Thoracic DiseasesNCT03729999

Ultrasound to Verify Lung-isolation During Single-lung Ventilation

A study testing Portable, Point-of-Care Ultrasound in people with Thoracic Diseases, run by Nationwide Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 18 years
Conditions the study is for: Thoracic Diseases
What is being tested?: Portable, Point-of-Care Ultrasound
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 12 Dec 2018to 27 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Requiring single lung ventilation for thoracic surgery

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Nationwide Children's Hospital
Columbus, Ohio, 43205

Other trials in United States

About this study

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).

Conditions: Thoracic Diseases
Being tested: Portable, Point-of-Care Ultrasound
Medical subject headings: Thoracic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Portable, Point-of-Care UltrasoundDevice
Also called SonoSite
Portable ultrasonography done at the bedside.

Study groups in NCT03729999
Study group	Role	What they receive
Ultrasonography	Experimental	Patients requiring single lung ventilation for a surgical procedure will have a bedside ultrasound to evaluate lung isolation. Receives: Device: Portable, Point-of-Care Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Within 5 minutes of intubation and single lung ventilation device placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 201827 Nov 2023

First posted5 Nov 2018
Study start12 Dec 2018
Primary completion27 Nov 2023
Study completion27 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03729999
Sponsor's protocol ID: IRB18-01036
Status last verified: Dec 2024
First submitted: 24 Oct 2018
Last updated: 31 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Thoracic Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ultrasound to Verify Lung-isolation During Single-lung Ventilation
ClinicalTrials.gov ID: NCT03729999
Acronym / sponsor ID: IRB18-01036
Conditions: Thoracic Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Nationwide Children's HospitalUniversity, hospital or other
Study start: 12 Dec 2018 (actual)
Primary completion: 27 Nov 2023 (actual)
Study completion: 27 Nov 2023 (actual)
First posted: 5 Nov 2018 (actual)
Results: Posted 31 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ultrasonography	Experimental	Device: Portable, Point-of-Care UltrasoundPatients requiring single lung ventilation for a surgical procedure will have a bedside ultrasound to evaluate lung isolation.

Who may qualify

Ages: Up to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Requiring single lung ventilation for thoracic surgery

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Portable, Point-of-Care UltrasoundAlso: SonoSitePortable ultrasonography done at the bedside.	Device	Ultrasonography

Primary outcome

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 lung auscultation for assessing lung isolation, which along with FOB is the current accepted standards of care.
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, fiberoptic bronchoscopy (FOB), and ultrasound.

Results and safety

Results posted to the registry on 31 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ultrasonography	40	40

Primary outcome: 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. Number (95% Confidence Interval). Unit: percent

Measure	Ultrasonography n = 40	Auscultation n = 40
Sensitivity	97 (83.4 to 99.9)	65 (46.5 to 79.7)
Specificity	67 (12.5 to 98.2)	100 (31.0 to 100)
Accuracy	95 (82.7 to 98.5)	68 (51.5 to 80.4)
Positive predictive value (PPV)	97 (83.4 to 99.9)	100 (81.5 to 100)
Negative predictive value (NPV)	67 (12.5 to 98.2)	20 (5.3 to 48.6)

Primary outcome: Time to Confirm Lung Isolation

Time frame: Within 5 minutes of intubation and single lung ventilation device placement. Median (Inter-Quartile Range). Unit: seconds

Measure	Ultrasonography n = 40
Total FOB time	179 (91 to 241)
Total auscultation time	21 (10 to 32)
Total ultrasound time	67 (46 to 142)

Adverse events

Time frame: 1 day. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ultrasonography	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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RecruitingObservational study
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Portable, Point-of-Care Ultrasound in people with Thoracic Diseases, run by Nationwide Children's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03729999.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.