Trial Outcomes & Findings for Ultrasound to Verify Lung-isolation During Single-lung Ventilation (NCT NCT03729999)
NCT ID: NCT03729999
Last Updated: 2024-12-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Within 5 minutes of intubation and single lung ventilation device placement
Results posted on
2024-12-31
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasound to Verify Lung-isolation During Single-lung Ventilation
Baseline characteristics by cohort
| Measure |
Ultrasonography
n=40 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
|
Weight (kg)
|
18.0 kilograms
n=5 Participants
|
|
Height (cm)
|
106 centimeters
n=5 Participants
|
|
ASA physical status
ASA I
|
1 Participants
n=5 Participants
|
|
ASA physical status
ASA II
|
12 Participants
n=5 Participants
|
|
ASA physical status
ASA III
|
25 Participants
n=5 Participants
|
|
ASA physical status
ASA IV
|
2 Participants
n=5 Participants
|
|
Technique for one lung ventilation (OLV)
Double-lumen tube
|
16 Participants
n=5 Participants
|
|
Technique for one lung ventilation (OLV)
Bronchial blocker
|
5 Participants
n=5 Participants
|
|
Technique for one lung ventilation (OLV)
Bronchial intubation
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 5 minutes of intubation and single lung ventilation device placementUltrasound 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.
Outcome measures
| Measure |
Ultrasonography
n=40 Participants
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.
|
Auscultation
n=40 Participants
Patients requiring single lung ventilation for a surgical procedure will have auscultation via stethoscope to evaluate lung isolation.
|
|---|---|---|
|
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
Interval 83.4 to 99.9
|
65 percent
Interval 46.5 to 79.7
|
|
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
Interval 12.5 to 98.2
|
100 percent
Interval 31.0 to 100.0
|
|
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
Interval 82.7 to 98.5
|
68 percent
Interval 51.5 to 80.4
|
|
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
Interval 83.4 to 99.9
|
100 percent
Interval 81.5 to 100.0
|
|
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
Interval 12.5 to 98.2
|
20 percent
Interval 5.3 to 48.6
|
PRIMARY outcome
Timeframe: Within 5 minutes of intubation and single lung ventilation device placementCompare the time required to confirm lung isolation using auscultation, fiberoptic bronchoscopy (FOB), and ultrasound.
Outcome measures
| Measure |
Ultrasonography
n=40 Participants
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.
|
Auscultation
Patients requiring single lung ventilation for a surgical procedure will have auscultation via stethoscope to evaluate lung isolation.
|
|---|---|---|
|
Time to Confirm Lung Isolation
Total auscultation time
|
21 seconds
Interval 10.0 to 32.0
|
—
|
|
Time to Confirm Lung Isolation
Total FOB time
|
179 seconds
Interval 91.0 to 241.0
|
—
|
|
Time to Confirm Lung Isolation
Total ultrasound time
|
67 seconds
Interval 46.0 to 142.0
|
—
|
Adverse Events
Ultrasonography
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place