Evaluation of Prophylactic Endotracheal Intubation | NCT03716466

Studies
Evaluation of Prophylactic Endotracheal Intubation

NCT03716466

Sponsor

University of Texas Southwestern Medical Center

Status

Completed

Last Update Posted

May 23, 2022Actual

Enrollment

65Actual

Phase

Not provided

Conditions

Intubation;Difficult
Gastrointestinal Bleeding

Interventions

Endotracheal intubation
No airway intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 11, 2018Actual

Primary Completion Date

Dec 6, 2018Actual

Completion Date

Jul 9, 2021Actual

First Submitted Date

Sep 28, 2018

First Submission Date that Met QC Criteria

Oct 22, 2018

First Posted Date

Oct 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2022

Last Update Posted Date

May 23, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dawood Nasir, ASSOC PROFESSOR, University of Texas Southwestern Medical CenterPrincipal Investigator

Lead Sponsor

University of Texas Southwestern Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endotracheal intubation		Cases with prophylactic endotracheal intubation during urgent endoscopy procedure for upper gastrointestinal bleeding .	Other: Endotracheal intubation
No airway intervention		Cases without airway intervention during urgent endoscopy procedure for upper gastrointestinal bleeding	Other: No airway intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endotracheal intubation	Other	Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure	Endotracheal intubation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiovascular unplanned event	The number of cardiovascular unplanned event after upper gastrointestinal endoscopy, up to 48 hours	Postoperative up to 48 hours

Secondary Outcomes

Measure	Description	Time Frame
Pulmonary unplanned event	The number of pulmonary unplanned event after upper gastrointestinal endoscopy, up to 48 hours.	Postoperative up to 48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Cases with upper gastrointestinal bleeding.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Nasir, MD	214-590-5352	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Parkland Health Hospital System		Dallas	Texas	750390	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006471	Gastrointestinal Hemorrhage

Ancestor Terms

ID	Term
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D006470	Hemorrhage
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007442	Intubation, Intratracheal

Ancestor Terms

ID	Term
D058109	Airway Management
D013812	Therapeutics
D007440	Intubation
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided