Back to resultsUltrasound to Verify Lung-isolation During Single-lung Ventilation
Primary Purpose
Thoracic Diseases
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Portable, Point-of-Care Ultrasound
Sponsored by
About this trial
This is an interventional other trial for Thoracic Diseases
Eligibility Criteria
Inclusion Criteria:
- Requiring single lung ventilation for thoracic surgery
Exclusion Criteria:
- None
Sites / Locations
- Nationwide Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasonography
Arm Description
Patients requiring single lung ventilation for a surgical procedure will have a bedside ultrasound to evaluate lung isolation.
Outcomes
Primary Outcome Measures
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.
Time to confirm lung isolation
Compare the time required to confirm lung isolation using auscultation, FOB, and ultrasound.
Secondary Outcome Measures
Full Information
NCT ID
NCT03729999
First Posted
October 24, 2018
Last Updated
February 6, 2023
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03729999
Brief Title
Ultrasound to Verify Lung-isolation During Single-lung Ventilation
Official Title
Ultrasound to Verify Lung-isolation During Single-lung Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Diseases
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasonography
Arm Type
Experimental
Arm Description
Patients requiring single lung ventilation for a surgical procedure will have a bedside ultrasound to evaluate lung isolation.
Intervention Type
Device
Intervention Name(s)
Portable, Point-of-Care Ultrasound
Other Intervention Name(s)
SonoSite
Intervention Description
Portable ultrasonography done at the bedside.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Within 5 minutes of intubation and single lung ventilation device placement
Title
Time to confirm lung isolation
Description
Compare the time required to confirm lung isolation using auscultation, FOB, and ultrasound.
Time Frame
Within 5 minutes of intubation and single lung ventilation device placement
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Requiring single lung ventilation for thoracic surgery
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Rice-Weimer
Phone
6143553142
Email
julie.rice-weimer@nationwidechildrens.org
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Rice-Weimer, RN
Phone
614-355-3142
Email
julie.rice-weimer@nationwidechildrens.org
First Name & Middle Initial & Last Name & Degree
Alok Moharir, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound to Verify Lung-isolation During Single-lung Ventilation
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