Ultrasound to Verify Lung-isolation During Single-lung Ventilation

Thoracic Diseases Clinical Trial

Official title:

Ultrasound to Verify Lung-isolation During Single-lung Ventilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03729999
• Other study ID #: IRB18-01036
• Status: Completed
• Phase: N/A
• Start date: December 12, 2018
• Est. completion date: November 27, 2023

Study information

• Verified date: January 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 27, 2023
• Est. primary completion date: November 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Requiring single lung ventilation for thoracic surgery

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Thoracic Diseases

Intervention

Device:
• Portable, Point-of-Care Ultrasound
Portable ultrasonography done at the bedside.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 use of fiberoptic bronchoscopy and lung auscultation for assessing lung isolation, which are the current accepted standards of care.	Within 5 minutes of intubation and single lung ventilation device placement
Primary	Time to confirm lung isolation	Compare the time required to confirm lung isolation using auscultation, FOB, and ultrasound.	Within 5 minutes of intubation and single lung ventilation device placement