Intra-op POCUS for Identification of Endotracheal Tube Position in the Pediatric Population

Endotracheal Tube Wrongly Placed During Anesthetic Procedure Clinical Trial

— POCUS  

Official title:

Intraoperative Point-of Care Ultrasound for Identification of Endotracheal Tube Position in the Pediatric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031548
• Other study ID #: 5160372
• Status: Completed
• Start date: February 16, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2021
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chest X-ray and/or fluoroscopy is not routinely used in the OR to confirm endotracheal tube (ETT) placement by anesthesiologists. Multiple studies have shown that ~19% of all intubations result in inappropriate ETT placement. An adult study has shown that ultrasound point-of-care is superior to auscultation in determining the location of ETT. This study aims to determine if point-of-care is useful in determining ETT position in children.

Description:

Patients scheduled to have a procedure in the cardiovascular laboratory where fluoroscopy is routinely used will also undergo a point-of-care ultrasound exam to determine endotracheal tube position. An anesthesiologist will perform the ultrasound exam.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 10 Years

Eligibility

Inclusion Criteria:

1. children birth to 10 years of age;

2. undergoing cardiac catheterization in the cath lab;

3. general anesthesia with an endotracheal tube;

4. subjects will also receive a chest x-ray as standard of care

Exclusion Criteria:

1. children ages birth to 10 years undergoing cardiac catheterization under GA without an endotracheal tube;

2. emergency procedures;

3. known airway anomalies;

4. children who are non-English and non-Spanish speaking -

Related Conditions & MeSH terms

• Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Intervention

Device:
• Point-of-care ultrasound exam
No intervention

Radiation:
• Reposition ETT
ETT will be repositioned based on CXR by fluoroscopy

Locations

Country	Name	City	State
United States	Loma Linda University Department of Anesthesiology	Loma Linda	California
United States	Loma Linda University Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endotracheal Tube Position	The primary outcome marker for this study was the correlation between the weighted POCUS measurement of TT location and the weighted fluoroscopy measurement of TT location	through study completion, an average of 1 year