NCT04104295

Brief Summary

The purpose of this study is to determine if ultrasound (US), when used by the clinician, can determine the presence of nasogastric tube (NGT) in the stomach of patients admitted to the pediatric intensive care unit (PICU).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

March 24, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

September 24, 2019

Last Update Submit

April 16, 2021

Conditions

Nasogastric Tube

Keywords

nasogastric tubeultrasound

Outcome Measures

Primary Outcomes (1)

  • Correct placement of NG tube

    The operational definition will be the number of correct identification of NG tube position using ultrasound, as compared to the official X-ray read.

    Up to 10 minutes

Study Arms (1)

Ultrasound following X-ray

EXPERIMENTAL

An ultrasound scan of the abdomen within 2 hours of the routine X-ray will be performed by a physician blinded to the X-ray results.

Diagnostic Test: Ultrasound following X-ray

Interventions

Ultrasound following X-rayDIAGNOSTIC_TEST

A short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine X-ray (XR). The performer will be a physician who received a focused training on relevant US views, blinded to the XR image and report.

Also known as: Ultrasound
Ultrasound following X-ray

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • PICU patient undergoing routine NGT insertion by nursing staff

You may not qualify if:

  • Any contraindication for US probe placement such as skin infection and abdominal wounds.
  • Hemodynamically unstable patients.
  • Patients for whom NGT placement will not be verified by XR, such as Ataxia Telangiectasia patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Eitan Neeman, MD

    Yale University - MEDPED Critical Care

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2019

First Posted

September 26, 2019

Study Start

March 24, 2020

Primary Completion

September 30, 2020

Study Completion

January 31, 2021

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share