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Completed

NCT Number: NCT07073105

Tracheal Ultrasound for Confirmation of ETT Placement in NICU

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.

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Key information

Conditions

Preterm Neonates Endotracheal Tube Mechanical Ventilation

Age range

1 hour–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tracheal ultrasound ( expert radiologist)

Diagnostic Test

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

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

Chest X-Ray

Diagnostic Test

chest xray done for confirmation of ETT site

Primary outcomes

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

    Time frame: 24 hours

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

  2. time in minutes to receive CXR results for ETT site

    Time frame: 24 hours

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

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

    Time frame: 24 hours

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

  4. reproducibility of results between CXR , expert and trainee tracheal ultrasound

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Ultrasonography for Confirmation of Endotracheal Tube Placement in Preterm in Neonatal Intensive Care Unit: Expert Versus Trainee

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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