Ultrasound to Verify Lung-isolation During Single-lung Ventilation

NCT03729999 | Completed Results FDA Device

• 1 other identifier: IRB18-01036
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the current study is to prospectively evaluate the usefulness of thoracic ultrasonography in demonstrating effective lung isolation during single-lung ventilation (SLV) in the pediatric patient. The primary hypothesis is that ultrasonography will accurately verify lung separation during SLV, as compared to fiberoptic bronchoscope (FOB).

Conditions

Thoracic Diseases

Outcome Measures

Primary Outcomes (2)

• The Accuracy of Using Ultrasound to Assess Lung Isolation by Visualizing Lung Movement or Lack Thereof of Both the Operative and Non-operative Lung Fields.

  Ultrasound will be used to look for lung sliding in the ventilated lung field and lack of lung sliding and presence of lung pulse on the operative/isolated lung field. The effectiveness of this modality will also be compared to the lung auscultation for assessing lung isolation, which along with FOB is the current accepted standards of care.

  Within 5 minutes of intubation and single lung ventilation device placement

• Time to Confirm Lung Isolation

  Compare the time required to confirm lung isolation using auscultation, fiberoptic bronchoscopy (FOB), and ultrasound.

  Within 5 minutes of intubation and single lung ventilation device placement

Study Arms (1)

Ultrasonography

EXPERIMENTAL

Patients requiring single lung ventilation for a surgical procedure will have a bedside ultrasound to evaluate lung isolation.

Device: Portable, Point-of-Care Ultrasound

Interventions

Portable, Point-of-Care Ultrasound DEVICE

Portable ultrasonography done at the bedside.

Also known as: SonoSite

Ultrasonography

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Requiring single lung ventilation for thoracic surgery

You may not qualify if:

• None

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Alok Moharir
• Organization: Nationwide Children's Hospital

alok.moharir@nationwidechildrens.org

614-722-4200

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 5, 2018
• Study Start: December 12, 2018
• Primary Completion: November 27, 2023
• Study Completion: November 27, 2023
• Last Updated: December 31, 2024
• Results First Posted: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)