Intubation;DifficultNCT03716466
Evaluation of Prophylactic Endotracheal Intubation
An observational study of Intubation;Difficult and Gastrointestinal Bleeding, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Upper gastrointestinal (GI) bleeding is defined as patients who either presented with hematemesis or presented with melena along with evidence of hemodynamic compromise. These patients have risk of aspiration of blood along with gastric content. The mortality rate can be 15% to 20% in the cases with variceal bleeding. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intubation;Difficult, Gastrointestinal Bleeding
- What is being tested?
- Endotracheal intubation and No airway intervention
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2018to 9 Jul 2021
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Cases with upper gastrointestinal bleeding.
Who may be able to join
- Age 18 years and older
- Presence of upper gastrointestinal bleeding either presented with hematemesis or melena along with evidence of hemodynamic compromise.
- Received procedural (conscious) sedation
- Undergoing urgent upper gastrointestinal endoscopy procedures
Who cannot join
- Intubation other than airway protection
- Prior tracheostomy before onset of gastrointestinal bleeding
- Subjects intubated before transfer to gastrointestinal suite
- Subjects without hemodynamic instability
- Subjects with a diagnosis of pneumonia, acute respiratory distress syndrome, myocardial infarction, pulmonary edema, arrhythmia, or cardiac arrest before endoscopy
- Endoscopy done for other than upper gastrointestinal bleeding
- Pregnant subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
Parkland Health Hospital System
Dallas, Texas, 750390
About this study
Official title: Evaluation of Prophylactic Endotracheal Intubation in the Patients With Upper Gastrointestinal Bleeding Undergoing Urgent Endoscopy: A Prospective Observational Study
Upper gastrointestinal (GI) bleeding is defined as patients who either presented with hematemesis or presented with melena along with evidence of hemodynamic compromise. These patients have risk of aspiration of blood along with gastric content. The mortality rate can be 15% to 20% in the cases with variceal bleeding. From a practical standpoint, it is widely accepted that the best way to secure an airway during upper GI bleeding is prophylactic endotracheal intubation (PEI). The aim of this study is to determine the incidence of complications among critically ill patients with upper GI bleeding and received urgent endoscopy.
Read the detailed description
This is a prospective observational study. After IRB approval, consecutive patient with upper GI bleeding and undergoing urgent endoscopy will be enrolled to the study over 24 months period. Data pull will be requested from Parkland Office of Research Administration (ORA) regarding eligible subjects and protocol requiring data elements. The data pull will be requested at the end of the 24 months-period.
Primary endpoint:
The incidence of cardiovascular unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure.
Secondary end points:
The incidence of pulmonary unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure.
- Conditions
- Intubation;Difficult, Gastrointestinal Bleeding
- Being tested
- Endotracheal intubation, No airway intervention
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endotracheal intubationOther
Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure
No airway interventionOther
Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure
| Study group | Role | What they receive |
|---|---|---|
| Endotracheal intubation | Cases with prophylactic endotracheal intubation during urgent endoscopy procedure for upper gastrointestinal bleeding . Receives: Other: Endotracheal intubation | |
| No airway intervention | Cases without airway intervention during urgent endoscopy procedure for upper gastrointestinal bleeding Receives: Other: No airway intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular unplanned event
The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours
Measured: Postoperative up to 48 hours
Secondary outcomes (1)
Pulmonary unplanned event
The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours.
Measured: Postoperative up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start11 Nov 2018
- Primary completion6 Dec 2018
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation;DifficultStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawood Nasir, University of Texas Southwestern Medical Center
- Investigators
- David Nasir, MD, Study director, 214-590-5352
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716466
- Sponsor's protocol ID
- STU 072018-045
- Status last verified
- May 2022
- First submitted
- 28 Sep 2018
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prophylactic Endotracheal Intubation in the Patients With Upper Gastrointestinal Bleeding Undergoing Urgent Endoscopy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03716466
- Acronym / sponsor ID
- STU 072018-045
- Conditions
- Intubation;Difficult, Gastrointestinal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 11 Nov 2018 (actual)
- Primary completion
- 6 Dec 2018 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 23 Oct 2018 (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 (GI) bleeding is defined as patients who either presented with hematemesis or presented with melena along with evidence of hemodynamic compromise. These patients have risk of aspiration of blood along with gastric content. The mortality rate can be 15% to 20% in the cases with variceal bleeding. From a practical standpoint, it is widely accepted that the best way to secure an airway during upper GI bleeding is prophylactic endotracheal intubation (PEI). The aim of this study is to determine the incidence of complications among critically ill patients with upper GI bleeding and received urgent endoscopy.
Detailed description
This is a prospective observational study. After IRB approval, consecutive patient with upper GI bleeding and undergoing urgent endoscopy will be enrolled to the study over 24 months period. Data pull will be requested from Parkland Office of Research Administration (ORA) regarding eligible subjects and protocol requiring data elements. The data pull will be requested at the end of the 24 months-period.
Primary endpoint:
The incidence of cardiovascular unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure.
Secondary end points:
The incidence of pulmonary unplanned event within 48 hours of the upper gastrointestinal endoscopy procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endotracheal intubation | – | Other: Endotracheal intubationCases with prophylactic endotracheal intubation during urgent endoscopy procedure for upper gastrointestinal bleeding . |
| No airway intervention | – | Other: No airway interventionCases without airway intervention during urgent endoscopy procedure for upper gastrointestinal bleeding |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Cases with upper gastrointestinal bleeding.
Key inclusion criteria (4 listed)
- Age 18 years and older
- Presence of upper gastrointestinal bleeding either presented with hematemesis or melena along with evidence of hemodynamic compromise.
- Received procedural (conscious) sedation
- Undergoing urgent upper gastrointestinal endoscopy procedures
Key exclusion criteria (7 listed)
- Intubation other than airway protection
- Prior tracheostomy before onset of gastrointestinal bleeding
- Subjects intubated before transfer to gastrointestinal suite
- Subjects without hemodynamic instability
- Subjects with a diagnosis of pneumonia, acute respiratory distress syndrome, myocardial infarction, pulmonary edema, arrhythmia, or cardiac arrest before endoscopy
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 |
|---|---|---|
| Endotracheal intubationSubjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure | Other | Endotracheal intubation |
| No airway interventionSubjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure | Other | No airway intervention |
Primary outcome
Cardiovascular unplanned event
Time frame: Postoperative up to 48 hours
The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours
1 secondary outcome
Pulmonary unplanned event
Time frame: Postoperative up to 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 23 May 2022.
- Individual participant dataSharing planned: No
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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.
David Nasir, MD study director
214-590-5352
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 Intubation;Difficult and Gastrointestinal Bleeding, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 7 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 23 May 2022. 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 United States. 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?
Cardiovascular unplanned event (time frame: Postoperative up to 48 hours). 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 23 May 2022.