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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04795895
• Other study ID #: 201907167RINB
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: October 2023

Study information

• Verified date: May 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Standard routine (SR)
Standard routine (SR)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Test2

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correct rate as comparing with the chest radiography in each group		1 day
Secondary	procedure time, tube placement confirmation time other than chest radiography method, and additional auscultation method in US group		1 day