Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonography | Experimental | Patients requiring single lung ventilation for a surgical procedure will have a bedside ultrasound to evaluate lung isolation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable, Point-of-Care Ultrasound | Device | Portable ultrasonography done at the bedside. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasonography | Patients requiring single lung ventilation for a surgical procedure will have a bedside ultrasound to evaluate lung isolation. Portable, Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasonography | Patients requiring single lung ventilation for a surgical procedure will have a bedside ultrasound to evaluate lung isolation. Portable, Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 lung auscultation for assessing lung isolation, which along with FOB is the current accepted standards of care. | Posted | Number | 95% Confidence Interval | percent | Within 5 minutes of intubation and single lung ventilation device placement |
|
1 day
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ultrasonography | Patients requiring single lung ventilation for a surgical procedure will have a bedside ultrasound to evaluate lung isolation. Portable, Point-of-Care Ultrasound: Portable ultrasonography done at the bedside. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alok Moharir | Nationwide Children's Hospital | 614-722-4200 | alok.moharir@nationwidechildrens.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2019 | Dec 5, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D013896 | Thoracic Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (kg) | Median | Inter-Quartile Range | kilograms |
|
| Height (cm) | Median | Inter-Quartile Range | centimeters |
|
| ASA physical status | A grading system that assigns a class from I to VI, with higher numbers indicating a greater risk of complications | Count of Participants | Participants |
|
| Technique for one lung ventilation (OLV) | Count of Participants | Participants |
|
| OG001 |
| Auscultation |
Patients requiring single lung ventilation for a surgical procedure will have auscultation via stethoscope to evaluate lung isolation. |
|
|
| Primary | Time to Confirm Lung Isolation | Compare the time required to confirm lung isolation using auscultation, fiberoptic bronchoscopy (FOB), and ultrasound. | Posted | Median | Inter-Quartile Range | seconds | Within 5 minutes of intubation and single lung ventilation device placement |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|