Tracheal Ultrasound for Confirmation of ETT Placement in NICU

NCT07073105 | Completed

• 1 other identifier: Tracheal Ultrasound NICU
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preterm Neonates; Mechanical Ventilation; Endotracheal Tube

Keywords

tracheal ultrasound in preterm neonates for ETT confirmation

Outcome Measures

Primary Outcomes (4)

• time in minutes to receive tracheal ultrasound by trainee neonatologist results for ETT site

  Time taken from giving order to perform the tracheal ultrasound by trainee neonatologist to receiving the results of the imaging

  24 hours

• time in minutes to receive CXR results for ETT site

  Time taken from giving order to perform chest x ray to receiving the results of the imaging

  24 hours

• time in minutes to receive tracheal ultrasound by expert radiologist results for ETT site

  Time taken from giving order to perform the tracheal ultrasound by expert radiologist to receiving the results of the imaging

  24 hours

• reproducibility of results between CXR , expert and trainee tracheal ultrasound

  Accuracy of the findings of the tracheal ultrasound by expert, trainee and chest x ray for the same patient

  24 hours

Study Arms (3)

confirmation of ETT by CXR

ACTIVE COMPARATOR

confirmation of ETT site by CXR the gold standard

Diagnostic Test: Chest x-ray

ETT site confirmation by trainee tracheal ultrasound

EXPERIMENTAL

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

Diagnostic Test: tracheal ultrasound by trainee neonatologist

ETT site confirmation by expert tracheal ultrasound

EXPERIMENTAL

confirmation of ETT tube site by expert radiologist performing tracheal ultrasound

Diagnostic Test: tracheal ultrasound ( expert radiologist)

Interventions

tracheal ultrasound ( expert radiologist) DIAGNOSTIC_TEST

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

ETT site confirmation by expert tracheal ultrasound

tracheal ultrasound by trainee neonatologist 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 trainee tracheal ultrasound

Chest x-ray DIAGNOSTIC_TEST

chest xray done for confirmation of ETT site

confirmation of ETT by CXR

Eligibility Criteria

• Age: 1 Hour - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Upper air way anomalies.
• eligible patients whose care team deemed enrollment will disrupt patient care.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

Related Publications (1)

• Ibrahim MJA, Elbarbary MNED, Yacoub GEE, Abdo MAM. Confirmation and reproducibility of endotracheal tube position by tracheal ultrasonography in preterms: expert versus trainee. Eur J Pediatr. 2025 Dec 9;185(1):2. doi: 10.1007/s00431-025-06626-3.

  PMID: 41364152 DERIVED

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• mariam ibrahim, MD, PHD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of paediatrics and neonatology , Ain shams University

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 18, 2025
• Study Start: June 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: after publication
• Access Criteria: from the coresponding author

Locations

EG (1)