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

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

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.

Study Overview

• Status: Completed
• Conditions: Endotracheal Tube Wrongly Placed During Anesthetic Procedure
• Intervention / Treatment: Device: Point-of-care ultrasound exam; Radiation: Reposition ETT

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University Health
    • Loma Linda, California, United States, 92354
      • Loma Linda University Department of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 -

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; No intervention; Other Names: POC ultrasound; Radiation: Reposition ETT; ETT will be repositioned based on CXR by fluoroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Elizabeth Ghazal, MD, Loma Linda University Health

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 11, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 5160372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No