Tracheal Ultrasound for Confirmation of ETT Placement in NICU

NCT ID: NCT07073105

Last Updated: 2025-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-06-01

Brief Summary

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Improper placement of the endotracheal tube during intubation can lead to dangerous complications. It has been reported that chest radiography is the gold standard method for validation of endotracheal tube (ET) position .

This study will compare the effectiveness of endotracheal tube position obtained by ultrasonography vs that obtained by chest X-ray with two operators an expert and a trainee in preterm neonates.

This study will work to the extent that the trainee has the ability to do sonar for premature babies with the same efficiency as an ultrasound specialist.

Detailed Description

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neonate in the neonatal intensive care unit (NICU) are intubated for different reasons and most of these patients undergo chest X-rays (CXRs) several times during their ICU admission to confirm endotracheal tube (ETT) placement, monitor severity of cardiopulmonary illness, and detect complications of other indwelling devices Although the amount of radiation exposure is minimal with CXRs, exposure to multiple CXRs in NICU patients, especially in preterm, results in accumulated radiation burden over time. This can lead to tissue damage and is associated with an increased risk of malignancy Tracheal ultrasonography is technique for confirmation of proper endotracheal intubation. Potential advantages include detection of both main stem and esophageal intubation and less time to image availability than CXR and less radiation Point of care ultrasound (POCUS) of the anterior neck is increasingly used by emergency physicians and anesthesiologists to detect endotracheal and esophageal intubation. It is more accurate and faster than physical examination and capnography, with adult meta-analyses reporting that it has sensitivities of 93-98%, specificities of 97-98% We will explore effectiveness and reproducibility of tracheal ultrasonography done by in hospital neonatologist trainee in the technique vs the expert radiologist in determination of ET position.

Conditions

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Preterm Neonates Mechanical Ventilation Endotracheal Tube

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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confirmation of ETT by CXR

confirmation of ETT site by CXR the gold standard

Group Type ACTIVE_COMPARATOR

Chest x-ray

Intervention Type DIAGNOSTIC_TEST

chest xray done for confirmation of ETT site

ETT site confirmation by trainee tracheal ultrasound

confirmation of ETT site was done by tracheal ultrasound performed by a trainee neonatologist after receiving training for the procedure

Group Type EXPERIMENTAL

tracheal ultrasound by trainee neonatologist

Intervention Type DIAGNOSTIC_TEST

tracheal ultrasound, performed by trainee neonatologist ( after receiving training for the procedure) , for preterm neonates for confirmation of ETT site

ETT site confirmation by expert tracheal ultrasound

confirmation of ETT tube site by expert radiologist performing tracheal ultrasound

Group Type EXPERIMENTAL

tracheal ultrasound ( expert radiologist)

Intervention Type DIAGNOSTIC_TEST

tracheal ultrasound, performed by expert radiologist, for preterm neonates for confirmation of ETT site

Interventions

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tracheal ultrasound ( expert radiologist)

tracheal ultrasound, performed by expert radiologist, for preterm neonates for confirmation of ETT site

Intervention Type DIAGNOSTIC_TEST

tracheal ultrasound by trainee neonatologist

tracheal ultrasound, performed by trainee neonatologist ( after receiving training for the procedure) , for preterm neonates for confirmation of ETT site

Intervention Type DIAGNOSTIC_TEST

Chest x-ray

chest xray done for confirmation of ETT site

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Less than 35weeks gestational age
* Invasive mechanical ventilation via ETT.

Exclusion Criteria

* Upper air way anomalies.
* eligible patients whose care team deemed enrollment will disrupt patient care.
Minimum Eligible Age

1 Hour

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mariam Ibrahim

Assistant Professor of paediatrics and neonatology , Ain shams University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mariam ibrahim, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain Shams University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Tracheal Ultrasound NICU

Identifier Type: -

Identifier Source: org_study_id

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