Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2026-01-01 @ 6:23 AM
Study NCT ID:
NCT07073105
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2025-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tracheal Ultrasound for Confirmation of ETT Placement in NICU
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Ultrasonography for Confirmation of Endotracheal Tube Placement in Preterm in Neonatal Intensive Care Unit: Expert Versus Trainee
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: