Back to resultsUltrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
Primary Purpose
Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
ultrasonography (US)
Standard routine (SR)
Sponsored by
About this trial
This is an interventional diagnostic trial for Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation focused on measuring Point-of-care ultrasound,ultrasound
Eligibility Criteria
Inclusion Criteria:
- Clinical indication of nasogastric tube placement
- Age than 20 years old.
Exclusion criteria:
- Facial trauma or head-base fractures
- Esophageal or gastric resection
- Esophageal strictures or alkaline injury
- Open wound in the area to prevent ultrasonography
Sites / Locations
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ultrasonography (US)
Standard routine (SR)
Arm Description
Outcomes
Primary Outcome Measures
correct rate as comparing with the chest radiography in each group
Secondary Outcome Measures
procedure time, tube placement confirmation time other than chest radiography method, and additional auscultation method in US group
Full Information
NCT ID
NCT04795895
First Posted
March 10, 2021
Last Updated
May 17, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04795895
Brief Title
Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
Official Title
Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation, a Randomization Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Introduction: Data using ultrasonography to confirm correct position of the gastric tube is heterogeneous in approach sites, combination exams, and methodology.
Aim: Find the best strategy to confirm gastric tube placement to avoid immediate complication.
Method: A randomized controlled trial was initiated to compare ultrasonography and standard routine method, using non-inferiority design. The study will be conducted in one medical ICU with 59 beds at a medical center. The primary outcome is the correct rate as comparing with the chest radiography in each group. Total 190 patients is needed with estimated 10% drop-out rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
Keywords
Point-of-care ultrasound,ultrasound
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
190 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ultrasonography (US)
Arm Type
Experimental
Arm Title
Standard routine (SR)
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasonography (US)
Intervention Description
US evaluation was performed after insertion of the tube via subxiphoid approach for tube passing esophagogastric (EG) junction. The tube insertion procedure will be repeated no more than three attempts if no visualization by US.
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard routine (SR)
Intervention Description
Standard routine (SR)
Primary Outcome Measure Information:
Title
correct rate as comparing with the chest radiography in each group
Time Frame
1 day
Secondary Outcome Measure Information:
Title
procedure time, tube placement confirmation time other than chest radiography method, and additional auscultation method in US group
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical indication of nasogastric tube placement
Age than 20 years old.
Exclusion criteria:
Facial trauma or head-base fractures
Esophageal or gastric resection
Esophageal strictures or alkaline injury
Open wound in the area to prevent ultrasonography
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ying-Chun Chien, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Test2
ZIP/Postal Code
test3
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
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