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

NCT03031548 | Completed

• 1 other identifier: 5160372
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Endotracheal Tube Wrongly Placed During Anesthetic Procedure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ultrasound exam

Child undergoing procedure in CVL requiring ETT and CXR as standard of care - received point-of-care ultrasound exam as part of the study

Device: Point-of-care ultrasound exam; Radiation: Reposition ETT

Interventions

Point-of-care ultrasound exam DEVICE

No intervention

Also known as: POC ultrasound

ultrasound exam

Reposition ETT RADIATION

ETT will be repositioned based on CXR by fluoroscopy

ultrasound exam

Eligibility Criteria

• Age: 1 Minute - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children who require general anesthesia and endotracheal intubation for procedures in the cardiovascular laboratory

You may qualify if:

• children birth to 10 years of age;
• undergoing cardiac catheterization in the cath lab;
• general anesthesia with an endotracheal tube;
• subjects will also receive a chest x-ray as standard of care

You may not qualify if:

• children ages birth to 10 years undergoing cardiac catheterization under GA without an endotracheal tube;
• emergency procedures;
• known airway anomalies;
• children who are non-English and non-Spanish speaking -

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (2)

Loma Linda University Health

Loma Linda, California, 92350, United States

Location

Loma Linda University Department of Anesthesiology

Loma Linda, California, 92354, United States

Location

Study Officials

• Elizabeth Ghazal, MD

  Loma Linda University Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 25, 2017
• Study Start: February 16, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)