Thoracic Diseases
Conditions
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).
Interventions
DEVICEPortable, Point-of-Care Ultrasound
Portable ultrasonography done at the bedside.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Requiring single lung ventilation for thoracic surgery
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Confirm Lung Isolation | Within 5 minutes of intubation and single lung ventilation device placement | Compare the time required to confirm lung isolation using auscultation, fiberoptic bronchoscopy (FOB), and ultrasound. |
| 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. | 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 lung auscultation for assessing lung isolation, which along with FOB is the current accepted standards of care. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Ultrasonography |
|---|---|
| Age, Categorical <=18 years | 40 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 4.9 years |
| ASA physical status ASA I | 1 Participants |
| ASA physical status ASA II | 12 Participants |
| ASA physical status ASA III | 25 Participants |
| ASA physical status ASA IV | 2 Participants |
| Height (cm) | 106 centimeters |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 40 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 23 Participants |
| Technique for one lung ventilation (OLV) Bronchial blocker | 5 Participants |
| Technique for one lung ventilation (OLV) Bronchial intubation | 19 Participants |
| Technique for one lung ventilation (OLV) Double-lumen tube | 16 Participants |
| Weight (kg) | 18.0 kilograms |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
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.
Time frame: Within 5 minutes of intubation and single lung ventilation device placement
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ultrasonography | 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. | Specificity | 67 percent |
| Ultrasonography | 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. | Positive predictive value (PPV) | 97 percent |
| Ultrasonography | 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. | Accuracy | 95 percent |
| Ultrasonography | 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. | Negative predictive value (NPV) | 67 percent |
| Ultrasonography | 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. | Sensitivity | 97 percent |
| Auscultation | 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. | Negative predictive value (NPV) | 20 percent |
| Auscultation | 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. | Sensitivity | 65 percent |
| Auscultation | 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. | Specificity | 100 percent |
| Auscultation | 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. | Accuracy | 68 percent |
| Auscultation | 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. | Positive predictive value (PPV) | 100 percent |
Primary
Time to Confirm Lung Isolation
Compare the time required to confirm lung isolation using auscultation, fiberoptic bronchoscopy (FOB), and ultrasound.
Time frame: Within 5 minutes of intubation and single lung ventilation device placement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Ultrasonography | Time to Confirm Lung Isolation | Total FOB time | 179 seconds |
| Ultrasonography | Time to Confirm Lung Isolation | Total auscultation time | 21 seconds |
| Ultrasonography | Time to Confirm Lung Isolation | Total ultrasound time | 67 seconds |