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

Not Applicable

Terminated

• Conditions: Ultrasound for Confirmation of Gastric Tube Placement in Critically Ill Patients Under Invasive Mechanical Ventilation
• Interventions: Diagnostic Test: Standard routine (SR); Diagnostic Test: ultrasonography (US)

• Registration Number: NCT04795895
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-10
• Study First Posted: 2021-03-12
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard routine (SR)	Standard routine (SR)	-
ultrasonography (US)	ultrasonography (US)	-

Primary Outcome Measures

Name	Time	Method
correct rate as comparing with the chest radiography in each group	1 day

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Test2, Taiwan