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Clinical Trials/NCT04795895
NCT04795895
Terminated
Not Applicable

Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation, a Randomization Trial

National Taiwan University Hospital1 site in 1 country62 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
Sponsor
National Taiwan University Hospital
Enrollment
62
Locations
1
Primary Endpoint
correct rate as comparing with the chest radiography in each group
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
October 1, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

correct rate as comparing with the chest radiography in each group

Time Frame: 1 day

Secondary Outcomes

  • procedure time, tube placement confirmation time other than chest radiography method, and additional auscultation method in US group(1 day)

Study Sites (1)

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