Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
• Intervention / Treatment: Diagnostic test: ultrasonography (US); Diagnostic test: Standard routine (SR)

• Study Type: Interventional
• Enrollment (Anticipated): 190
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying-Chun Chien, MD; Phone Number: 62905 886-2-23123456; Email: 019466@ntuh.gov.tw
• Study Contact Backup: Name: Chien Chien

Study Locations

• Taiwan
  • Test2
    • Taipei, Test2, Taiwan, test3
      • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ultrasonography (US)	Diagnostic test: ultrasonography (US); 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.
Active Comparator: Standard routine (SR)	Diagnostic test: Standard routine (SR); Standard routine (SR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
correct rate as comparing with the chest radiography in each group	1 day

Secondary Outcome Measures

Outcome Measure	Time Frame
procedure time, tube placement confirmation time other than chest radiography method, and additional auscultation method in US group	1 day

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Ying-Chun Chien, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Point-of-care ultrasound,ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 201907167RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No