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Ultrasound to Verify Lung-isolation During Single-lung Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03729999
Recruitment Status : Recruiting
First Posted : November 5, 2018
Last Update Posted : January 11, 2021
Information provided by (Responsible Party):
Alok Moharir, Nationwide Children's Hospital

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).

Condition or disease Intervention/treatment Phase
Thoracic Diseases Device: Portable, Point-of-Care Ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Ultrasound to Verify Lung-isolation During Single-lung Ventilation
Actual Study Start Date : December 12, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ultrasonography
Patients requiring single lung ventilation for a surgical procedure will have a bedside ultrasound to evaluate lung isolation.
Device: Portable, Point-of-Care Ultrasound
Portable ultrasonography done at the bedside.
Other Name: SonoSite

Primary Outcome Measures :
  1. 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. [ Time Frame: Within 5 minutes of intubation and single lung ventilation device placement ]
    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.

  2. Time to confirm lung isolation [ Time Frame: Within 5 minutes of intubation and single lung ventilation device placement ]
    Compare the time required to confirm lung isolation using auscultation, FOB, and ultrasound.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Requiring single lung ventilation for thoracic surgery

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03729999

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Contact: Julie Rice-Weimer 6143553142

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United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Julie Rice-Weimer, RN    614-355-3142   
Principal Investigator: Alok Moharir, MD         
Sponsors and Collaborators
Nationwide Children's Hospital
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Responsible Party: Alok Moharir, Clinical Assistant Professor of Anesthesiology, Nationwide Children's Hospital Identifier: NCT03729999    
Other Study ID Numbers: IRB18-01036
First Posted: November 5, 2018    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Thoracic Diseases
Respiratory Tract Diseases