Ultrasound on Initial Management of Upper Gastrointestinal Bleeding
Upper Gastrointestinal bleeding (UGIB) is a medical emergency and the most common cause of hospitalization associated with digestive disease. Proper initial resuscitation is the first step in the management of UGIB patients. Today, modern pulmonary ultrasound is used in different clinical settings, such as intensive care, emergency medicine and/or traumatology. In the last years, the use of this has been standardized both in internal medicine and in pulmonary medicine. The primary objective is to describe the findings of pulmonary ultrasound and its relationship with severity in patients with UGIB. The investigators will include all patients with UGIB. A pulmonary and vena cava ultrasound will be performed on admission to the emergency room, 10 minutes prior to endoscopy and 24 hours after having performed the endoscopy.
The use of thoracic point-of-care ultrasound (TPOCUS) has been standardized in both internal and pulmonary medicine. There is a concern about the role of TPOCUS useful as a severity prognostic tool in patients with UGIB.
Read more
The team proposes that TPOCUS is a severity prognostic tool in UGIB patients.
Main Outcome: To describe the findings of TPOCUS in patients with variceal and non-variceal UGIB.
Secondary Objectives:
- Correlate the presence of B-type lines on TPOCUS with mean arterial pressure in UGIB patients.
- Correlate the inferior vena cava diameter with the Model for End-stage Liver Disease scale in UGIB patients.
- Correlate the inferior vena cava diameter with the 48 hours post-admission mortality of UGIB patients.
Authors design a prospective, longitudinal, descriptive study to identify the findings of TPOCUS in patients with variceal and non-variceal UGIB. Patients will be included in the study since May 15th through October 30th 2019, admitted to the University Hospital, "Dr. José E. González", Universidad Autónoma de Nuevo León.
Read the detailed description
Inclusion criteria:
- Patients with a diagnosis of UGIB documented by endoscopy.
- Any gender.
- Over 18 years old.
Exclusion criteria:
- Patients with UGIB previously treated in other hospitals.
- Patients under 18 years of age.
- Patients with suspected UGIB who did not undergo endoscopy.
- Pregnant.
- Patients with chronic obstructive pulmonary disease.
- Patients with interstitial lung disease.
- Patients with pleural effusion at the time of admission to the emergency room.
- Refusal to participate in the protocol.
Method The investigators will study all patients who come to the emergency room of the hospital due to suspicion of UGIB (melena, hematemesis, vomiting in coffee grounds and hematochezia with hemodynamic instability). These patients will undergo a pulmonary and vena cava ultrasound.
Patients with suspected UGIB who are candidates for upper endoscopy during their hospital stay will undergo a second pulmonary and vena cava ultrasound ten minutes prior to upper endoscopy.
The investigators will include in the research study patients with UGIB documented by upper endoscopy. The investigators will perform a third pulmonary and vena cava ultrasound 24 hours after the endoscopic procedure.
The investigators will exclude patients with suspected UGIB but who are not candidates for endoscopy.
The technique used is a bilateral intercostal thoracic point-of-care ultrasound (TPOCUS) with the patient in supine decubitus with the head at 30 degrees. Each hemithorax will be divided into 4 areas: anterior and lateral, superior and inferior. The anterior area will be delineated between the clavicle and the diaphragm and between the parasternal line to the anterior axillary line. The lateral area will be delineated between the axilla and the diaphragm and between the anterior to the posterior axillary line. The superior area will be delineated from the 1st to the 3rd intercostal space and the lower area from the 4th to the 6th intercostal space. A total of 8 areas of the chest will be visualized during normal breathing.
The TPOCUS findings to report are:
B-type lines: Those lines are hydro-aerial artifacts presenting as comet tail images, begin in the pleural line, are hyper-echoic, well defined, disseminated towards the end of the screen, delete A-type lines, and move with the pleural slip when this it is present. The lines separated from each other around 7 mm correspond to interstitial edema, while those that distance 3 mm indicate the presence of alveolar edema. The presence of more than 3 B-type lines indicates the presence of an alveolar-interstitial syndrome.
The inferior cava vein evaluation will be performed by measuring the diameter and percentage of collapse of this vein. It will be performed in the subxiphoid window with the identification of the four cardiac chambers, then a 90º turn of the transducer will made in the cephalad direction, which will show the right atrium, the union of the inferior vena cava and the liver above it. The diameter measurement will be beyond the point of confluence of the hepatic veins, usually found approximately 2 cm from the union of the inferior vena cava and the right atrium. Based on the diameter and collapse percentage measurement of the inferior vena cava on spontaneous breathing, a volume status will be defined as lack of volume if the diameter is <2 cm and the collapse percentage is >50%; however, a diameter >2 cm and a collapse percentage <50% will be classified as hypervolemic state.
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Upper Gastrointestinal Bleeding
- Medical subject headings
- Gastrointestinal Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
B-type lines on thoracic point-of-care ultrasound in patients with UGIB.
The number of B-type lines measured by thoracic point-of-care ultrasound in patients with variceal and non-variceal UGIB at 48 hours.
Measured: 48 hours
Diameter of inferior vena cava on thoracic point-of-care ultrasound in patients with UGIB.
The diameter in centimeters of inferior vena cava measured by thoracic point-of-care ultrasound in patients with variceal and non-variceal UGIB at 48 hours.
Measured: 48 hours
Secondary outcomes (3)
B-type lines and mean arterial pressure on UGIB patients
To correlate the presence of B-type lines on thoracic point-of-care ultrasound with mean arterial pressure in UGIB patients.
Measured: 48 hours
Inferior vena cava diameter and Model for End-stage Liver Disease on UGIB patients
To correlate the inferior vena cava diameter with the Model for End-stage Liver Disease scale in UGIB patients.
Measured: 48 hours
Inferior vena cava diameter and 48 hours mortality in UGIB patients.
To correlate the inferior vena cava diameter with the 48 hours post-admission mortality rate in UGIB patients.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 Jul 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Hector Eloy Tamez Perez, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- Hector Ibarra Sifuentes, M.D., Principal investigator, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944148
- Sponsor's protocol ID
- G19-00001
- Status last verified
- Dec 2019
- First submitted
- 16 Apr 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If need information will be available upon email contact request.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Point of Care Ultrasound on Initial Management of Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT03944148
- Acronym / sponsor ID
- G19-00001
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Upper Gastrointestinal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 9 May 2019 (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.
Upper Gastrointestinal bleeding (UGIB) is a medical emergency and the most common cause of hospitalization associated with digestive disease. Proper initial resuscitation is the first step in the management of UGIB patients. Today, modern pulmonary ultrasound is used in different clinical settings, such as intensive care, emergency medicine and/or traumatology. In the last years, the use of this has been standardized both in internal medicine and in pulmonary medicine. The primary objective is to describe the findings of pulmonary ultrasound and its relationship with severity in patients with UGIB. The investigators will include all patients with UGIB. A pulmonary and vena cava ultrasound will be performed on admission to the emergency room, 10 minutes prior to endoscopy and 24 hours after having performed the endoscopy.
The use of thoracic point-of-care ultrasound (TPOCUS) has been standardized in both internal and pulmonary medicine. There is a concern about the role of TPOCUS useful as a severity prognostic tool in patients with UGIB.
The team proposes that TPOCUS is a severity prognostic tool in UGIB patients.
Main Outcome: To describe the findings of TPOCUS in patients with variceal and non-variceal UGIB.
Secondary Objectives:
- Correlate the presence of B-type lines on TPOCUS with mean arterial pressure in UGIB patients.
- Correlate the inferior vena cava diameter with the Model for End-stage Liver Disease scale in UGIB patients.
- Correlate the inferior vena cava diameter with the 48 hours post-admission mortality of UGIB patients.
Authors design a prospective, longitudinal, descriptive study to identify the findings of TPOCUS in patients with variceal and non-variceal UGIB. Patients will be included in the study since May 15th through October 30th 2019, admitted to the University Hospital, "Dr. José E. González", Universidad Autónoma de Nuevo León.
Detailed description
Inclusion criteria:
- Patients with a diagnosis of UGIB documented by endoscopy.
- Any gender.
- Over 18 years old.
Exclusion criteria:
- Patients with UGIB previously treated in other hospitals.
- Patients under 18 years of age.
- Patients with suspected UGIB who did not undergo endoscopy.
- Pregnant.
- Patients with chronic obstructive pulmonary disease.
- Patients with interstitial lung disease.
- Patients with pleural effusion at the time of admission to the emergency room.
- Refusal to participate in the protocol.
Method The investigators will study all patients who come to the emergency room of the hospital due to suspicion of UGIB (melena, hematemesis, vomiting in coffee grounds and hematochezia with hemodynamic instability). These patients will undergo a pulmonary and vena cava ultrasound.
Patients with suspected UGIB who are candidates for upper endoscopy during their hospital stay will undergo a second pulmonary and vena cava ultrasound ten minutes prior to upper endoscopy.
The investigators will include in the research study patients with UGIB documented by upper endoscopy. The investigators will perform a third pulmonary and vena cava ultrasound 24 hours after the endoscopic procedure.
The investigators will exclude patients with suspected UGIB but who are not candidates for endoscopy.
The technique used is a bilateral intercostal thoracic point-of-care ultrasound (TPOCUS) with the patient in supine decubitus with the head at 30 degrees. Each hemithorax will be divided into 4 areas: anterior and lateral, superior and inferior. The anterior area will be delineated between the clavicle and the diaphragm and between the parasternal line to the anterior axillary line. The lateral area will be delineated between the axilla and the diaphragm and between the anterior to the posterior axillary line. The superior area will be delineated from the 1st to the 3rd intercostal space and the lower area from the 4th to the 6th intercostal space. A total of 8 areas of the chest will be visualized during normal breathing.
The TPOCUS findings to report are:
B-type lines: Those lines are hydro-aerial artifacts presenting as comet tail images, begin in the pleural line, are hyper-echoic, well defined, disseminated towards the end of the screen, delete A-type lines, and move with the pleural slip when this it is present. The lines separated from each other around 7 mm correspond to interstitial edema, while those that distance 3 mm indicate the presence of alveolar edema. The presence of more than 3 B-type lines indicates the presence of an alveolar-interstitial syndrome.
The inferior cava vein evaluation will be performed by measuring the diameter and percentage of collapse of this vein. It will be performed in the subxiphoid window with the identification of the four cardiac chambers, then a 90º turn of the transducer will made in the cephalad direction, which will show the right atrium, the union of the inferior vena cava and the liver above it. The diameter measurement will be beyond the point of confluence of the hepatic veins, usually found approximately 2 cm from the union of the inferior vena cava and the right atrium. Based on the diameter and collapse percentage measurement of the inferior vena cava on spontaneous breathing, a volume status will be defined as lack of volume if the diameter is <2 cm and the collapse percentage is >50%; however, a diameter >2 cm and a collapse percentage <50% will be classified as hypervolemic state.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with variceal and non-variceal UGIB, who arrive to the emergency department of the University Hospital, "Dr. José E. González" Universidad Autónoma de Nuevo León.
Key inclusion criteria (3 listed)
- Age, more than 17 years old.
- Patients diagnosed with UGIB.
- Any etiology of the UGIB.
Key exclusion criteria (4 listed)
- Patients with UGIB previously treated in other hospitals.
- Patients with UGIB with Blatchford scale less than 2 points.
- Pregnant women.
- Refusal to participate in the protocol.
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
B-type lines on thoracic point-of-care ultrasound in patients with UGIB.
Time frame: 48 hours
The number of B-type lines measured by thoracic point-of-care ultrasound in patients with variceal and non-variceal UGIB at 48 hours.
Diameter of inferior vena cava on thoracic point-of-care ultrasound in patients with UGIB.
Time frame: 48 hours
The diameter in centimeters of inferior vena cava measured by thoracic point-of-care ultrasound in patients with variceal and non-variceal UGIB at 48 hours.
3 secondary outcomes
B-type lines and mean arterial pressure on UGIB patients
Time frame: 48 hours
Inferior vena cava diameter and Model for End-stage Liver Disease on UGIB patients
Time frame: 48 hours
Inferior vena cava diameter and 48 hours mortality in UGIB patients.
Time frame: 48 hours
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 2 Jan 2020.
- Individual participant dataSharing planned: Yes. If need information will be available upon email contact request.
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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.
Hector Ibarra Sifuentes, M.D. principal investigator
Universidad Autonoma de Nuevo Leon
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 Upper Gastrointestinal Bleeding, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 3 inclusion and 4 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 2 Jan 2020. 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 Mexico. 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?
B-type lines on thoracic point-of-care ultrasound in patients with UGIB. (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2020.